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Disclaimer: The English language text below is provided by the Translation and Terminology Centre for information only; it confers no rights and imposes no obligations separate from those conferred or imposed by the legislation formally adopted and published. Only the latter is authentic. The original Latvian text uses masculine pronouns in the singular. The Translation and Terminology Centre uses the principle of gender-neutral language in its English translations. In addition, gender-specific Latvian nouns have been translated as gender-neutral terms, e.g. chairperson.

Republic of Latvia

CabinetRegulation No 354

Adopted 20 April 2004

Essential Requirements for Cosmetic Products, Labelling thereof and Procedures for Supervision of Compliance with these Requirements

Issued pursuant toSection 7, Paragraph one of the Law On Conformity Assessment and

Section 21, Paragraph one of the Consumer Rights Protection Law

I. General Provisions

1. These Regulations prescribe the essential requirements for cosmetic products and the labelling thereof, as well as procedures for the supervision of compliance with these requirements in order to ensure the preservation of public health, in observance of economic and technological requirements.

2. Within the meaning of these Regulations, a cosmetic product is a substance or a product which comes into contact with certain external parts of the human body (epidermis, hair system, nails, the lips and external genital organs), or with the teeth and the mucous membranes of the oral cavity and which is used exclusively or principally for the cleaning, perfuming, changing the appearance of, keeping in good condition of the referred to parts of the body, or for the correction of body odours. The basic types of cosmetic products are specified in Annex 1 of these Regulations.

3. The final product within the meaning of these Regulations is a cosmetic product which is placed on the market and made available to the end user, or a prototype thereof (the first sample or a model which is not manufactured in batches and from which the final product is copied or developed).

4. These Regulations do not apply to cosmetic products which contain strontium or the compounds thereof, except strontium lactate, nitrate and carboxylate referred to in Annex 2 to these Regulations; strontium sulphide, chloride, acetate, hydroxide and peroxide, the use of which is permitted in accordance with Annex 3 of these Regulations, as well as strontium lacquers, pigments and salts in the colouring agents referred to in Annex 4 to these Regulations (under reference (3)).

5. A cosmetic product must not cause harm to human health if used under normal or intended circumstances, taking into account the category of the product, the labelling thereof, any

Translation © 2004 Tulkošanas un terminoloģijas centrs (Translation and Terminology Centre)

conditions of use and storage, instructions or information provided by the producer or importer of the cosmetic product.

II. Requirements for the Composition of Cosmetic Products

6. It is prohibited to place on the market a cosmetic product if it contains in the composition thereof:

6.1. any of the ingredients referred to in Annex 2 of these Regulations;6.2. any of the ingredients referred to in Annex 3, Paragraph 1 of these Regulations

which are utilised outside the field of application specified in this Paragraph, as well as without complying with the specified restrictions on use;

6.3. any colouring agents (substances utilised in order to give a certain colour to cosmetic products or to change the colour of the skin, nails or hair) which are not referred to in Annex 4 of these Regulations, except for cosmetic products containing colouring agents which are intended only for the dyeing of hair;

6.4. any of colouring agents referred to in Annex 4 of these Regulations which are utilised outside the field of application specified in this Annex, as well as without complying with the restrictions on use specified in this Annex, except for cosmetic products containing colouring agents which are intended only for the dyeing of hair;

6.5. any preservatives (substances which may be added to a cosmetic product for hindering the development of micro-organisms in the cosmetic product) which are not referred to in Annex 5 of these Regulations;

6.6. any of the preservatives referred to in Annex 5 of these Regulations, which are used in contravention to the restrictions on use specified in this Annex. The substances referred to under reference (1) in this Annex may be added to a cosmetic product in a concentration which differs from that specified in Annex 5 if they are utilised in the cosmetic product for other specific purposes which are indicated on the labelling of the cosmetic product;

6.7. any ultraviolet radiation filters (substances that are present in the composition of sunscreen products in order to block ultraviolet rays and to protect the human skin from the negative effects of such rays) which are not referred to in Annex 6 of these Regulations. The ultraviolet radiation filters referred to in Annex 6 of these Regulations may also be added to other cosmetic products, without exceeding the concentrations specified in this Annex;

6.8. any ultraviolet radiation filters referred to in Annex 6 of these Regulations, which have been used without complying with the specified restrictions on use. These requirements do not apply to ultraviolet radiation filters which have been added in order to protect a cosmetic product from ultraviolet radiation; and

6.9. any substances which have been classified as carcinogenic, mutagenic substances and substances toxic to the reproductive system of Categories One, Two and Three and which are mentioned on the list of chemical substances approved by the Minister for the Environment. The carcinogenic, mutagenic substances and substances toxic to the reproductive system of Category Three may be used in the composition of cosmetic products if the Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers (SCCNFP) has assessed and allowed the use thereof in cosmetic products.

7. Cosmetic products may contain admixtures of the ingredients referred to in Annex 2 of these Regulations if, observing good manufacturing practice, it is not possible to prevent such admixtures and the cosmetic product conforms to the requirements specified in Paragraph 4 of these Regulations.

Translation © 2004 Tulkošanas un terminoloģijas centrs (Translation and Terminology Centre) 2

8. The ingredients referred to in Part II of Annex 3 of these Regulations may be in the composition of a cosmetic product until the date specified in Part II (Column 8) of Annex 3 of these Regulations if the specified restrictions on use are observed.

9. Cosmetic products placed on the Latvian market may contain colouring agents, preservatives and ultraviolet radiation filters which are not referred to in Annexes 4, 5, and 6 of these Regulations. In such case a permit to use the ingredient in a particular cosmetic product shall be issued by the State Sanitary Inspection.

10. The permit referred to in Paragraph 9 of these Regulations shall be issued if the producer of a cosmetic product or a representative thereof, or a person pursuant to the order of which the cosmetic product is manufactured (hereinafter – producer), or a person who is responsible for the placement of the imported cosmetic product on the European Union market (hereinafter – importer) hands in to the State Sanitary Inspection a submission specifying the following information:

10.1. the name of the producer or importer, the number of the registration certificate in the commercial register, the actual address and registered office, the authorisation of the responsible person and a copy of a personal identification document;

10.2. an accurate identification of the ingredient for which the permit is being requested:

10.2.1. The name referred to in Sub-paragraph 46.2.1 of these Regulations; 10.2.2. if the name or number referred to in Sub-paragraph 46.2.1 of these

Regulations does not exist (for example, for ingredients of natural origin), the name of the basic material, the name of the part of the plant or animal utilised as well as names of components of the ingredient, for example, a solvent, shall be specified;10.3. a safety evaluation of the ingredient with regard to human health, taking into

consideration the toxicological characteristics, chemical structure, the level of exposure and utilisation of the ingredient in the specific cosmetic product, in conformity with Sub-paragraphs 58.4 and 58.5 of these Regulations;

10.4. the name and application of the cosmetic product in which the ingredient is intended to be utilised;

10.5. a safety evaluation of the cosmetic product in relation to human health, taking into consideration the general toxicological characteristics, chemical structure and exposure level in conformity with Sub-paragraphs 58.4 and 58.5 of these Regulations; and

10.6. the function of the ingredient in the cosmetic product and benefits of the use of the ingredient compared to the application of the permitted ingredients referred to in Annexes 4, 5, and 6 of these Regulations and a detailed substantiation for the utilisation thereof.

11. The State Sanitary Inspection shall perform an expert examination of the submitted documents in accordance with the procedures and within the time periods specified in Paragraph 48 of these Regulations.

12. The State Sanitary Inspection shall issue a permit for a period of time not longer than three years.

13. The State Sanitary Inspection shall, within a period of a month after issuing the permit referred to in Paragraph 9 of these Regulations, notify thereof the Commission and competent authorities of all Member States of the European Union.


14. Not later than five months before the expiration of the term of validity of the permit referred to in Paragraph 12 of these Regulations, the producer or importer may hand in to the State Sanitary Inspection a submission with a request to include the ingredients permitted in Latvia on the list of colouring agents, preservatives and ultraviolet radiation filters permitted for cosmetic products in the European Union (hereinafter – list of ingredients permitted in the European Union). In such case the results of scientific and clinical research shall be submitted in addition to the information referred to in Paragraph 10 of these Regulations.

15. The State Sanitary Inspection shall, within a period of a month after the receipt of the documents, perform an expert examination thereof and take a motivated decision to support or to refuse support for the admission of an ingredient to the list of permitted ingredients in the European Union. The producer or importer shall be informed in writing regarding the decision taken. If a decision for refusal has been taken, the procedure and time periods for appealing against such decision shall also be specified. If due to objective reasons it is impossible to comply within the time period of a month, the State Sanitary Inspection may extend such for a period not exceeding four months from the day the submission is handed in, notifying the submitter thereof.

16. If a decision is taken for support for the admission of an ingredient to the list of ingredients permitted in the European Union, the State Sanitary Inspection shall, within a period of a month, send to the European Commission an application for admission of the ingredient to the list of ingredients permitted in the European Union. Documents, which substantiate such admission and indicate the function of the ingredient in the cosmetic product shall be appended to the application. In such case the term of validity of the permit referred to in Paragraph 12 of these Regulations shall be extended until the decision regarding the application for admission of an ingredient to the list of ingredients permitted in the European Union is taken, but not longer than 18 months from the receipt of the application at the European Commission.

17. If a cosmetic product, on the basis of the permit issued by the State Sanitary Inspection, contains in the composition thereof an ingredient referred to in Paragraph 9 of these Regulations, the labelling of the cosmetic product shall contain a special reference regarding the presence of the ingredient in the cosmetic product.

18. It is prohibited to place on the Latvian market a cosmetic product:18.1. the check on the conformity of the end product of which has been performed

utilising animals, if alternative methods (for the determination of toxicity and other health effects) referred to in Annex 7 of these Regulations (hereinafter – alternative test methods) are applicable; and

18.2. which contains ingredients or combinations of ingredients the check on the conformity of which has been performed utilising animals, if alternative test methods are applicable.

19. It is prohibited in Latvia to use animals:19.1. for the testing of the end product of a cosmetic product in order to determine the

conformity thereof with the requirements of these Regulations; and19.2. for the testing of ingredients of a cosmetic product or a combination of cosmetic

products if alternative testing methods are applicable.


20. For determining the chemical composition of a cosmetic product, the standard methods referred to in Annex 8 of these Regulations shall be utilised.

21. The criteria for microbiological purity of a cosmetic product and methods for the ascertainment thereof are specified in Annex 9 of these Regulations.

III. Requirements for the Labelling of Cosmetic Products

22. The information included on the labelling of a cosmetic product may not be misleading with regard to the identity, characteristics, functions, composition and properties of the ingredients, the quantity, date of minimum term of fitness for use (date until which the cosmetic product retains the specific characteristics and function thereof and conforms with the safety requirements if the prescribed storage regime is observed), origins, conditions of use and potential risk upon the usage thereof.

23. It is prohibited to use such text, names, trademarks, pictures or pictograms (an information sign in the form of a stylised picture) in the labelling of a cosmetic product which gives the impression that this cosmetic product has properties which it actually does not have.

24. The labelling of a cosmetic product shall be on the primary packaging of the cosmetic product (which has direct contact with the cosmetic product) as well as on the packaging in which the primary packaging is placed, whereas the information referred to in Sub-paragraph 25.7 of these Regulations may be only on the packaging in which the primary packaging is placed. Labelling shall be indelible and easily legible.

25. The following information shall be specified on the labelling of cosmetic products:25.1. the name of the cosmetic product;25.2. the name and address of the producer of the cosmetic product or of the person

responsible for the first placement on the European Union market of the imported cosmetic product. This information may be abbreviated if the abbreviation allows for identification of the referred to persons;

25.3. information regarding the state of origin of the cosmetic product if it has been manufactured outside the European Union;

25.4. the net mass or volume during packaging of the cosmetic product, except for cases referred to in Paragraph 26;

25.5. the minimum term for using the cosmetic product, except for cases referred to in Paragraph 30 of these Regulations;

25.6. the functions (application) of the cosmetic product if the use of the cosmetic product may not be convincingly judged from the presentation thereof;

25.7. the list of ingredients of the cosmetic product (substances or preparations of synthetic or natural origin, except for the aroma and aromatic compositions which are used in the composition of a cosmetic product);

25.8. the batch number, code or other features of the cosmetic product that allow for identification of the batch of the cosmetic product; and

25.9. conditions for use and warnings, particularly if such are referred to in Annexes 3, 4, 5 and 6 of these Regulations, as well as any warning information related to the professional utilisation of a cosmetic product.


26. The labelling requirements referred to in Paragraph 25 of these Regulations shall also apply to cosmetic products which have not been previously packaged or which have been packaged at the location of sale thereof prior to the sale in conformity with the quantity requested by the consumer or which are packaged for immediate sale. In such case the information shall be indicated on the annotation attached to the cosmetic product, on a label, a tape or a leaflet.

27. The net weight or volume need not be indicated:27.1. for a cosmetic product the net weight of which is less than five grams or the net

volume of which is less than five millilitres;27.2. on the packaging of a cosmetic product intended for a single use;27.3. for a pre-packaged cosmetic product if the packaging contains several identical

units of the cosmetic product which are normally sold as a unified whole and for which an indication of weight or volume is not significant, if the number of units is indicated on the packaging. The referred to indication shall not be mandatory if the units are not sold as a unified whole or the units contained in the packaging are visible and may be counted without opening the packaging; or

27.4. for a cosmetic product which is distributed to a consumer free of charge for promotional purposes.

28. The labelling of a cosmetic product shall contain the words “Ieteicams līdz … beigām” [Best before the end of…], and the date or a reference to the place where the date is indicated on the labelling shall be specified before the indication of minimum term of fitness for use. The date of minimum term of fitness for use shall be specified in the following order – the month and year or day, month and year.

29. If necessary, the labelling of a cosmetic product shall indicate the storage regime, which must be observed so that the cosmetic product may preserve the specific characteristics thereof during the minimum term of fitness for use.

30. The minimum term of fitness for use need not be indicated for a cosmetic product the minimum term of fitness for use of which exceeds 30 months. The labelling of such cosmetic product shall specify the symbol indicated in Annex 10 of these Regulations and the period of time (months and/or years) after the opening thereof within which the cosmetic product may be used without any harm to the consumer.

31. The labelling of a cosmetic product shall specify the ingredients in decreasing order of weight, in conformity with the initially added quantity thereof. At the top of a list of ingredients there shall be the word “Sastāvdaļas” [ingredients] or “Ingredienti” [ingredients].

32. The ingredients of a cosmetic product the concentration of which in a product is lower than one per cent may be specified in any order after the ingredients the concentration of which in the product exceeds one per cent.

33. Perfume and aromatic compositions and the raw materials thereof shall be specified on the list of ingredients in conformity with the International Nomenclature for Cosmetic Ingredients (INCI) (hereinafter – INCI) with the word “Parfum” or “Aroma”. Ingredients of perfume compositions the presence of which must be specified in conformity with the column “Other restrictions and requirements” in Annex 3 of these Regulations shall be specified in the list of ingredients irrespective of their function in a cosmetic product.


34. The list of ingredients of a make-up product manufactured in various shades of colour shall specify all the colouring agents used in the relevant shades, adding the words “Sastāvā var būt” [Product may contain] or the symbol “+/–”.

35. Colouring agents may be indicated in any order after the other ingredients in a cosmetic product according to the colouring agent index number or name of the colouring agent in conformity with Annex 4 of these Regulations. If a colouring agent is added to a cosmetic product for other purposes, the name of the ingredient shall be specified on the labelling in conformity with the INCI.

36. The names of ingredients shall be specified in conformity with the names mentioned in the INCI. If the name of the relevant ingredient is not mentioned in the INCI, another alternative international name shall be specified according to the types specified in the INCI, including:

36.1. the name according to the Cosmetic, Toiletry and Fragrance Association (CTFA);

36.2. the name according to European Pharmacopoeia;36.3. the international non-proprietary name recommended by the World Health

Organisation; 36.4. the name according to the nomenclature of the International Union of Pure and

Applied Chemistry (IUPAC) (hereinafter – IUPAC);36.5. the name referred to in the European Inventory of Existing Chemical Substances

(EINECS) (hereinafter – EINECS);36.6. the name and number referred to in the European List of Notified Chemical

Substances (ELINCS) (hereinafter – ELINCS); and36.7. the registration number of the chemical substance in the chemical abstract

magazine Chemical Abstracts Services (hereinafter – CAS issue).

37. If an ingredient in a cosmetic product contains several substances, each substance shall be separately indicated on the labelling.

38. The following shall not be regarded as ingredients of a cosmetic product:38.1. residue elements of raw materials;38.2. technological ancillary substances utilised in the process of manufacturing but

not present in the end product; and38.3. substances that are utilised in precisely specified quantities as solvents or free-

flowing agents in perfume and aromatic compositions.

39. If due to practical reasons it is impossible to indicate the information specified in Sub-paragraph 25.7 of these Regulations on the primary packaging of a cosmetic product or on the packaging in which the primary packaging is placed, it shall be specified in the annotation attached to the cosmetic product, on a label, a tape or a leaflet. In such case an indication regarding the addition of new information or the symbol specified in Annex 11 of these Regulations shall be given on the packaging of the cosmetic product in which the primary packaging is placed, but if there is none such – on the primary packaging.

40. If due to the size or shape of soaps, bath balls or other cosmetic products of small size it is impossible to provide the information specified in Sub-paragraph 25.7 of these Regulations


on an attached label, tape or leaflet, such information shall be displayed in an easily visible manner at the location of sale next to the cosmetic product offered for sale.

41. If the size of the relevant cosmetic product is small, the information provided for in Sub-paragraph 25.8 of these Regulations may be provided only on the packaging in which the primary packaging is placed.

42. If due to practical reasons it is not possible to indicate the information referred to in Sub-paragraph 25.9 of these Regulations on the primary packaging of a cosmetic product and on the packaging in which the primary packaging is placed, it shall be specified in the annotation attached to the cosmetic product, on a label, a tape or a leaflet. In such case an indication regarding the addition of new information or the symbol specified in Annex 11 of these Regulations shall be given on the primary packaging of a cosmetic product as well as on the packaging in which the primary packaging is placed.

43. The producer or importer of a cosmetic product may indicate on the packaging, in the labelling, in a notice, in the information attached to the cosmetic product, or in any other documentation or references regarding the cosmetic product that animals have not been utilised in the testing of the cosmetic product only in such cases where the manufacturer and suppliers of raw materials actually have not utilised animals for testing the final product, the prototype thereof or any ingredient thereof, as well as where they have not utilised any ingredients for the testing of which someone else has utilised animals in order to develop new cosmetic products.

44. In order to keep a commercial secret, the name of one or several ingredients may be omitted from the list of ingredients of the cosmetic product. In such case, the name of the ingredient shall be replaced on the list by the registration number of the ingredient, or by the patented name of the ingredient of the cosmetic product.

45. The registration number for the ingredients referred to in Paragraph 44 of these Regulations shall be assigned by the State Sanitary Inspection.

46. In order to receive permission for the keeping of a commercial secret and a registration number, the producer of a cosmetic product or the prime importer, if located in Latvia, shall hand in a submission to the State Sanitary Inspection prior to placing the cosmetic product on the market. The following information shall be specified in the submission:

46.1. the name and address of the producer or the prime importer, and the number of the registration certificate in the commercial register;

46.2. accurate identification of the ingredient for which the keeping of a commercial secret is being requested:

46.2.1. the CAS number, EINECS number, index number, chemical name of the colouring agent, IUPAC name, INCI name, the name in the European Pharmacopoeia, the international non-patented name recommended by the World Health Organisation and any other alternative international name if such exists;

46.2.2. the ELINCS name and number if such exists as well as information regarding the application of the ingredient for a registration number for the keeping of a commercial secret and the results of the review thereof if there is such; and

46.2.3. if the name or number referred to in Sub-paragraphs 46.2.1 and 46.2.2 of these Regulations does not exist (for example, for ingredients of natural origin), the


name of the basic material, the name of the part of the plant or animal utilised and names of the ingredient components, for example, solvents, shall be specified;46.3. the safety evaluation of the ingredient with regard to human health, taking into

consideration the general toxicological characteristics, chemical structure, level of exposure and utilisation of the ingredient in the particular cosmetic product, in conformity with Sub-paragraphs 58.4 and 58.5 of these Regulations;

46.4. types of cosmetic products in which the ingredient is intended to be used; 46.5. a detailed substantiation for keeping a commercial secret; 46.6. the name of the cosmetic product that will contain the ingredient applied for. If a

cosmetic product is to be placed on the market under various names, all trade names of the cosmetic product shall be indicated. If the name of the cosmetic product is not yet known, such information may be provided after the submission of the application, but not later than 15 days prior to the offering of the cosmetic product on the market. If an ingredient is utilised in several cosmetic products, one application which shall specify in which cosmetic products the ingredient will be used shall be sufficient; and

46.7. a notice regarding the application of the ingredient at the notified institutions of other Member States of the European Union as well as regarding the results of review thereof.

47. In the substantiation referred to in Sub-paragraph 46.5 of these Regulations one of the following conditions shall be specified, as appropriate:

47.1. information regarding the ingredient in the cosmetic product or the functions of such ingredient has not been described and is not known in the relevant field;

47.2. information regarding the ingredient is not publicly accessible, notwithstanding the fact that a patent application with regard to the ingredient or the use thereof has been submitted; or

47.3. if information regarding the ingredient were known, it could be easily imitated, thereby causing harm to the applicant.

48. The State Sanitary Inspection shall, within a time period of a month, perform an expert examination of the documents referred to in Paragraph 46 of these Regulations and shall inform the producer or the prime importer in writing regarding the decision taken. If additional information regarding the ingredient and the characteristics thereof is required, the examination period may be extended in accordance with the procedures laid down in the Administrative Procedure Law, but for a time period not exceeding six months, notifying the submitter thereof. In the decision regarding the results of the expert examination the name of the producer or the prime importer, the name of the ingredient, the name of the cosmetic product containing the stated ingredient, and the assigned registration number or the reasons for refusal shall be specified, indicating the procedures and time periods for the appeal of the decision.

49. The State Sanitary Inspection shall assign a registration number to the ingredient for a time period not exceeding five years. On the basis of the submission of the producer or the prime importer, the State Sanitary Inspection may take a decision regarding an extension of the term of validity of the registration number of the ingredient for a time period not exceeding three years. In such case the submission of the producer or the prime importer shall be reviewed in accordance with the procedures specified in Paragraph 48 of these Regulations.

50. The registration number of an ingredient shall consist of seven numbers: the first two – the year when the registration number was assigned, the next two – the State code assigned by the


European Commission corresponding to the registration for the keeping of a commercial secret regarding the ingredients of cosmetic products (before the code is assigned – 00), the last three – the symbol of the ingredient assigned by the State Sanitary Inspection.

51. The producer or the prime importer shall without delay, but not later than within a time period of 15 days, notify the State Sanitary Inspection regarding any changes in the information referred to in Paragraph 46 of these Regulations. The producer or the prime importer shall submit to the State Sanitary Inspection a report regarding the utilisation of such ingredient in any other cosmetic product not later than 15 days prior to the placing of the cosmetic product on the market. On the basis of the new information, particularly if such information is related to the safety evaluation of the ingredient, the State Sanitary Inspection may take a decision to withdraw the assigned registration number, notifying the producer or the prime importer regarding such refusal in accordance with the procedures specified in Paragraph 48 of these Regulations.

52. The State Sanitary Inspection shall ensure the preservation of the confidentiality of the information referred to in Paragraph 46 of these Regulations.

53. The State Sanitary Inspection shall, within a time period of a month, inform the European Commission and competent authorities of all Member States of the European Union:

53.1. regarding the issue of a permit for the keeping of a commercial secret regarding an ingredient, specifying the name, address of the producer or the prime importer, the name of the cosmetic products which contain the referred to ingredient, as well as the registration number assigned to the referred to ingredient; and

53.2. regarding the refusal to issue a permit for the keeping of the commercial secret regarding an ingredient or regarding the refusal to extend the term of validity of a permit for the keeping of a commercial secret, specifying the reasons therefor.

IV. Procedures for the Supervision of Compliance with the Essential Requirements of Cosmetic Products

54. Only such cosmetic product may be placed on the Latvian market which conforms with the requirements specified in these Regulations and which has been produced in compliance with the requirements of good manufacturing practice of cosmetic products laid down in Member States of the European Union.

55. An economic operator (commercial company) shall appoint a person responsible for the manufacture or first importation (the placing of a cosmetic product for the first time on the European Union market) of a cosmetic product.

56. The person responsible for the manufacture of a cosmetic product shall have at least a higher academic education or second-level vocational higher education and a relevant professional qualification (fifth-level professional qualification) in any of the following fields: medicine, pharmacology, chemistry, biology, food technology, food chemistry, which shall be attested by relevant documents.

57. The person responsible for the first import of a cosmetic product shall have at least first-level higher professional education (fourth-level professional qualification) in medicine, pharmacology, chemistry, biology, food technology or higher education in another similar


field as well as work experience of at least five years in the field of cosmetic products, which shall be attested by relevant documents.

58. The producer or the prime importer, if located in Latvia, shall ensure that, at the address of the undertaking specified on the labelling of a cosmetic product, the following information is freely accessible in Latvian (or in English, German, or Russian) for control purposes to the State Sanitary Inspection (within a time period of 72 hours after such has been requested):

58.1. the qualitative and quantitative composition of a cosmetic product, for perfume compositions – the name, code and manufacturing firm;

58.2. physico-chemical and microbiological specifications for the raw materials and finished product, as well as the purity and microbiological control criteria for the cosmetic product;

58.3. the manufacturing method of the cosmetic product which complies with the requirements of good manufacturing practice;

58.4. a safety evaluation of the cosmetic product with regard to human health, taking into account the general toxicological characteristics, chemical structure and level of exposure of ingredients. When determining the level of exposure, the specific exposure characteristics – the envisaged places of application or groups of users shall be taken into account. The safety of cosmetic products intended for children under three years of age and of cosmetic products that are intended only for external intimate hygiene must be particularly scrutinised. If one and the same product is manufactured at several production facilities of the relevant economic operator (commercial company) within the territory of the European Union, the producer of the cosmetic product may choose one of these at which such information shall be available. In such case the producer of the cosmetic product, if located in Latvia, shall notify the State Sanitary Inspection regarding the location (address) where the information referred to in this Sub-paragraph is kept;

58.5. the name, surname and address of the person responsible for the evaluation referred to in Sub-paragraph 58.4 of these Regulations. Such person shall have a diploma of higher education in pharmacology, toxicology, dermatology, medicine or another similar specialised field which has been recognised by the State in accordance with the procedures specified in regulatory enactments;

58.6. information regarding any undesirable effects of the cosmetic product upon human health, if such effects have manifested themselves after utilisation of the cosmetic product;

58.7. documentary evidence of any particular effects of the cosmetic product if in the labelling or advertising of the cosmetic product such characteristics or effects of the cosmetic product have been indicated; and

58.8. information regarding the use of animals in the testing of the cosmetic product or ingredients thereof carried out by the producer, a representative thereof or the supplier of raw materials in order to determine the safety of the cosmetic product as well as the conformity thereof with the requirements of the countries which are not Member States of the European Union.

59. If there is cause for suspicion that a cosmetic product does not comply with the requirements of these Regulations, the State Sanitary Inspection has the right to require that the producer of the cosmetic product or the prime importer, if located in Latvia, submits the results of the expert-examination of the information referred to in Paragraph 58 of these Regulations prepared by a competent accredited body. If the results of the expert-examination do not confirm the suspicions, the costs for the expert-examination shall be covered by the State Sanitary Inspection.


60. If, for control purposes, the State Sanitary Inspection requires the information referred to in Paragraph 58 of these Regulations regarding a cosmetic product the producer or prime importer of which is located in another Member State of the European Union, it shall request this information from the competent authority of the relevant Member State.

61. Prior to the placing of a cosmetic product on the Latvian market, the producer or the prime importer, if located in Latvia, shall notify the State Sanitary Inspection of the address of the place of production or first importation of the cosmetic product.

62. Prior to the placing of a cosmetic product on the Latvian market, the responsible person authorised by the producer and prime importer, if located in Latvia, as well as by the distributor in Latvia of a cosmetic product manufactured in another Member State of the European Union or first imported into another Member State of the European Union, shall submit to the State Sanitary Inspection the following information for the cosmetic products database:

62.1. regarding the undertaking and the responsible person – the producer, prime importer, distributor in Latvia of the cosmetic product and the responsible persons (Annex 12); and

62.2. regarding the cosmetic products placed on the Latvian market (including the qualitative and quantitative composition of the cosmetic products (Annex 13)).

63. The producer and prime importer, if located in Latvia, as well as the distributor in Latvia of the cosmetic product manufactured in another Member State of the European Union or first imported into another Member State of the European Union, shall without delay, but not later than five days after the receipt of any new information, inform the State Sanitary Inspection of any changes in the information referred to in Paragraph 62 of these Regulations.

64. The State Sanitary Inspection shall create and maintain the database of cosmetic products placed on the Latvian market referred to in Paragraph 62 of these Regulations.

65. The State Sanitary Inspection shall provide the information referred to in Paragraph 62 of these Regulations only upon request by medical treatment institutions for the provision of emergency medical care.

66. If, with regard to human health, the toxicological examination must be performed for the evaluation of the safety of a cosmetic product referred to in Sub-paragraph 58.4 of these Regulations, it shall be performed in conformity with the requirements of good laboratory practice in accordance with the procedures specified in the regulatory enactments specifying the requirements for the work quality of laboratories and for the inspecting of laboratories.

67. If there is strong evidence that a cosmetic product conformant with the requirements of these Regulations presents a threat to human health, the State Sanitary Inspection is entitled to temporarily prohibit the placing of such cosmetic product on the Latvian market or to establish special requirements thereupon. The State Sanitary Inspection shall without delay inform the European Commission as well as the competent authorities of other European Member States, indicating the basis for such decision.

68. The producer and the prime importer shall provide, also in electronic form, the information referred to in Sub-paragraphs 58.1 and 58.6 of these Regulations regarding


cosmetic products placed on the Latvian market which shall be readily accessible to the public. Information regarding the quantitative composition of a cosmetic product shall be provided for those ingredients (substances) which have been classified as substances which are dangerous to health (very toxic, toxic, harmful, irritant, sensitising, carcinogenic, mutagenic and toxic for the reproductive system) in accordance with regulatory enactments regulating the procedures for the classification, labelling and packaging of chemical substances and which are mentioned on the list of dangerous chemical substances approved by the Minister for Environment.

69. The control of compliance with these Regulations and supervision of the market of cosmetic products shall be performed by the State Sanitary Inspection.

70. The producer and the prime importer of a cosmetic product, if located in Latvia, as well as the distributor in Latvia of a cosmetic product which has been manufactured in another Member State of the European Union or which has been first imported into another Member State of the European Union shall be responsible for compliance with the requirements of these Regulations.

71. The producer or the prime importer may appeal the decisions taken by the State Sanitary Inspection in accordance with the procedures of the general administrative process.

V. Closing Provisions

72. These Regulations come into force on 1 May 2004.

73. Paragraph 18 of these Regulations comes into force on 11 March 2009, except for the requirements with regard to the use of animals in chronic toxicity, reproductive toxicity and toxicokinetic testing, which come into force on 11 March 2013.

74. Sub-paragraph 19.1 and Paragraph 68 of these Regulations come into force on 1 September 2004.

75. Sub-paragraph 19.2 of these Regulations comes into force on 11 March 2009.

76. The placing on the market of cosmetic products the labelling of which does not conform with the requirements specified in Paragraphs 30, 31 and 33 of these Regulations is permitted until 10 March 2005.

77. Cabinet Regulation No.226 of 5 June 2001, Safety Requirements and Procedures for Supervision of Cosmetic Products (Latvijas Vēstnesis, 2001, No.17) is repealed.

Informative Reference to European Union Directives

1. These Regulations contain legal provisions arising from Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products which is amended and supplemented by the following directives:

1.1. Council Directive 79/661/EEC of 24 July 1979,1.2. Commission Directive 82/147/EEC of 11 February 1982,


1.3. Council Directive 82/368/EEC of 17 May 1982,1.4. Commission Directive 83/191/EEC of 30 March 1983,1.5. Commission Directive 83/341/EEC of 29 June 1983,1.6. Commission Directive 83/496/EEC of 22 September 1983,1.7. Council Directive 83/574/EEC of 26 October 1983,1.8. Fifth Commission Directive 84/415/EEC of 18 July 1984,1.9. Sixth Commission Directive 85/391/EEC of 16 July 1985,1.10. Commission Directive 86/179/EEC of 22 September 1983,1.11. Eighth Commission Directive 86/199/EEC of 26 March 1986,1.12. Ninth Commission Directive 87/137/EEC of 2 February 1987,1.13. Tenth Commission Directive 88/233/EEC of 2 March 1988,1.14. Council Directive 88/667/EEC of 21 December 1988,1.15. Eleventh Commission Directive 89/174/EEC of 21 February 1989,1.16. Council Directive 89/679/EEC of 21 December 1989,1.17. Twelfth Commission Directive 90/121/EEC of 20 February 1990,1.18. Thirteenth Commission Directive 91/184/EEC of 12 March 1991,1.19. Fourteenth Commission Directive 92/8/EEC of 18 February 1992,1.20. Fifteenth Commission Directive 92/86/EEC of 21 October 1992,1.21. Council Directive 93/35/EEC of 14 June 1993,1.22. Sixteenth Commission Directive 93/47/EEC of 22 June 1993,1.23. Seventeenth Commission Directive 94/32/EC of 29 June 1994,1.24. Eighteenth Commission Directive 95/34/EC of 10 July 1995,1.25. Nineteenth Commission Directive 96/41/EC of 25 June 1996,1.26. Twentieth Commission Directive 97/1/EC of 10 January 1997,1.27. Twenty-first Commission Directive 97/45/EC of 14 July 1997,1.28. Twenty-second Commission Directive 98/16/EC of 5 March 1998,1.29. Commission Directive 98/62/EC of 3 September 1998,1.30. Twenty-fourth Commission Directive 2000/6/EC of 29 February 2000,1.31. Twenty-fifth Commission Directive 2000/11/EC of 10 March 2000,1.32. Twenty-sixth Commission Directive 2002/34/EC of 15 April 2002,1.33. Commission Directive 2003/1/EC of 6 January 2003,1.34. Commission Directive 2003/15/EC of 27 February 2003,1.35. Commission Directive 2003/16/EC of 19 February 2003,1.36. Commission Directive 2003/80/EC of 5 September 2003, and1.37. Commission Directive 2003/83/EC of 2003.

2. These Regulations contain legal norms arising from Commission Directive 95/17/EC of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic products.

Prime Minister I. Emsis

Minister for Health R. Muciņš


Annex 1Cabinet Regulation No. 354

20 April 2004

Basic Categories of Cosmetic Products

1. Creams, emulsions, lotions, gels, oils and similar skin care products (for face, hands, feet, and body).2. Face masks (with the exception of chemical peeling products).3. Anti-wrinkle products.4. Skin-whitening products.5. Face and eye make-up products (blushers, make-up powders, mascaras, eyeliners, eyebrow pencils, eye-shadows, eyebrow dye and other similar products).6. Powdered cosmetic products for skin care (make-up powders, after-bath powders, hygienic powders, baby powders, talcum and other similar products).7. Products for removing face and eye make-up.8. Cosmetic products for the lips.9. Nail care and decorating products and products for the removal thereof. 10. Cosmetic products for external intimate hygiene.11. Cosmetic products for tanning without sun. 12. Sunbathing products.13. Depilatories.14. Deodorants and anti-perspirants.15. Perfumes, perfumed waters, toilet waters and eau de Cologne.16. Hygiene products for the teeth and the oral cavity. 17. Hair care products:

17.1. hair dyes, hair tints and bleaches;17.2. products for the fixing and styling of hair (lacquers, mousses, gels, waxes,

lotions, brilliantines and other similar products); 17.3. products for hair washing and cleansing (lotions, powders, shampoos and other

similar products);17.4. products for hair conditioning (balsams, lotions, creams, oils and other similar

products); and17.5. products for the curling, straightening and fixing of hair.

18. Shaving products (creams, foams, lotions and other similar products).19. Soaps (toilet, baby, liquid, deodorant and other).20. Bath and shower preparations (salts, foams, oils, gels and other similar products).21. Tinted bases (powders, pastes, liquids and other similar products).




20 April 2004

Ingredients Prohibited in the Composition of Cosmetic Products

No.

Number in the Annex to Directive

76/768/EEC II

Name of ingredient

in Latvian In Latin and English

1. 2. b-acetoksietiltrimetilamonija hidroksīds (acetilholīns) un tāsāļi

b-Acetoxyethyltrimethyl ammonium hydroxide (acetylcholine) and its salts

2. 393. Acetonitrils Acetonitrile

3. 254. Acēnkumarols Acenocoumarol

4. 12. Akonitīns(zilo kurpīšu galvenais alkaloīds) un tā sāļi

Aconitine (principal alkaloid of Aconitum napellus L.) and its salts

5. 224. 2-(4-Allyl-2-methoxyphenoxy)-N-N-diethylacetamide and its salts

6. 18. Alilizotiocianāts Allyl isothiocyanate

7. 16. Alkīnu spirti, to esteri, ēteri un sāļi Alkyne alcohols, their esters, ethers and salts

8. 336. O-alkilditiokarbonskābjusāļi Salts of O-alkyldithiocarbonic acids

9. 19. Aloklamīdsun tā sāļi Alloclamide and its salts

10. 381. Amil 4-dimetilaminobenzoāts, izomēru maisījums (Padimāts A (INN))

Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN))

11. 247. Amilnitrīti Amyl nitrites

12. 29. 2-amino-1,2-bis(4-metoksifenil) etanols untā sāļi

2-Amino-1,2-bis(4-methoxyphenyl) ethanol and its salts

13. 412. 4-amino-2-nitrofenols 4-Amino-2-nitrophenol



16. 167. 4-aminobenzoskābes esteri ar brīvu aminogrupu, izņemot tos, kas minēti šo noteikumu 6.pielikumā

Esters of 4-aminobenzoic acid, with the free amino group, with the exception of that given in Annex VII, Part 2 of directive 76/768/EEC

17. 7. Aminokapronskābe un tās sāļi Aminocaproic acid and its salts

18. 31. 4-aminosalicilskābe un tās sāļi 4-Aminosalicylic acid and its salts

19. 146. Amitriptilīns un tā sāļi Amitriptyline and its salts

20. 106. Anamirtes augļi Anamirta cocculus L. (fruit)

21. 22. Anilīns, tā sāļiun tāhalogēnus un sēru saturošie atvasinājumi

Aniline, its salts and its halogenated and sulphonated derivatives

22. 390. Antiandrogēni ar steroīdu struktūru Anti-androgens of steroidal structure


No.Number in the

Annex to Directive

Name of ingredient


23. 39. Antibiotikas Antibiotics

24. 40. Antimons un tā savienojumi Antimony and its compounds

25. 38. Antracēneļļa Anthracene oil

26. 42. Apomorfīns(R 5,6,6a,7-tetrahidro-6-metil-4H-dibenzo [de,g]-hinolīn-10,11-diols)un tā sāļi

Apomorphine (R 5,6,6a,7-tetrahydro-6-methyl-4H-dibenzo [de,g]quinoline-10,11-diol) and its salts

27. 238. Arekolīns Arecoline

28. 365. Aristolohīnskābe un tās sāļi; aristolohiju sugas un to preparāti

Aristolochic acid and its salts; Aristolochia spp. and their preparations

29. 43. Arsēnsun tā savienojumi Arsenic and its compounds

30. 45. Atropīns, tā sāļiun atvasinājumi Atropine, its salts and derivatives

31. 286. Azaciklonolsun tā sāļi Azacyclonol and its salts

32. 423. Ālantes saknes eļļa, ja tā lietota kā smaržas sastāvdaļa (smaržviela)

Alanroot oil (Inula helenium) (CAS No 97676-35-2), when used as a fragrance ingredient

33. 76. Balanda, ambroziju (ēteriskā eļļa) Chenopodium ambrosioides (essential oil)

34. 345. Baltā zeltpīpenīte untāsgalēniskie preparāti

Pyrethrum album L. and its galenical preparations

35. 220. Barbiturāti Barbiturates

36. 46. Bārija sāļi, izņemot bārija sulfātu, bārija sulfīdu, kas norādīts šo noteikumu 3.pielikuma 1.punktā, un lakas, sāļus un pigmentus, kas iegūti no šo noteikumu 4.pielikumā minētajām krāsvielām ar atsauci (1)

Barium salts, with the exception of barium sulphate, barium sulphide under the conditions laid down in Annex III, Part 1 of directive 76/768/EEC, and lacquers, salts and pigments prepared from the colouring agents listed under reference(5) in Annex III, Part 2 and Annex IV, Part 2 of directive 76/768/EEC

37. 183. Bemegrīds un tā sāļi Bemegride and its salts

38. 157. Benaktizīns Benactyzine

39. 53. Bendroflumetiazīdsun tāatvasinājumi Bendroflumethiazide and its derivatives

40. 158. Benzatropīnsun tā sāļi Benzatropine and its salts

41. 49. Benzazepīni un benzodiazepīni Benzazepines and benzodiazepines

42. 26. Benzidīns Benzidine

43. 424. Benzilcianīds, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

Benzyl cyanide (CAS No 140-29-4), when used as a fragrance ingredient

44. 178. 4-benziloksifenols un 4-etoksifenols 4-Benzyloxyphenol and 4-ethoxyphenol

45. 60. Benzilonija bromīds Benzilonium bromide

46. 48. Benzimidazol-2(3H)-ons Benzimidazol-2(3H)-one

47. 47. Benzols Benzene

48. 54. Berīlijsun tā savienojumi Beryllium and its compounds


No.Number in the

Annex to Directive

Name of ingredient


49. 23. Betoksikaīnsun tā sāļi Betoxycaine and its salts

50. 287. Bietamiverīns Bietamiverine

51. 352. Bitionols Bithionol

52. 56. Bretilija tozilāts Bretylium tosilate

53. 59. Bromfeniramīnsun tā sāļi Brompheniramine and its salts

54. 58. Bromizovāls Bromisoval

55. 55. Broms,elementārais Bromine, elemental

56. 62. Brucīns Brucine

57. 90. Butanilikaīnsun tā sāļi Butanilicaine and its salts

58. 340. 4-terc-butilfenols 4-tert-Butylphenol

59. 108. 1-butil-3-(N-krotonoilsulfanilil) urīnviela

1-Butyl-3-(N-crotonoylsulphanilyl)urea

60. 414. 4-terc-butil-3-metoksi-2,6-dinitrotoluols (ambras muskuss)

4-tert-Butyl-3-methoxy-2,6-dinitrotoluene (Musk Ambrette)

61. 341. 4-terc-butilpirokatehols 4-tert-Butylpyrocatechol

62. 422. 5-terc-butil-1,2,3-trimetil-4,6-dinitrobenzols (muskuss tibetens)

5-tert-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (Musk tibetene)

63. 288. Butopiprīnsun tā sāļi Butopiprine and its salts

64. 75. Cefaelīnsun tā sāļi Cephaeline and its salts

65. 111. Ciānūdeņražskābe un tās sāļi Hydrogen cyanide and its salts

66. 425. Ciklameņu spirts, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

Cyclamen alcohol (CAS No 4756-19-8), when used as a fragrance ingredient

67. 122. Ciklarbamāts Cyclarbamate

68. 159. Ciklizīns un tā sāļi Cyclizine and its salts

69. 88. Ciklofosfamīdsun tā sāļi Cyclophosphamide and its salts

70. 112. 2-a-cikloheksilbenzil(N,N,N’,N’,-tetraetil) trimetilēndiamīns(fenetamīns)

2-a-Cyclohexylbenzyl (N,N,N’,N’,-tetraethyl) trimethylenediamine (phenetamine)

71. 113. Ciklomenolsun tā sāļi Cyclomenol and its salts

72. 8. Cinhofens, tā sāļi, atvasinājumiun šo atvasinājumu sāļi

Cinchophen, its salts, derivatives and salts of these derivatives

73. 129. Cinhokaīnsun tā sāļi Cinchocaine and its salts

74. 391. Cirkonijs un tā savienojumi, izņemot šo noteikumu 3.pielikumā minētos savienojumus un 4.pielikumā minētās cirkonija lakas, sāļus vai krāsvielu pigmentus

Zirconium and its compounds, with the exception of the substances listed under reference number 50 in Annex III, Part 1, and the zirconium lacquers, pigments or salts of the colouring agents listed with reference number 3 in Annex IV, Part 1 of directive 76/768/EEC


No.Number in the

Annex to Directive

Name of ingredient


75. 450. Citronverbēnas eļļa, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

Verbena oil (Lippia citriodora Kunth.) (CAS No 8024-12-2), when used as a fragrance ingredient

76. 15. Čūskveida rauvolfijas alkaloīdi un to sāļi

Rauwolfia serpentina alcaloids and their salts

77. 306. Dabiskās un sintētiskās narkotiskās vielas, kas ir minētas Ministru kabineta 1997.gada 14.janvāra noteikumu Nr.29 "Noteikumi par Labklājības ministrijas uzraudzībā esošo narkotisko vielu, psihotropo vielu un prekursoru sarakstiem" 1. un 2.pielikumā

Narcotics, natural and synthetic: All substances listed in tables I and II of the single Convention on narcotic drugs signed in NewYork on 30 March 1961

78. 3. Deanola aceglumāts Deanol aceglumate

79. 214. Dekametilēnbis (trimetilamonija) sāļi, piemēram, dekametonija bromīds

Decamethylenebis(trimethylammonium) salts, e.g. decamethonium bromide

80. 226. Dekstrometorfāns un tā sāļi Dextromethorphan and its salts

81. 116. Dekstropropoksifēns Dextropropoxyphene

82. 117. O,O’-diacetil-N-alil-N-normorfīns O,O’-Diacetyl-N-allyl-N-normorphine

83. 407. 2,4-diaminofeniletanols un tā sāļi 2,4-Diaminophenylethanol and its salts

84. 119. 5-(a, b-dibromfenetil)-5-metilhidantoīns 5-(a,b-Dibromophenethyl)-5-methylhydantoin

85. 351. Dibromsalicilanilīdi Dibromosalicylanilides

86. 128. 2-dietilaminoetil-3-hidroksi-4-fenilbenzoātsun tā sāļi

2-Diethylaminoethyl-3-hydroxy-4-phenylbenzoate and its salts

87. 130. 3-dietilaminopropilcinamāts 3-Diethylaminopropyl cinnamate

88. 426. Dietilmaleāts, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

Diethyl maleate (CAS No 141-05-9), when used as a fragrance ingredient

89. 170. Dietil 4-nitrofenilfosfāts Diethyl 4-nitrophenyl phosphate

90. 131. O,O’-dietil O-4-nitrofenilfosfortioāts (parations-ISO)

O,O’-Diethyl O-4-nitrophenyl phosphorothioate (parathion-ISO)

91. 339. Difenhidramīnsun tā sāļi Diphenhydramine and its salts

92. 434. Difenilamīns, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

Diphenylamine (CAS No 122-39-4), when used as a fragrance ingredient

93. 160. 5,5-difenil-4-imidazolidons 5,5-Diphenyl-4-imidazolidone

94. 154. Difenilpiralīnsun tā sāļi Diphenylpyraline and its salts

95. 270. Difenkloksazīns Difencloxazine

96. 80. Difenoksilāta hidrohlorīds Diphenoxylate hydrochloride

97. 134. Digitalīns un visi sarkanās uzpirkstītes heterozīdi

Digitaline and all heterosides of Digitalis purpurea L.


No.Number in the

Annex to Directive

Name of ingredient


98. 371. 2,2’-dihidroksi-3,3’,5,5’,6,6’-heksahlordifenilmetāns (heksahlorofēns)

2,2’-Dihydroxy-3,3’,5,5’,6,6’-hexachlorodiphenylmethane (Hexachlorophene)

99. 428. 2,4-dihidroksi-3-metilbenzaldehīds, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

2,4-dihydroxy-3-methylbenzaldehyde (CAS No 6248-20-0), when used as a fragrance ingredient

100. 207. 4,4’-dihidroksi-3,3’-(3-metiltiopropilidēn) dikumarīns

4,4’-Dihydroxy-3,3’-(3-methylthiopropylidene) dicoumarin

101. 427. Dihidrokumarīns, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

Dihydrocoumarine (CAS No 119-84-6), when used as a fragrance ingredient

102. 234. 3,4-dihidro-2-metoksi-2-metil-4-fenil-2H, 5H-pirano [3,2-c]-[1] benzopiran-5-ons (ciklokumarols)

3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano [3,2-c]-[1] benzopyran-5-one (cyclocoumarol)

103. 342. Dihidrotahisterols Dihydrotachysterol

104. 125. Dihloretāni(etilēnhlorīdi) Dichloroethanes (ethylene chlorides)

105. 126. Dihloretilēni(acetilēnhlorīdi) Dichloroethylenes (acetylene chlorides)

106. 36. 2,3-dihlor-2-metilbutāns 2,3-Dichloro-2-methylbutane

107. 349. Dihlorsalicilanilīdi Dichlorosalicylanilides

108. 361. 5,5’-di-izopropil-2,2’-dimetilbifenil-4,4’-diil dihipojodīts

5,5’-Di-isopropyl-2,2’-dimethylbiphenyl-4,4’-diyl dihypoiodite

109. 231. Dikumarols Dicoumarol

110. 50. 1-dimetilaminometil-1-metilpropilbenzoāts(amilokaīns) un tā sāļi

1-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and its salts

111. 143. 1,1-bis (dimetilaminometil) propilbenzoāts (amidrikaīns, alipīns) un tā sāļi

1,1-Bis(dimethylaminomethyl)propyl benzoate (amydricaine, alypine) and its salts

112. 142. Dimetilamīns Dimethylamine

113. 431. Dimetilcitrakonāts, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

Dimethyl citraconate (CAS No 617-54-9), when used as a fragrance ingredient

114. 368. 2,6-dimetil-1,3-dioksān-4-il acetāts (dimetoksāns)

2,6-Dimethyl-1,3-dioxan-4-yl acetate (Dimethoxane)

115. 432. 7,11-dimetil-4,6,10-dodekatriēn-3-ons, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

7,11-Dimethyl-4,6,10-dodecatrien-3-one (CAS No 26651-96-7), when used as a fragrance ingredient

116. 355. Dimetilformamīds Dimethylformamide

117. 429. 3,7-dimetil-2-oktēn-1-ols (6,7-dihidrogeraniols), ja to lieto kā smaržas sastāvdaļu (smaržvielu)

3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol) (CAS No 40607-48-5), when used as a fragrance ingredient

118. 30. 1,3-dimetilpentilamīns un tā sāļi 1,3-dimethylpentylamine and its salts

119. 338. Dimetilsulfoksīds Dimethyl sulfoxide


No.Number in the

Annex to Directive

Name of ingredient


120. 430. 4,6-dimetil-8-terc-butilkumarīns, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

4,6-Dimethyl-8-tert-butylcoumarin (CAS No 17874-34-9), when used as a fragrance ingredient

121. 433. 6,10-dimetil-3,5,9-undekatriēn-2-ons, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

6,10-Dimethyl-3,5,9-undecatrien-2-one (CAS No 141-10-6), when used as a fragrance ingredient

122. 153. Dimevamīds un tā sāļi Dimevamide and its salts

123. 151. Dinitrofenola izomēri Dinitrophenol isomers

124. 343. Dioksāns Dioxane

125. 136. Dioksetedrīns un tā sāļi Dioxethedrin and its salts

126. 162. Disulfirāms (tirams-ISO) Disulfiram; thiram (ISO)

127. 396. Ditio-2,2’-bispiridīndioksīds 1,1’ (piedeva ar magnija trihidrosulfātu) - (piritiona disulfīds + magnija sulfāts)

Dithio-2,2’-bispyridine-dioxide 1,1’ (additive with trihydrated magnesium sulphate) - (pyrithione disulphide + magnesium sulphate)

128. 359. Dižā laura sēklu eļļa Oil from the seeds of Laurus nobilis L.

129. 176. Doksilamīns un tā sāļi Doxylamine and its salts

130. 301. Dzeloņainais (parastais) velnābols untāgalēniskie preparāti

Datura stramonium L. and its galenical preparations

131. 221. Dzīvsudrabs un tā savienojumi, izņemot šo noteikumu 5.pielikumā minētās vielas

Mercury and its compounds, except those those special cases included in Annex VI, Part 1 of directive 76/768/EEC

132. 164. Efedrīns un tā sāļi Ephedrine and its salts

133. 163. Emetīns, tā sāļi un atvasinājumi Emetine, its salts and derivatives

134. 14. Epinefrīns Epinephrine

135. 400. 1,2-epoksibutāns 1,2-Epoxybutane

136. 335. Ergokalciferols un holekalciferols (D2

un D3 vitamīni)Ergocalciferol and cholecalciferol (vitamins D2 and D3)

137. 260. Estrogēni Oestrogens

138. 435. Etilakrilāts, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

Ethyl acrylate (CAS No 140-88-5), when used as a fragrance ingredient

139. 204. Etil bis(4-hidroksi-2-okso-1-benzopiran-3-il) acetāts un atbilstošās skābes sāļi

Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl) acetate and salts of the acid

140. 182. Etilēnoksīds Ethylene oxide

141. 272. Etilfenacemīds Ethylphenacemide

142. 362. 3’-etil-5’,6’,7’,8’-tetrahidro-5’,5’,8’,8’-tetrametil-2’-acetilnaftons vai 7-acetil-6-etil-1,1,4,4-tetrametil-1,2,3,4 tetrahidronaftalīns

3’-Ethyl-5’,6’,7’,8’-tetrahydro-5’,5’,8’,8’-tetramethyl-2’-acetonaphthone or 7-acetyl-6-ethyl-1,1,4,4-tetramethyl-1,2,3,4-tetrahydronaphthalen

143. 319. Etionamīds Ethionamide


No.Number in the

Annex to Directive

Name of ingredient


144. 173. Etoheptazīns un tā sāļi Ethoheptazine and its salts

145. 406. 4-etoksi-m-fenilēndiamīns un tā sāļi 4-Ethoxy-m-phenylenediamine and its salts

146. 166. Ezerīns jeb fizostigmīns un tā sāļi Eserine or physostigmine and its salts

147. 269. Fenacemīds Phenacemide

148. 208. Fenadiazols Fenadiazole

149. 81. 4-fenilazofenilēn-1,3-diamīna citrāta hidrohlorīds(hrizoidīna citrāta hidrohlorīds)

4-Phenylazophenylene-1,3-diamine citrate hydrochloride (chrysoidine citrate hydrochloride)

150. 67. Fenilbutazons Phenylbutazone

151. 356. 4-fenilbut-3-ēn-2-ons 4-Phenylbut-3-en-2-one

152. 363. O-fenilēndiamīns un tā sāļi O-Phenylenediamine and its salts

153. 271. 2-fenilindān-1,3-dions (fenindions) 2-Phenylindane-1,3-dione (phenindione)

154. 274. Feniramidols Fenyramidol

155. 232. Fenmetrazīns,tāatvasinājumiun sāļi Phenmetrazine, its derivatives and salts

156. 320. Fenotiazīnsun tā savienojumi Phenothiazine and its compounds

157. 180. Fenozolons Fenozolone

158. 71. Fenprobamāts Phenprobamate

159. 273. Fenprokumons Phenprocoumon

160. 374. Fitolaku sugas un to preparāti Phytolacca spp. and its preparations

161. 187. Fluanizons Fluanisone

162. 189. Fluorezons Fluoresone

163. 190. Fluoruracils Fluorouracil

164. 191. Fluorūdeņražskābe, tās normālie sāļi, kompleksie savienojumi un fluorūdeņraži, izņemot šo noteikumu 3.pielikumā minētos

Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex III, Part 1 of directive 76/768/EEC

165. 279. Fosfors un metālu fosfīdi Phosphorus and metal phosphides

166. 252. Furazolidons Furazolidone

167. 192. Furfuriltrimetilamonija sāļi, piemēram, furtretonija jodīds

Furfuryltrimethylammonium salts, e.g. furtrethonium iodide

168. 358. Furokumarīni (piemēram, trioksisalāns, 8-metoksipsora-lēns, 5-metoksipsoralēns), izņemot normālu koncentrāciju dabīgās esencēs.

Kosmētikas līdzekļos, kuri paredzēti aizsardzībai pret sauli, un sauļošanās līdzekļos furokumarīnu koncentrācija nedrīkst pārsniegt 1 mg/kg

Furocoumarines (e.g. trioxysalan, 8-methoxypsoralen, 5-methoxy-psoralen) except for normal content in natural essences used.

In sun protection and in bronzing products, furocoumarines shall be below 1 mg/kg

169. 329. Galamīna trietjodīds Gallamine triethiodide


No.Number in the

Annex to Directive

Name of ingredient


170. 193. Galantamīns Galantamine

171. 100. Gliciklamīds Glycyclamide

172. 300. Glikokortikoīdi Glucocorticoids

173. 181. Glutetimīds un tā sāļi Glutethimide and its salts

174. 259. Guanetidīns un tā sāļi Guanethidine and its salts

175. 230. Gvajofenezīns Guaifenesin

176. 185. Haloperidols Haloperidol

177. 316. Heksaetiltetrafosfāts Hexaethyl tetraphosphate

178. 70. (1R,25)-heksahidro-1,2-dimetil-3,6-epoksiftalanhidrīds (kantaridīns)

(1R,25)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (cantharidin)

179. 198. (1R,4S,5R,8S)-1,2,3,4,10,10-heksahlor-1,4,4a,5,8,8a-heksahidro-1,4:5,8-dimetānnaftalīns (izodrīns-ISO)

(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethano-naphthalene (isodrin-ISO)

180. 196. (1R,4S,5R,8S)-1,2,3,4,10,10-heksahlor-6,7-epoksi-1,4,4a,5,6,7,8,8a-oktahidro-1,4:5,8-dimetānnaftalīns (endrīns-ISO)

(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4:5,8-dimethano-naphthalene (endrin-ISO)

181. 195. 1,2,3,4,5,6-heksahlorciklo-heksāns (BHC-ISO)

1,2,3,4,5,6-Hexachlorocyclo-hexane (BHC-ISO)

182. 197. Heksahloretāns Hexachloroethane

183. 124. N,N’-heksametilēnbis (trimetilamonija) sāļi, piemēram, heksametonija bromīds

N,N’-Hexamethylenebis (trimethylammonium) salts, e.g. hexamethonium bromide

184. 115. Heksapropimāts Hexapropymate

185. 438. Trans-2-heksenāldietilacetāls, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

trans-2-Hexenal diethyl acetal (CAS No 67746-30-9), when used as a fragrance ingredient

186. 439. Trans-2-heksenāldimetil-acetāls, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

trans-2-Hexenal dimethyl acetal (CAS No 18318-83-7), when used as a fragrance ingredient

187. 437. Trans-2-heptenāls, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

trans-2-Heptenal (CAS No 18829-55-5), when used as a fragrance ingredient

188. 199. Hidrastīns, hidrastinīns un tosāļi Hydrastine, hydrastinine and their salts

189. 200. Hidrazīdi un to sāļi Hydrazides and their salts

190. 201. Hidrazīns, tā atvasinājumiun tosāļi Hydrazine, its derivatives and their salts

191. 440. Hidroabietilspirts, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

Hydroabietyl alcohol (CAS No 13393-93-6), when used as a fragrance ingredient

192. 417. 3,3-bis(4-hidroksifenil) ftalīds (fenolftaleīns)

3,3-Bis(4-hydroxyphenyl) phthalide (Phenolphthalein)


No.Number in the

Annex to Directive

Name of ingredient


193. 135. 7-[2-hidroksi-3-(2-hidroksietil-N-metilamino) propil] teofilīns (ksantinols)

7-[2-Hydroxy-3-(2-hydroxyethyl-N-ethylamino)propyl]theophylline (xanthinol)

194. 395. Hidroksi-8-hinolīns un tā sulfāts (izņemot lietošanai saskaņā ar šo noteikumu 3.pielikumu)

Hydroxy-8-quinoline and its sulphate, except for the uses provided for in No 51 in Annex III, Part 1 of directive 76/768/EEC

195. 5. [4-(4-hidroksi-3-jodofenoksi)-3,5-dijodofenil] etiķskābe un tās sāļi

[4-(4-Hydroxy-3-iodophenoxy)-3,5-diodophenyl]acetic acid and its salts

196. 357. 4-hidroksi-3-metoksikanēļspirta benzoāti, izņemot normālu koncentrāciju dabīgajās esencēs

Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol except for normal content in natural essences used

197. 240. Hidroksizīns Hydroxyzine

198. 210. Hiosciamīns, tāsāļi un atvasinājumi Hyoscyamine, its salts and derivatives

199. 295. Hioscīns, tāsāļi un atvasinājumi Hyoscine, its salts and derivatives

200. 1. N-5-hlorbenzoksazol-2-ilacetamīds N-5-Chlorobenzoxazol-2-ylacetamide

201. 96. Hloretāns Chloroethane

202. 86. N,N-bis (2-hloretil) metilamīnN-oksīdsun tā sāļi

N,N-bis(2-chloroethyl)methylamine N-oxide and its salts

203. 93. 2-[2-(4-hlorfenil)-2-fenilacetil]indān 1,3-dions (hlorfacinons-ISO)

2-[2-(4-Chlorophenyl)-2-phenylacetyl]indan 1,3-dione (chlorophacinone-ISO)

204. 95. 2-[2-(4-hlorfenil)-2-fenilacetil]indān 1,3-dions (hlorfacinons-ISO)

2-[2-(4-Chlorophenyl)-2-phenylacetyl]indan 1,3-dione (chlorophacinone-ISO)

205. 94. Hlorfenoksamīns Chlorphenoxamine

206. 83. 2-hlor-6-metilpirimidīn-4-ildi-metilamīns (krimidīns-ISO)

2-Chloro-6-methylpyrimidin-4-yldimethylamine (crimidine-ISO)

207. 87. Hlormetīnsun tā sāļi Chlormethine and its salts

208. 91. Hlormezanons Chlormezanone

209. 366. Hloroforms Chloroform

210. 79. Hlorpropamīds Chlorpropamide

211. 84. Hlorprotiksēnsun tā sāļi Chlorprothixene and its salts

212. 78. Hlors Chlorine

213. 262. Hlortalidons Chlortalidone

214. 82. Hlorzoksazons Chlorzoxazone

215. 168. Holīna sāļi un to esteri, piemēram, holīna hlorīds

Choline salts and their esters, e.g. choline chloride

216. 97. Hroms, hromskābe un tās sāļi Chromium, chromic acid and its salts

217. 385. 11-a-hidroksipregn-4-ēn-3,20-dions un tā esteri

11a-Hydroxypregn-4-ene-3,20-dione and its esters


No.Number in the

Annex to Directive

Name of ingredient


218. 418. 3-imidazol-4-ilakrilskābe un tās etilesteris (urokānskābe)

3-Imidazol-4-ylacrylic acid and its ethyl ester (urocanic acid)

219. 34. Imperatorīn (9-(3-metoksilbut-2-eniloksi) furo [3,2-g] hroma-7-ons)

Imperatorin (9-(3-methoxylbut-2-enyloxy)furo[3,2-g]chromen-7-one)

220. 281. Indīgā fizostigma Physostigma venenosum Balf.

221. 152. Inprokvons Inproquone

222. 215. Ipekakuāna un radniecīgās sugas (saknes, pulveris un galēniskie preparāti)

Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations)

223. 52. Izokarboksazīds Isocarboxazide

224. 228. Izometheptēns un tā sāļi Isometheptene and its salts

225. 17. Izoprenalīns Isoprenaline

226. 441. 6-izopropil-2-dekahidro-naftalinols, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

6-Isopropyl-2-decahydro-naphthalenol (CAS No 34131-99-2), when used as a fragrance ingredient

227. 216. (2-izopropilpent-4-enoil) urīnviela(apronalīds)

(2-Isopropylpent-4-enoyl) urea (apronalide)

228. 148. Izosorbīda dinitrāts Isosorbide dinitrate

229. 419. Īpašie riska materiāli un no tiem iegūtās sastāvdaļas, kas norādīti Eiropas Parlamenta un Padomes Regulas (EK) Nr.999/2001 V pielikumā, – pēc minētās Regulas 22.panta 1.daļā noteiktā datuma. Regulas (EK) Nr.999/2001 XI pielikuma A nodaļā norādītos īpašos riska materiālus un no tiem iegūtās sastāvdaļas, – līdz minētās Regulas 22.panta 1.daļā noteiktajam datumam.

Izņemot šo riska materiālu tauku atvasinājumus, ko var lietot, ja to ražošanai tiek izmantotas šādas metodes, ko ir apliecinājis to ražotājs:

- transesterifikācija vai hidrolīze vismaz pie 200 °C un atbilstoša spiediena 20 minūtes (glicerīns, taukskābes un tauskābju esteri);

- pārziepošana ar 12M NaOH (glicerīns un ziepes):

- ražojot partijās: trīs stundas pie 95 °C

vai

- nepārtrauktā procesā: astoņas minūtes pie 140 °C, diviem bāriem (2000 hPa) vai līdzīgos apstākļos

From the date referred to in Article 22(1) of Regulation (EC) No 999/2001 of the European Parliament and of the Council (OJ L 147, 31.5.2001, p. 1), the specified risk materials as designated in Annex V to that Regulation, and ingredients derived therefrom.

Until that date, the specified risk materials as designated in Annex XI Part A to Regulation (EC) No 999/2001, and ingredients derived therefrom.

However, tallow derivatives may be used provided that the following methods have been used and strictly certified by the producer:

- Transesterification or hydrolysis at at least: 200 °C and at an appropriate corresponding pressure, for 20 minutes (glycerol, fatty acids and fatty acids esters;

- Saponification with NaOH 12M (glycerol and soap):

- Batch process: at 95 °C for three hours

or

- Continuous process: at 140 °C, two bars (2000 hPa) for eight minutes or equivalent conditions

230. 213. Jods Iodine


No.Number in the

Annex to Directive

Name of ingredient


231. 337. Johimbīns un tā sāļi Yohimbine and its salts

232. 68. Kadmijs un tā savienojumi Cadmium and its compounds

233. 41. Kaņepju kendira untāspreparāti Apocynum cannabinum L. and its preparations

234. 140. Kaptodiāms Captodiame

235. 169. Karamifēns un tā sāļi Caramiphen and its salts

236. 72. Karbazola nitroatvasinājumi Nitroderivatives of carbazol

237. 156. N-(3-karbamoil-3,3-difenilpropil)-N,N-diizopropilmetilamonija sāļi, piemēram, izopropamīda jodīds

N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethylammonium salts, e.g. isopropamide iodide

238. 57. Karbromāls Carbromal

239. 66. Karbutamīds Carbutamide

240. 235. Karisoprodols Carisoprodol

241. 74. Katalāze Catalase

242. 408. Katehols Catechol

243. 294. Kazaku kadiķa lapas, ēteriskāeļļaun galēniskie preparāti

Juniperus sabina L. (leaves, essential oil and galenical preparations)

244. 85. Klofenamīds Clofenamide

245. 123. Klofenotāns,DDT (ISO) Clofenotane DDT (ISO)

246. 101. Kobalta benzosulfonāts Cobalt benzenesulphonate

247. 102. Kolhicīns,tāsāļi un atvasinājumi Colchicine, its salts and derivatives

248. 103. Kolhikozīdsun tāatvasinājumi Colchicoside and its derivatives

249. 290. Koniīns Coniine

250. 105. Konvalatoksīns Convallatoxin

251. 397. Krāsviela CI 12075, tās lakas, pigmenti un sāļi

Colouring agent CI 12075 and its lacquers, pigments and salts

252. 378. Krāsviela CI 12140 Colouring agent CI 12140





257. 380. Krāsviela CI 42555

Krāsviela CI 42555-1

Krāsviela CI 42555-2

Colouring agent CI 42555

Colouring agent CI 42555-1

Colouring agent CI 42555-2




No.Number in the

Annex to Directive

Name of ingredient


260. 398. Krāsvielas CI 45170 un

CI 45170:1

Colouring agent CI 45170 and

CI 45170:1

261. 107. Krotona eļļa Croton tiglium (oil)

262. 33. Ksilidīni,toizomēri,sāļi un tā halogēnus un sēru saturošie atvasinājumi

Xylidines, their isomers, salts and halogenated and sulphonated derivatives

263. 313. Ksilometazolīns un tā sāļi Xylometazoline and its salts

264. 225. Kumetarols Coumetarol

265. 109. Kurāre un kurarīns Curare and curarine

266. 291. Laurķirši ("Laurķiršu ūdens") Prunus laurocerasus L. ("cherry laurel water")

267. 399. Lidokaīns Lidocaine

268. 35. Lielā ammija un tās galēniskie preparāti Ammi majus and its galenical preparations

269. 127. Lizergīds un tā sāļi Lysergide and its salts

270. 219. Lobelīns un tā sāļi Lobeline and its salts

271. 149. Malononitrils Malononitrile

272. 89. Mannomustīnsun tā sāļi Mannomustine and its salts

273. 141. Mefeklorazīnsun tā sāļi Mefeclorazine and its salts

274. 322. Mefenezīnsun tā esteri Mephenesin and its esters

275. 229. Mekamilamīns Mecamylamine

276. 298. Melnā naktene untāsgalēniskie preparāti Solanum nigrum L. and its galenical preparations

277. 211. Melnās driģenes lapas, sēklas, pulveris un galēniskie preparāti

Hyosciamus niger L. (leaves, seeds, powder and galenical preparations)

278. 44. Melnā velnoga un tās preparāti Atropa belladonna L. and its preparations

279. 98. Melnie graudi, toalkaloīdiun galēniskie preparāti

Claviceps purpurea Tul., its alkaloids and galenical preparations

280. 236. ; Meprobamate

281. 223. Metaldehīds Metaldehyde

282. 145. Metamfepramonsun tā sāļi Metamfepramone and its salts

283. 144. Metapirilēnsun tā sāļi Methapyrilene and its salts

284. 171. Metetoheptazīns un tā sāļi Metethoheptazine and its salts

285. 147. Metformīns un tā sāļi Metformin and its salts

286. 174. Metheptazīns un tā sāļi Metheptazine and its salts

287. 445. Metil-trans-2-butenoāts, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

Methyl trans-2-butenoate (CAS No 623-43-8), when used as a fragrance ingredient


No.Number in the

Annex to Directive

Name of ingredient


288. 451. Metileigenols, izņemot normālā koncentrācijā dabīgajās esencēs, ja koncentrācija nepārsniedz:

a) 0,01 % smaržās

b) 0,004 % tualetes ūdenī

c) 0,002 % smaržkrēmā

d) 0,001 % līdzekļos, kurus noskalo

e) 0,0002 % līdzekļos, kurus nenoskalo un mutes dobuma higiēnas līdzekļos

Methyleugenol (CAS No 95-15-2) except for normal content in the natural essences and provided that the concentration does not exceed:

a) 0,01 % in fine fragrance

b) 0,004 % in eau de toilette

c) 0,002 % in fragrance cream

d) 0,001 % in rinse-off products

e) 0,0002 % in other leave-on products and oral hygiene products

289. 175. Metilfenidātsun tā sāļi Methylphenidate and its salts

290. 413. 2-metil-m-fenilēndiamīns 2-Methyl-m-phenylenediamine

291. 364. 4-metil-m-fenilēndiamīns un tā sāļi 4-Methyl-m-phenylenediamine and its salts

292. 447. 5-metil-2,3-heksāndions, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

5-Methyl-2,3-hexanedione (CAS No 13706-86-0), when used as a fragrance ingredient

293. 227. 2-metilheptilamīns un tā sāļi 2-Methylheptylamine and its salts

294. 121. N,N’-[(metilimino) dietilēn] bis(etildimetilamonija)sāļi, piemēram,azametonija bromīds

N,N’-[(Methylimino)diethylene] bis(ethyldimethylammonium) salts, e.g. azamethonium bromide

295. 446. 7-metilkumarīns, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

7-Methylcoumarin (CAS No 2445-83-2), when used as a fragrance ingredient

296. 133. Metiprilonsun tā sāļi Methyprylon and its salts

297. 292. Metirapons Metyrapone

298. 205. Metokarbamols Methocarbamol

299. 346. 2-[4-metoksibenzil-N-(2-piridil) amino] etildimetilamīna maleāts

2-[4-Methoxybenzyl-N-(2-pyridyl) amino]ethyldimethylamine maleate

300. 376. 1-metoksi-2,4-diaminobenzols (2,4-diaminoanizols) un tā sāļi

1-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole) and their salts

301. 377. 1-metoksi-2,5-diaminobenzols (2,5-diaminoanizols) un tā sāļi

1-Methoxy-2,5-diaminobenzene (2,5-diaminoanisole) and their salts

302. 443. 4-(4-metoksifenil)-3-butēn-2-ons, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

4-(4-Methoxyphenyl)-3-butene-2-one (CAS No 943-88-4), when used as a fragrance ingredient

303. 444. 1-(4-metoksifenil)-1-pentēn-3-ons, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

1-(4-Methoxyphenyl)-1-penten-3-one (CAS No 104-27-8), when used as a fragrance ingredient

304. 442. 7-metoksikumarīns, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

7-Methoxycoumarin (CAS No 531-59-9), when used as a fragrance ingredient

305. 6. Metotreksāts Methotrexate

306. 69. Mīkstspārņu dzimta, zaļā eļļas vabole ("spāņu muša")

Cantharides, Cantharis vesicatoria


No.Number in the

Annex to Directive

Name of ingredient


307. 64. Mofebutazons Mofebutazone

308. 344. Morfolīns un tā sāļi Morpholine and its salts

309. 244. Nafazolīns un tā sāļi Naphazoline and its salts

310. 243. 3-(1-naftil)-4-hidroksikumarīns 3-(1-Naphthyl)-4-hydroxycoumarin

311. 242. 1- un 2-naftilamīni un to sāļi 1- and 2-Naphthylamines and their salts

312. 241. 2-naftols 2-Naphthol

313. 20. Nalorfīns, tā sāļiun ēteri Nalorphine, its salts and ethers

314. 114. Nātrijaheksaciklonāts Sodium hexacyclonate

315. 369. Nātrija piritions (INNM) Pyrithione sodium (INNM)

316. 420. Neattīrītā un attīrītā akmeņogļu darva Crude and refined coal tars

317. 309. Neodīmsun tā sāļi Neodymium and its salts

318. 248. Neorganiskie nitrīti, izņemot nātrija nitrītu

Inorganic nitrites, with the exception of sodium nitrite

319. 245. Neostigmīns un tā sāļi (piemēram, neostigmīna bromīds)

Neostigmine and its salts (e.g. neostigmine bromide)

320. 246. Nikotīns un tā sāļi Nicotine and its salts

321. 249. Nitrobenzols Nitrobenzene

322. 251. Nitrofurantoīns Nitrofurantoin

323. 250. Nitrokrezoli un to sārmu metālu sāļi Nitrocresols and their alkali metal salts

324. 209. Nitroksolīns un tā sāļi Nitroxoline and its salts

325. 256. Nitrostilbēni, to homologi un atvasinājumi

Nitrostilbenes, their homologues and their derivatives

326. 410. Nitrozamīni (nitrozoamīni) Nitrosamines

327. 257. Noradrenalīns un tā sāļi Noradrenaline and its salts

328. 258. Noskapīns un tā sāļi Noscapine and its salts

329. 73. Oglekļa disulfīds Carbon disulphide

330. 132. [Oksalilbisiminoetilēn]bis[(o-hlorbenzil) dietilamonija sāļi], piemēram, ambenomija hlorīds

[Oxalylbisiminoethylene]bis[(o-chlorobenzyl)diethylammonium salts], e.g. ambenomium chloride

331. 165. Oksanamīds un tā atvasinājumi Oxanamide and its derivatives

332. 172. Oksfeneridīns un tā sāļi Oxpheneridine and its salts

333. 267. Oktamilamīns un tā sāļi Octamylamine and its salts

334. 202. Oktamoksīnsun tā sāļi Octamoxin and its salts

335. 28. Oktodrīnsun tā sāļi Octodrine and its salts

336. 261. Oleandrīns Oleandrin

337. 411. Otrējie alkil- un alkanolamīni un to sāļi Secondary alkyl- and alkanolamines and their salts


No.Number in the

Annex to Directive

Name of ingredient


338. 186. Parametazons Paramethasone

339. 179. Paretoksikaīns un tā sāļi Parethoxycaine and its salts

340. 13. Pavasara adoniss un tā preparāti Adonis vernalis L. and its preparations

341. 263. Pelleterīnsun tā sāļi Pelletierine and its salts

342. 212. Pemolīns un tā sāļi Pemoline and its salts

343. 265. Pentaeritritiltetranitrāts Pentaerithrityl tetranitrate

344. 264. Pentahloretāns Pentachloroethane

345. 421. 1,1,3,3,5-pentametil-4,6-dinitroindāns (moskens)

1,1,3,3,5-Pentamethyl-4,6-dinitroindane (moskene)

346. 120. N,N’-pentametilēnbis (trimetilamonija) sāļi, piemēram, pentametonija bromīds

N,N’-Pentamethylenebis (trimethylammonium salts), e.g. pentamethonium bromide

347. 448. 2-pentilidēncikloheksanons, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

2-Pentylidenecyklohexanone (CAS No 25677-40-1), when used as a fragrance ingredient

348. 266. Petrihlorāls Petrichloral

349. 268. Pikrīnskābe Picric acid

350. 282. Pikrotoksīns Picrotoxin

351. 283. Pilokarpīns un tā sāļi Pilocarpine and its salts

352. 311. Pilokarpsun tāgalēniskie preparāti Pilocarpus jaborandi Holmes and its galenical preparations

353. 118. Pipazetātsun tā sāļi Pipazetate and its salts

354. 372. 6-(piperidinil)-2,4-pirimidīndiamīn-3-oksīds (minoksidils) un tā sāļi

6-(Piperidinyl)-2,4-pyrimidinediamine-3-oxide (Minoxidil) and its salts

355. 284. a-piperidīn-2-ilbenzilacetāta levorotatoritreoforms (levofacetoperāns)un tā sāļi

a-piperidin-2-ylbenzyl acetate laevorotatory threoform (levophacetoperane) and its salts

356. 285. Pipradrols un tā sāļi Pipradrol and its salts

357. 137. Piprokurārijs Piprocurarium

358. 99. Plankumainā suņstobra augļi, pulveris, galēniskie preparāti

Conium maculatum L. fruit, powder, galenical preparations

359. 409. Pirogallols Pyrogallol

360. 239. Poldīna metilsulfāts Poldine methylsulfate

361. 405. Pramokaīns Pramocaine

362. 161. Probenecīds Probenecid

363. 194. Progestogēni Progestogens

364. 25. Prokaīnamīds,tā sāļiun atvasinājumi Procainamide, its salts and derivatives

365. 206. Propatilnitrāts Propatylnitrate


No.Number in the

Annex to Directive

Name of ingredient


366. 253. Propāna 1,2,3-triil trinitrāts Propane-1,2,3-triyl trinitrate

367. 138. Propifenazons Propyphenazone

368. 278. Psilocibīns Psilocybine

369. 293. Radioaktīvāsvielas saskaņā ar definīciju Direktīvā 96/29/Euratom, ar ko nosaka drošuma pamatnormatīvus strādājošo un visas sabiedrības veselības aizsardzībai pret risku, ko rada jonizējošais starojums

Radioactive substances, as defined by Directive 96/29/Euratom (OJ L 159, 29.6.1996, p.1) laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation

370. 104. Rudens vēlziede untāsgalēniskie preparāti

Colchicum autumnale L. and its galenical preparations

371. 360. Safrols, izņemot normālu koncentrāciju dabīgajās esencēs, ja koncentrācija nepārsniedz:

- 0,01 % galaproduktā,

- 0,005 % mutes un zobu kopšanas līdzekļos. Safrolu aizliegts lietot bērnu zobu pastās

Safrole except for normal content in the natural essences used and provided the concentration does not exceed:

- 100 ppm in the finished product,

- 50 ppm in products for dental and oral hygiene, and provided that Safrole is not present in toothpastes intended specifically for children

372. 217. a-santonīns

[(3S,5aR,9bS)-3,3a,4,5,5a,9b-heksahidro-3,5a,9-trimetilnafto [1,2-b] furan-2,8-dions]

a-Santonin

[(3S,5aR,9bS)-3,3a,4,5,5a,9b-hexahydro-3,5a,9-trimethylnaphto [1,2-b] furan-2,8-dione]

373. 255. Sārmu metālu pentacianonitrozilferāti (2-)

Alkali pentacyanonitrosylferrate (2-)

374. 297. Selēnsun tā savienojumi, izņemot selēna disulfīdu, ievērojot šo noteikumu 3.pielikumā minētos nosacījumus

Selenium and its compounds with the exception of selenium disulphide under the conditions set out under reference No 49 in Annex III, Part 1 of directive 76/768/EEC

375. 21. Simpatikomimētiskie amīni, kas iedarbojas uz centrālo nervu sistēmu

Sympathicomimetic amines acting on the central nervous system: any substance contained in the first list of medicaments which are subject to medical prescription and are referred to in resolution AP (69) 2 of the Council of Europe

376. 110. Sintētiskie kurarizanti Synthetic curarizants

377. 299. Sparteīns un tā sāļi Sparteine and its salts

378. 4. Spironolaktons Spironolactone

379. 305. Strihnīnkoku sugas un togalēniskie preparāti

Strychnos species and their galenical preparations

380. 304. Strihnīns un tā sāļi Strychnine and its salts

381. 302. Strofantīni, toaglukoni un attiecīgie atvasinājumi

Strophantines, their aglucones and their respective derivatives


No.Number in the

Annex to Directive

Name of ingredient


382. 303. Strofantu sugas un togalēniskie preparāti

Strophantus species and their galenical preparations

383. 402. Stroncija laktāts Strontium lactate

384. 403. Stroncija nitrāts Strontium nitrate

385. 404. Stroncija polikarboksilāts Strontium polycarboxylate

386. 150. Sukcīnnitrils Succinonitrile

387. 155. Sulfīnpirazons Sulfinpyrazone

388. 307. Sulfonamīdi (sulfanilamīds un tā atvasinājumi, kas iegūti, aizstājot vienu vai vairākus amino grupu ūdeņražu atomus) un to sāļi

Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts

389. 308. Sultiāms Sultiame

390. 289. Svins un tā savienojumi, izņemot svina acetātu, kura lietošana ir atļauta saskaņā ar šo noteikumu 3.pielikumu

Lead and its compounds, with the exception of that mentioned in Annex III, No 55 of directive 76/768/EEC under the conditions stated

391. 332. Šenokaulona sēklas un galēniskie preparāti

Schoenocaulon officinale Lind. (seeds and galenical preparations)

392. 416. Šūnas, audi vai citi cilvēka izcelsmes produkti

Cells, tissues or products of human origin

393. 280. Talidomīds un tā sāļi Thalidomide and its salts

394. 317. Tallijsun tā savienojumi Thallium and its compounds

395. 237. Tefazolīns un tā sāļi Tefazoline and its salts

396. 312. Telūrs un tā savienojumi Tellurium and its compounds

397. 139. Tetrabenazīnsun tā sāļi Tetrabenazine and its salts

398. 350. Tetrabromosalicilanilīdi Tetrabromosalicylanilides

399. 276. Tetraetilpirofosfāts; TEPP (ISO) Tetraethyl pyrophosphate; TEPP (ISO)

400. 394. Tetrahidrozolīns un tā sāļi Tetrahydrozoline and its salts

401. 367. 2,3,7,8-tetrahlordibenzo-p-dioksīns 2,3,7,8,-Tetrachlorodibenzo-p-dioxin

402. 314. Tetrahloretilēns Tetrachloroethylene

403. 315. Tetrahlorogleklis Carbon tetrachloride

404. 348. Tetrahlorsalicilanilīdi Tetrachlorosalicylanilides

405. 63. Tetrakaīnsun tā sāļi Tetracaine and its salts

406. 61. Tetrilamonija bromīds Tetrylammonium bromide

407. 318. Tevētijasglikozīdu ekstrakts Thevetia neriifolia Juss., glycoside extract

408. 233. Tiamazols Thiamazole

409. 310. Tiotepa Thiotepa


No.Number in the

Annex to Directive

Name of ingredient


410. 321. Tiourīnviela un tāsatvasinājumi, izņemot tos, kas minēti šo noteikumu 3.pielikumā

Thiourea and its derivatives, with the exception of the one listed in Annex III, Part 1 of directive 76/768/EEC

411. 9. Tiropropīnskābe un tās sāļi Thyropropic acid and its salts

412. 392. Tirotricīns Thyrothricine

413. 354. Tiurāma disulfīdi Thiuram disulphides

414. 353. Tiurāma monosulfīdi Thiuram monosulphides

415. 177. Tolboksāns Tolboxane

416. 65. Tolbutamīds Tolbutamide

417. 32. Toluidīni, toizomēri,sāļi un tā halogēnus un sēru saturošie atvasinājumi

Toluidines, their isomers, salts and halogenated and sulphonated derivatives

418. 324. Tranilcipromīnsun tā sāļi Tranylcypromine and its salts

419. 328. Tretamīns Tretamine

420. 375. Tretinoīns (retīnskābe un tās sāļi) Tretinoin (retinoic acid and its salts)

421. 275. Triamterēns un tā sāļi Triamterene and its salts

422. 326. 2,2,2-tribrometanols (tribrometilspirts) 2,2,2-Tribromoethanol (tribromoethyl alcohol)

423. 373. 3,4’,5-tribromsalicilanilīds 3,4’,5-Tribromosalicylanilide

424. 188. Trifluperidols Trifluperidol

425. 77. 2,2,2-trihloretān-1,1-diols 2,2,2-Trichloroethane-1,1-diol

426. 10. Trihloretiķskābe Trichloroacetic acid

427. 370. N-(trihlormetiltio)-4-cikloheksēn-1,2-dikarboksimīds (kaptāns)

N-(trichloromethylthio)-4-cyclohexene-1,2-dicarboximide (captan)

428. 327. Trihlormetīns un tā sāļi Trichlormethine and its salts

429. 325. Trihlornitrometāns (hlorpikrīns) Trichloronitromethane (chloropicrine)

430. 51. 2,2,6-trimetil-4-piperidil-benzoāts(benzamīns) un tā sāļi

2,2,6-Trimethyl-4-piperidyl benzoate (benzamine) and its salts

431. 449. 3,6,10-trimetil-3,5,9-undekatrien-2-ons, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

3,6,10-Trimethyl-3,5,9-undecatrien-2-one (CAS No 1117-41-5), when used as a fragrance ingredient

432. 222. 3,4,5-trimetoksifenetilamīns un tā sāļi 3,4,5-Trimethoxyphenethylamine and its salts

433. 92. Triparanols Triparanol

434. 347. Tripelēnamīns Tripelennamine

435. 277. Tritolilfosfāts Tritolyl phosphate

436. 27. Tuamīnheptāns,tā izomēri un sāļi Tuaminoheptane, its isomers and salts

437. 330. Urginejauntāsgalēniskie preparāti Urginea scilla Stern. and its galenical preparations


No.Number in the

Annex to Directive

Name of ingredient


438. 218. Uzpūstā lobēlijauntāsgalēniskie preparāti

Lobelia inflata L. and its galenical preparations

439. 323. Vakcīnas, toksīni vai serumi, kas minēti 1975.gada 20.maija Padomes Direktīvas 75/319/EEK pielikumā

Vaccines, toxins or serums listed in the Annex to the second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ No L 147, 9.6.1975, p.13)

440. 184. Valnoktamīds Valnoctamide

441. 203. Varfarīnsun tā sāļi Warfarin and its salts

442. 333. Veratru (čemeriņu) sugas un to preparātiVeratrum spp. and their preparations

443. 331. Veratrīns, tāsāļi un galēniskie preparāti Veratrine, its salts and galenical preparations

444. 37. Vielasar androgēnu iedarbību Substances with androgenic effect

445. 334. Vinilhlorīda monomērs Vinyl chloride monomer

446. 436. Vīģes koka lapu absolūts, ja to lieto kā smaržas sastāvdaļu (smaržvielu)

Fig leaf absolute (Ficus carica) (CAS No 68916-52-9), when used as a fragrance ingredient

447. 296. Zelta sāļi Gold salts

448. 11. Zilās kurpītes lapas, saknes un galēniskie preparāti

Aconitum napellus L. leaves, roots and galenical preparations

449. 24. Zoksazolamīni Zoxazolamine




20 April 2004

Ingredients the Use of which is Restricted in Cosmetic Products

I. Ingredients the Use of which is Permitted in the Referred to Fields in Observance of the Specified Concentration

Restrictions on use

No.

p.k.Name of ingredient field of application

Maximum permissible concentration in finished

cosmetic products

other restrictions and requirements

conditions of use and warnings which must be specified on the

labelling

in Latvian in English

1 2 3 4 5 6 7

1. Alumīnija cirkonija hlorīda hidroksīda kompleksie savienojumi AlxZr(OH)yClz

un alumīnija cirkonija hlorīda hidroksīda glicīna kompleksie savienojumi

Aluminium zirconium chloride hydroxide complexes AlxZr(OH)yClz and the aluminium zirconium chloride hydroxide glycine complexes

Antiperspirants 20% (calculated as anhydrous aluminium zirconium chloride hydroxide);

5.4% (calculated as zirconium)

The ratio of the number of aluminium atoms to the number of zirconium atoms must be in the range between two and 10.

The ratio of the sum of aluminium and zirconium atoms to the number of chlorine atoms must be in the range between 0.9 and 2.1.

Prohibited in aerosols

Do not apply to irritated or damaged skin


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

2. Alumīnija fluorīds Aluminium fluoride Products for oral cavity hygiene

0.15% (calculated as fluorine. If used with other fluorine components permitted in this Annex, the total fluorine content shall not exceed 0.15%)

Contains aluminium fluoride

3. Alvas fluorīds Stannous fluoride Products for oral cavity hygiene


Contains stannous fluoride

4. Amilkanēļaldehīds Amyl cinnamal

(CAS No 122-40-7)

The list of ingredients must specify the presence of a substance if the concentration of the substance exceeds:

1) 0.001 % in cosmetic products which are not rinsed off after use;

2) 0.01 % in cosmetic products which must be rinsed off after use


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

5. Amilkanēļspirts Amylcinnamyl alcohol

(CAS No 101-85-9)



2) 0.01 % in cosmetic products which must be rinsed off after use;

6. Amonija fluorīds Ammonium fluoride Products for oral cavity hygiene


Contains ammonium fluoride

7. Amonija fluorsilikāts Ammonium fluorosilicate Products for oral cavity hygiene


Contains ammonium fluorosilicate

8. Amonija joni Ammonia 6 % (calculated as ammonia) Contains ammonia (If its content exceeds 2%)


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

9. Amonija monofluorfosfāts Ammonium monofluorophosphate

Products for oral cavity hygiene


Contains ammonia monofluoro-phosphate

10. Anīsspirts Anisyl alcohol

(CAS No 105-13-5)



2) 0.01 % in cosmetic products which must be rinsed off after use.

11. Benzalkonija hlorīds, bromīds un saharināts

Benzalkonium chloride, bromide and saccharinate

1) hair and scalp care products which must be rinsed out after use

1) 3% (calculated as benzalkonium chloride);

Concentration of benzalkonium chloride, bromide and saccharinate (with alkyl groups that contain 14 or fewer carbon atoms) in finished products shall not exceed 0.1% (calculated as benzalkonium chloride)

1) Prevent contact with the eyes


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

2) other products 2) 0.1% (calculated as benzalkonium chloride)

2) Prevent contact with the eyes

12. Benzilbenzoāts Benzyl benzoate

(CAS No 120-51-4)


1) 0.001% in cosmetic products which are not rinsed off after use;


13. Benzilcinamāts Benzyl cinnamate

(CAS No 103-41-3)





Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

14. Benzilsalicilāts Benzyl salicylate

(CAS No 118-58-1)




15. Benzilspirts Benzyl alcohol

(CAS No 100-51-6)

Solvents, perfume and aromatic compositions





Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

16. Benzoilperoksīds Benzoyl peroxide Artificial fingernail systems 0.7% (after mixing) For professional use only. For professional use only.

Prevent contact with the skin.

Read package leaflet carefully before use

17. Borskābe, borāti un tetraborāti

Boric acid, borates and tetraborates

1) talc; 1) 5 % (calculated as boric acid)

1) Prohibited for use in products intended for children under three years of age.

Prohibited for use on irritated or peeling skin if the content of soluble borates exceeds 1.5% (calculated as boric acid);

1) Do not use on children under three years of age.

Do not use on irritated or peeling skin

2) general hygiene products 2) 0.1 % (calculated as boric acid)

2) Prohibited for use on children under three years of age

2) do not swallow.

Prohibited for use on children under three years of age.

3) other products, except bath and shower preparations, as well as hairdressing products

3) 3 % (calculated as boric acid)

3) prohibited for use in products intended for children under three years of age. Prohibited for use on irritated or peeling skin if the content of soluble borates exceeds 1.5% (calculated as boric acid);

3) Prohibited for use on children under three years of age.

Do not use on irritated or peeling skin


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

18. 2-(4-terc-butilbenzil) propionaldehīds

2-(4-tert-Butylbenzyl) propionaldehyde

(CAS No 80-54-6)


1) 0.001 % in cosmetic products which are not rinsed after use;


19. Cinka 4-hidroksibenzola sulfonāts

Zinc 4-hydroxybenzene sulphonate

Deodorants, anti-perspirants, astringent lotions

6% (calculated from anhydrous substance)

Prevent contact with the eyes

20. Citrāls Citral

(CAS No 5392-40-5)





Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

21. Citronelols Citronellol

(CAS No 106-22-9)




22. Diaminofenoli(1) Diaminophenols Oxidising hair dyes 10% (calculated as free base)

a) for professional use a) For professional use only. Contains diaminophenols. May produce an allergic reaction. Use appropriate gloves

b) for general use May produce an allergic reaction. Contains diaminophenols. Do not use for dyeing eyelashes or eyebrows.

23. 2.4-diamino-pirimidīn-3-oksīds

2.4-Diamino-pyrimidine-3-oxide (CAS No 74638-76-9)

Hair care products 1.5 %


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

24. Dichloromethane Dichloromethane 35% (when mixed with 1.1.1-trichloroethane, total concentration must not exceed 35%)

0,2 % (maximum impurity content)

25. Dihlorofēns Dichlorophen 0.5 % Contains dichlorophen

26. Etidronskābe un tās sāļi (1-hidroksi-etilidēndifosfonskābe un tās sāļi)

Etidronic acid and its salts (1-hydroxyethylidene-di-phosphonic acid and its salts)

1) hair care products; 1) 1.5 % (calculated as etidronic acid);

2) soaps 2) 0.2% (calculated as etidronic acid);

27. Eigenols Eugenol

(CAS No 97-53-0)





Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

28. Farnezols Farnesol

(CAS No 4602-84-0)




29. m- un p-fenilēndiamīni, to slāpekļa aizvietotie atvasinājumi un to sāļi;

o-fenilēndiamīnu slāpekļa aizvietotie atvasinājumi (4) , izņemot tos atvasinājumus, kas iekļauti citur šajā pielikumā

m- and p-Pheny-lenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-phenylene-diamines, with the exception of those derivatives listed elsewhere in this Annex

Oxidising hair dyes 6 % (calculated as free base)

a) for professional use a) For professional use only. Contains phenylenediamines. May produce an allergic reaction. Use appropriate gloves

b) for general use b) may produce an allergic reaction. Contains phenylenediamines. Do not use for dyeing eyelashes or eyebrows.


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

30. 1-fenoksipropān-2-ols 1-Phenoxy-propan-2-ol Products to be rinsed out after use.

Use in products for oral cavity hygiene prohibited

2 % If used as a preservative – in conformity with Annex 5 of these Regulations

31. Fenols un tā sārmu metālu sāļi

Phenol and its alkali salts Soaps and shampoos 1% (calculated as phenol) Contains phenol

32. Formaldehyde Formaldehyde Nail hardeners 5% (calculated as formaldehyde)

Protect cuticles with grease or oil.

Contains formaldehyde. (If its concentration exceeds 0.05 %)

33. Geraniols Geraniol

(CAS No 106-24-1)





Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

34. Heksadecilamonija fluorīds Hexadecyl ammonium fluoride Products for oral cavity hygiene


Contains hexadecilammonium fluoride

35. 3-(N-heksadecil-N-2-hidroksietilamonija) propilbis (2-hidroksietil) amonija difluorīds

3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride



Contains 3-(N-Hexadecyl-N-2-hydroxy-ethylammonio) propylbis (2-hydroxyethyl) ammonium dihydrofluoride

36. Heksilkanēļaldehīds Hexyl cinnam-aldehyde

(CAS No 101-86-0)





Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

37. Hidrohinona metilēteris Hydroquinone methylether Artificial fingernail systems 0.02 % (pēc sajaukšanas lietošanai)

For professional use only. For professional use only.


Read package leaflet carefully before use

38. Hidrohinons (2) Hydroquinone 1) Oxidising hair dyes 1) 0.3 %

a) for professional use 1) a) For professional use only.

Contains hydroquinone.

If the product comes into contact with the eyes, rinse them immediately.

b) for general use 1) b) Do not use for dyeing eyelashes or eyebrows.

If the product comes into contact with the eyes, rinse them immediately

Satur hidrohinonu.

2) in artificial fingernail systems

2) 0.02 % (after mixing for use)For professional use only. 2) For professional use only.


Read instructions for use carefully before using


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

39. Hidroksicitronelaldehīds Hydroxy-citronellal

(CAS No 107-75-5)




40. 1.3-Bis (hidroksimetil) imidazolidin-2-tions

1.3-Bis (hydroxymethyl) imidazolidine-2-thione

1) hair care products; 1) up to 2% 1) prohibited in aerosols; Contains 1.3-Bis(hydroxymethyl) imidazolidine -2-thione

2) nail care products 2) up to 2% 2) in finished products pH shall not exceed 4


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

41. Hidroksimetilpentil-cikloheksēnkarboks-aldehīds

Hydroxy-methylpentyl-cyclohexenecarboxalde-hyde

(CAS No 31906-04-4)




42. Hinīns un tā sāļi Quinine and its salts 1) shampoos 1) 0.5 % (calculated as quinine base)

2) hair lotions 2) 0.2% (calculated as quinine base)

43. Hinolīn-8-ols un bis (8-hidroksihinolīna) sulfāts

Quinolin-8-ol and bis (8-hydroxy-quinolium) sulphate

1) Hydrogen peroxide stabiliser in hair care products that must be rinsed out after use.

0.3 % (calculated as the base)

Hydrogen peroxide stabiliser in hair care products that need not be rinsed out after use

0.03 % (calculated as the base)


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

44. Izoeigenols Isoeugenol

(CAS No 97-54-1)




45. Kalcija fluorīds Calcium fluoride Products for oral cavity hygiene


Contains calcium fluoride

46. Kalcija hidroksīds Calcium hydroxide 1) hair straighteners containing two components: calcium hydroxide and guanidine salt;

1) 7 % as calcium dihydroxide mass

1) contains alkali.

Prevent contact with the eyes.

Keep away from children.

Can cause blindness.

2) pH regulator in depilatories

2) pH may not exceed pH 12.7 2) contains alkali. Keep away from children. Prevent contact with the eyes


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

3) other applications (for example, pH regulator, processing aid)

3) pH may not exceed pH 11

47. Kalcija monofluorfosfāts Calcium monofluoro-phosphateProducts for oral cavity hygiene


Contains calcium monofluoro-phosphate

48. Kanēļaldehīds Cinnamal

(CAS No 104-55-2)





Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

49. Kanēļspirts Cinnamyl alcohol

(CAS No 104-54-1)




50. Kālija fluorīds Potassium fluoride Products for oral cavity hygiene


Contains potassium fluoride

51. Kālija fluorsilikāts Potassium fluorosilicate Products for oral cavity hygiene


Contains potassium fluorosilicate


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

52. Kālija monofluorfosfāts Potassium monofluorophosphate



Contains potassium monofluor-phosphate

53. Kālija vai nātrija hidroksīds Potassium or sodium hydroxide 1) nail care products (nail cuticle solvents);

1) 5 % (3) 1) contains alkali. Prevent contact with the eyes. Can cause blindness. Keep away from children

2) hair straighteners:

a) for professional use a) 4.5 % (3) a) For professional use only. Prevent contact with the eyes. Can cause blindness.

b) for general use b) 2% (3) b) Contains alkali.

Prevent contact with the eyes. Can cause blindness. Keep away from children

3) pH regulator – in depilatories

3) up to pH 12.7 3) Keep away from children. Prevent contact with the eyes

4) pH regulator – in other preparations

4) up to pH 11


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

54. Kumarīns Coumarin

(CAS No 91-64-5)




55. Ķērpja Evernia furfuracea Mann. ekstrakts

Treemoss extract

(CAS No 90028-67-4)





Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

56. Kērpja Evernia prunastri (L.) Ach. ekstrakts

Oak moss extract

(CAS No 90028-68-5)




57. d-limonēns d-Limonene

(CAS No 5989-27-5)





Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

58. Linalols Linalool

(CAS No 78-70-6)




59. Litija hidroksīds Lithium hydroxide 1) hair straighteners:

a) for professional use a) 4.5 % (3) a) For professional use only.



b) for general use b) 2% (3) b) Contains alkali.





Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

2) pH regulator – in depilatories

2) pH may not exceed pH 12.7 2) Contains alkali.



3) pH regulator – in other preparations intended to be rinsed off

3) pH may not exceed pH 11

60. Magnija fluorīds Magnesium fluoride Teeth hygiene products 0.15% (calculated as fluorine. If used with other fluorine components permitted in this Annex, the total fluorine content shall not exceed 0.15%)

Contains magnesium fluoride

61. Magnija fluorsilikāts Magnesium fluorosilicate Products for oral cavity hygiene


Contains magnesium fluorosilicate

62. Metilfenilēndiamīni, to Methylphenylenediamines, Oxidising hair dyes: 10% (calculated as free base)


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

slāpekļa aizvietotie atvasinājumi un to sāļi(1), izņemot šo noteikumu 2.pielikumā minēto 4-metil-m-fenilēndiamīnu un tā sāļus

their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II

a) for professional use a) For professional use only.

Contains phenylenediamines. May produce an allergic reaction.

Use appropriate gloves.

b) for general use b) May produce an allergic reaction.

Contains phenylenediamines. Do not use for dyeing eyelashes or eyebrows.

63. Metilheptīnkarbonāts Methyl heptin carbonate

(CAS No 111-12-6)




64. 6-metilkumarīns 6-methylcoumarin (CAS No 92-48-8)


0.003 %


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

65. Metilspirts Methanol Denaturant of ethyl alcohol and isopropyl alcohol

5% (calculated from the content of ethyl alcohol and isopropyl alcohol)

66. 3-metil-4-(2.6.6-tri-metil-2-cikloheksēn-1-il)-3-butēn-2-ons

3-Methyl-4-(2.6.6-tri-methyl-2-cyclohexen-1-yl)-3-buten-2-one

(CAS No 127-51-5)





Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

67. Monoalkilamīni, monoalkanolamīni un to sāļi

Monoalkylamines, monoalkanolamines and their salts

Maximum content of secondary amines: 0.5 %

Do not use with nitrosating systems.

Minimum degree of purity: 99 %.

Maximum content of secondary amines: 0.5% (applies to raw materials).

Maximum content of nitrosamines: 50 µg/kg.

Keep in a package free of nitrites

68. 1-naftols un tā sāļi 1-Naphthol (CAS No 90-15-3) and its salts

Oxidising hair dyes 2.0 % Together with hydrogen peroxide the maximum concentration for use shall be 1.0 %

May produce an allergic reaction.

69. Nātrija fluorīds Sodium fluoride Products for oral cavity hygiene


Contains sodium fluoride


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

70. Nātrija fluorsilikāts Sodium fluorosilicate Products for oral cavity hygiene


Contains sodium fluorosilicate

71. Nātrija monofluorfosfāts Sodium monofluoro-phosphate Products for oral cavity hygiene


Contains sodium monofluoro-phosphate

72. Nātrija nitrīts Sodium nitrite (CAS No 7632-00-0)

Rust inhibitor 0,2 % Do not use with secondary and/or tertiary amines or other substances that constitute nitrosamines

73. Nātrija tozilhloramīds Tosylchloramide sodium 0,2 %

74. Nikometanola hidrofluorīds Nicomethanol hydrofluoride Products for oral cavity hygiene


Contains nicomethanol hydrofluoride

75. Nitromethane Nitromethane Rust inhibitor 0.3 %


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

76. Oktadecenilamonija fluorīds

Octadecenyl-ammonium fluoride



Contains octadecenyl-ammonium fluoride

77. Poliakrilamīdi Polyacrylamides 1) body-care products which are not washed off

1) maximum content of acrylamide residues 0.1 mg/kg

2) other cosmetic products 2) maximum content of acrylamide residues 0.5 mg/kg

78. Rezorcīns (2) Resorcinol (CAS No 108-46-3) 1) oxidising hair dyes 1) 5 %;

a) for professional use a) For professional use only. Contains resorcinol.


b) for general use b) Contains resorcinol. Rinse hair well after application. Do not use for dyeing eyebrows or eyelashes.



Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

2) hair lotions and shampoos 2) 0.5 % 2) Contains resorcinol

79. Chlorates of alkali metals Chlorates of alkali metals 1) toothpastes; 1) 5 %

2) other products 2) 3 %

80. Sulphides of alkali metals Alkali sulphides Depilatories 2 % (calculated as sulphur); pH up to 12.7

Keep away from children. Prevent contact with the eyes

81. Alkaline earth sulphides Alkaline earth sulphides Depilatories 6% (calculated as sulphur); pH up to 12.7

Keep away from children. Prevent contact with the eyes

82. Selenium disulphide Selenium disulphide Anti-dandruff shampoos 1 % Contains selenium disulphide Prevent contact with the eyes or damaged skin

83. Skābeņskābe, tās esteri un bāziskie sāļi

Oxalic acid, its esters and alkaline salts

Hair care products 5 % For professional use only.

84. Stroncija acetāta hemihidrāts

Strontium acetate hemihydrate Toothpastes 3.5% (calculated as strontium. When mixed with other strontium products, the total strontium content shall not exceed 3.5%)

Contains strontium acetate.

Not recommended for frequent use on children

85. Stroncija hidroksīds Strontium hydroxide pH regulator in depilatories 3.5% (calculated as strontium);

maximum pH 12.7




Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

86. Stroncija hlorīda heksahidrāts

Strontium chloride hexahydrate 1) toothpastes; 1) 3.5 % (calculated as strontium. When mixed with other strontium compounds, the total strontium content shall not exceed 3.5%)

Contains strontium chloride. Not recommended for frequent use on children

2) shampoos and facial skin care products

2) 2.1% (calculated as strontium). When mixed with other strontium compounds, the total strontium content shall not exceed 2.1 %)

87. Stroncija peroksīds Strontium peroxide Hair care products intended for professional use that must be rinsed out after use

4.5% (calculated as strontium for use in the finished product)

All products shall conform to the requirements for release of hydrogen peroxide

Prevent contact with the eyes. If the product comes into contact with the eyes, rinse them immediately. For professional use only. Use appropriate gloves

88. Silver nitrate Silver nitrate Only in products for dyeing eyebrows and eyelashes

4 % Contains silver nitrate.

If the product comes into contact with the eyes, rinse them immediately


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

89. Svina acetāts Lead acetate Only in hair dyeing products 0.6% (calculated as lead) Keep away from children. Prevent contact with the eyes. Wash hands after use. Contains lead acetate. Do not use for dyeing eyebrows, eyelashes or moustaches. Stop use if irritation occurs

90. Talks: magnija silikāta hidrāts

Talc: Hydrated magnesium silicate

1) powdered products for children under three years of age;

1) Keep away from the nose and mouth of a child

2) other products

91. Taukskābju dialkilamīdi un dialkanolamīdi

Fatty acid dialkylamides and dialkanolamides

Maximum content of secondary amines: 0.5 %

Do not use with nitrosating systems.



Keep in packaging free of nitrites.

92. Tetraborāti Tetraborates 2) bath and shower products; 1) 18 % (calculated as boric acid)

1) prohibited for use on children under three years of age

1) Prohibited for use on children under three years of age


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

2) hairdressing products; 2) 8% (calculated as boric acid) 2) Rinse thoroughly

93. Tioglikolskābe un tās sāļi Thioglycollic acid and its salts 1) hairdressing or hair straightening products:

In the conditions of use the following shall be indicated in the official language:

1), 2), 3) “Nepieļaut nokļūšanu acīs .

Ja nokļūst acīs, tās nekavējoties skalot ar lielu daudzumu ūdens un meklēt medicīnisku palīdzību”. [Prevent contacts with the eyes. In case of contact with eyes, rinse immediately with a large quantity of water and seek medical advice

1), 3) “Lietot atbilstošus cimdus.” [Use suitable gloves.]

1) Contains thioglycollate.

Observe instructions.

Keep away from children

For professional use only.

a) for professional use 11 % pH 7–9.5;

b) vispārējai lietošanai 8 %; pH 7–9.5;

2) depilatories; 5 %; pH 7–12.7; 2), 3) Contains thioglycollate.


Keep away from children3) other hair care products which must be rinsed out after use

2 %; pH 7–9.5.

(content in percentage calculated as thioglycollic acid for use in the finished product)

94. Tioglikolskābes esteri Thioglycollic acid esters Hairdressing products or hair-straightening products:

In the conditions of use the following shall be indicated in the official language:

“Saskaroties ar ādu var izraisīt a) for professional use 11 % in the finished product

pH 6-9.5a) For professional use only.


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

paaugstinātu jūtīgumu.

Nepieļaut nokļūšanu acīs.

Ja nokļūst acīs, tās nekavējoties skalot ar lielu daudzumu ūdens un meklēt medicīnisku palīdzību [May cause sensitation by skin contact. Prevent contacts with eyes. In case of contact with eyes, rinse immediately with a large quantity of water and seek medical advice

Use suitable gloves.]

b) for general use 8 % in the finished product pH 6-9.5

(Content in percentage referred to above has been calculated as thioglycollic acid for use in the final product)

b) Contains thiodiglycol.


Keep away from children


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

95. Trialkilamīni, trialkanolamīni un to sāļi

Trialkylamines, trialkanolamines and their salts

1) products not intended to be rinsed;

1) 2.5 % 1), 2) Do not use with nitrosating systems.

Minimum degree of purity: 99 %.



Keep in packaging free of nitrites

2) other products

96. N,N’,N’-tris (poli-oksietilēn)-N-heksadecilpropilēn-diamīndihidrofluorīds

N,N’,N’-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride



Contains NN'N'-Tris (polyoxyethylene)-N-hexadecyl propylene diamine dihydrofluoride

97. Ūdenī šķīstošie cinka sāļi, izņemot cinka 4-hidroksibenzol-sulfonātu un cinka piritionu

Water-soluble zinc salts with the exception of zinc 4-hydroxybenzenesulphonate and zinc pyrithione

1% (calculated as zinc)


Restrictions on use

No.



cosmetic products



labelling


1 2 3 4 5 6 7

98. Ūdeņraža peroksīds un citi savienojumi vai maisījumi, kas izdala ūdeņraža peroksīdu, ieskaitot karbamīda peroksīdu un cinka peroksīdu

Hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide

1) hair care products; 1) 12% presence or release of hydrogen peroxide (40 volumes)

1) Use suitable gloves

1), 2), 3) Contains hydrogen peroxide.

Prevent contact with the eyes. If the product comes into contact with the eyes, rinse them immediately

2) skin care products 2) 4% presence or release of hydrogen peroxide

3) nail hardeners; 3) 2% presence or release of hydrogen peroxide

4) products for oral cavity hygiene

4) 0.1% presence or release of hydrogen peroxide

Notes.(1) Ingredients may be used separately or in combination so that the sum of the ratios – amount of ingredients (in mass percentage) in a cosmetic product in relation to the maximum concentration thereof does not exceed 1.(2) Ingredients may be used separately or in a combination so that the sum of the ratios – amount of ingredients (in mass percentage) in a cosmetic product in relation to the maximum concentration thereof does not exceed 2.(3) Sodium, potassium or lithium hydroxide shall be calculated for ingredients in the weight of sodium hydroxide. When these ingredients are used in combination, the sum of such ingredients may not exceed the maximum permissible concentration specified in Column 5 of this Annex.(4) Ingredients may be used separately or in a combination so that the sum of the ratios – the amount of ingredients (in mass percentage) in a cosmetic product in relation to the maximum concentration thereof does not exceed 1.


II. Ingredients the Use of which is Permitted for a Limited Period of Time in the Referred to Field of application, in Observance of the Specified Concentration

Name of ingredient Restrictions on useConditions of use and warnings which must

be specified on the labelling

Use permitted untilNo.

p.k.in Latvian in English field of application

maximum permissible

concentration in finished cosmetic

products


1 2 3 4 5 6 7 8

1. 3-amino-2.4-dihlorfenols un tā sāļi

3-Amino-2.4-dichlorophenol (CAS No 61693-43-4) and its salts

Oxidising hair dyes 2 % Together with hydrogen peroxide the maximum concentration for use shall be 1%.


30.09.2004.

2. m-aminofenols un tā sāļi m-Aminophenol (CAS No 591-27-5) and its salts

Oxidising hair dyes 2 % Together with hydrogen peroxide the maximum concentration for use shall be 1 %.


30.09.2004.

3. o-aminofenols un tā sāļi o-Aminophenol (CAS No 95-55-6) and its salts

Oxidising hair dyes 2 % Together with hydrogen peroxide the maximum concentration for use shall be 1%.

30.09.2004.

4. 2-amino-4-hidroksietilaminoanizols un tā sāļi

2-Amino-4-hydroxyethylaminoanisole (CAS No 83763-47-7) and its salts

Oxidising hair dyes 3 % Together with hydrogen peroxide the maximum concentration for use shall be 1.5 %.

30.09.2004.






maximum permissible


products


1 2 3 4 5 6 7 8

5. 4-amino-2-hidroksitoluols un tā sāļi

4-Amino-2-hydroxytoluene (CAS No 2835-95-2) and its salts

Oxidising hair dyes 3 % Together with hydrogen peroxide the maximum concentration for use shall be 1.5 %.

30.09.2004.

6. 2-amino-6-hlor-4-nitrofenols un tā sāļi

2-Amino-6-chloro-4-nitrophenol (CAS No 6358-09-4) and its salts

1) oxidising hair dyes 1) 2 % Together with hydrogen peroxide the maximum concentration for use shall be 1 %

30.09.2004.

2) non-oxidising hair dyes

2) 2 %

7. 4-amino-m-krezols un tā sāļi 4-Amino-m-cresol (CAS No 2835-99-6) and its salts

Oxidising hair dyes 3 % Together with hydrogen peroxide the maximum concentration for use shall be 1.5 %

30.09.2004.

8. 6-amino-o-krezols un tā sāļi 6-Amino-o-cresol (CAS No 17672-22-9) and its salts


30.09.2004.






maximum permissible


products


1 2 3 4 5 6 7 8

9. 2-aminometil-p-aminofenols un tā sāļi

2-Aminomethyl-p-aminophenol (CAS No 79352-72-0) and its salts


30.09.2004.

10. 2-amino-3-nitrofenols un tā sāļi 2-Amino-3-nitrophenol (CAS No 603-85-0) and its salts

1) oxidising hair dyes 1) 3 % Together with hydrogen peroxide the maximum concentration for use shall be 1.5 %

b) may produce an allergic reaction.

30.09.2004.

2) oxidising hair dyes 2) 3 %

11. 4-amino-3-nitrofenols un tā sāļi 4-Amino-3-nitrophenol (CAS No 610-81-1) and its salts


1), 2) may produce an allergic reaction

30.09.2004.

2) oxidising hair dyes 2) 3 %

12. Bāziskais violetais 14 (CI 42510)

Basic Violet 14 (CAS No 632-99-5) (CI 42510) and its salts

1) oxidising hair dyes 1) 0.3 % Together with hydrogen peroxide the maximum concentration for use shall be 0.15 %

30.09.2004.


2) 0.3 %

13. Bāziskais zilais 7 Basic Blue 7 (CAS No 2390-60-5)Non-oxidising hair dyes0,2 % May produce an allergic reaction.

30.09.2004.






maximum permissible


products


1 2 3 4 5 6 7 8

14. Bāziskais zilais 26 un tā sāļi (CI 44045)

Basic Blue 26 (CAS No 2580-56-5) (CI 44045) and its salts


30.09.2004.

2) oxidising hair dyes 2) 0.5 %

15. 3.4-diaminobenzoskābe un tās sāļi

3.4-Diamino-benzoicacid (CAS No 619-05-6)

Oxidising hair dyes 2 % Together with hydrogen peroxide the maximum concentration for use shall be 1 %

30.09.2004.

16. 2.4-diaminofenoksi-etanols un tā sāļi

2.4-Diaminophenoxyethanol (CAS No 66422-95-5) and its salts


30.09.2004.

17. 1.3-bis-(2.4-diaminofenoksi)propāns un tā sāļi

1.3-Bis-(2.4-diaminophenoxy)-propane (CAS No 81892-72-0) and its salts



30.09.2004.






maximum permissible


products


1 2 3 4 5 6 7 8

18. 2.4-diamino-5-metilfenetols un tā sāļi

2.4-Diamino-5-methylphenetol (CAS No 113715-25-6) and its salts



30.09.2004.

9. 2.4-diamino-5-metilfenoksietanols un tā sāļi

2.4-Diamino-5-methylphenoxyethanol (CAS No 141614-05-3) and its salts



30.09.2004.

20. 2.6-dihidroksi-3.4-dimetilpiridīns un tā sāļi

2.6-Dihydroxy-3.4-dimethylpyridine (CAS No 84540-47-6) and its salts



30.09.2004.

21. 2.6-dimetoksi-3.5-piridīndiamīns un tā sāļi

2.6-Dimethoxy-3.5-pyridinediamine (CAS No 85679-78-3) and its salts



30.09.2004.

22. Dzeltenais Nr.6 un tā sāļi Yellow No 6 (CAS No 104333-00-8) and its salts

1) oxidising hair dyes 1) 2 % Together with hydrogen peroxide

30.09.2004.






maximum permissible


products


1 2 3 4 5 6 7 8

the maximum concentration for use shall be 1 %


2) 1 %

23. Fenilmetilpirazolons un tā sāļi Phenyl methyl pyrazolone (CAS No 89-25-8) and its salts


30.09.2004.

24. HC dzeltenais Nr.10 un tā sāļi HC Yellow No 10 (CAS No 109023-83-8) and its salts

Non-oxidising hair dyes0,2 % 30.09.2004.

25. HC dzeltenais Nr.12 un tā sāļi HC Yellow No 12 (CAS No 59320-13-7) and its salts


30.09.2004.


2) 0.5 %

6. HC oranžais Nr.2 un tā sāļi HC Orange No 2 (CAS No 85765-48-6) and its salts

Non-oxidising hair dyes1 % 30.09.2004.

27. HC sarkanais Nr.10 + HC sarkanais Nr.11 un to sāļi

HC Red No 10 + HC Red No 11 (CAS No 95576-89-9 + 95576-92-4) and its salts


30.09.2004.


2)1 %






maximum permissible


products


1 2 3 4 5 6 7 8

28. HC sarkanais Nr.13 un tā sāļi HC Red No 13 (CAS No 94158-13-1) and its salts


30.09.2004.


2) 2.5 %

29. HC violetais Nr.1 un tā sāļi HC Violet No 1 (CAS No 82576-75-8) and its salts


30.09.2004.


2) 0.5 %

30. HC violetais Nr.2 un tā sāļi HC Violet No 2 (CAS No 104226-19-9) and its salts


31. HC zilais Nr.2 un tā sāļi HC Blue No 2 (CAS No 33229-34-4) and its salts

Non-oxidising hair dyes2.8 % 30.09.2004.



30.09.2004.


2) 1 %






maximum permissible


products


1 2 3 4 5 6 7 8



30.09.2004.



1), 2) May produce an allergic reaction

30.09.2004.


2) 2 %




30.09.2004.


2) 1.5 %

36. Hidroksibenzomorfolīns un tā sāļi

Hydroxybenzomorpholine (CAS No 26021-57-8) and its salts



30.09.2004.






maximum permissible


products


1 2 3 4 5 6 7 8

37. Hidroksietilaminometil-p-aminofenols un tā sāļi

Hydroxyethylamino-methyl-p-aminophenol (CAS No 110952-46-0) and its salts


30.09.2004.

38. 2-hidroksietilamino-5-nitroanizols un tā sāļi

2-Hydroxy-ethylamino-5-nitro-anisole (CAS no 66095-81-6) and its salts


39. Hidroksietil-2.6-dinitro-p-anizidīns un tā sāļi

Hydroxyethyl-2.6-dinitro-p-anisidine (CAS No 122252-11-3) and its salts

Non-oxidising hair dyes3 % May produce an allergic reaction.

30.09.2004.

40. Hidroksietil-3.4-metilēndioksianilīns un tā sāļi

Hydroxyethyl-3.4-methylene-dioxyaniline (CAS No 81329-90-0) and its salts


30.09.2004.

41. Hidroksietil-2-nitro-p-toluidīns un tā sāļi

Hydroxyethyl-2-nitro-p-toluidine (CAS No 100418-33-5) and its salts



30.09.2004.


2) 1 %

42. 2-hidroksielilpikrīn-skābe un tās sāļi

2-Hydroxyethylpicramic acid (CAS No 99610-72-7) and its

1) oxidising hair dyes 1) 3 % Together with hydrogen peroxide


30.09.2004.






maximum permissible


products


1 2 3 4 5 6 7 8

salts the maximum concentration for use shall be 1.5 %


2) 2 %

43. 4-hidroksipropilamino-3-nitrofenols un tā sāļi

4-Hydroxypropylamino-3-nitrophenol (CAS No 92952-81-3) and its salts

1) oxidising hair dyes 1) 5,2 % Together with hydrogen peroxide the maximum concentration for use shall be 2.6 %

1), 2) may produce an allergic reaction

30.09.2004.


2) 2.6 %

44. Hidroksipropil bis (N-hidroksietil-p-fenilēndiamīns un tā sāļi

Hydroxypropyl bis (N-hydroxyethyl-p-phenylenediamine (CAS No 128729-30-6) and its salts



30.09.2004.

45. 2-hlor-6-etilamino-4-nitrofenols un tā sāļi

2-Chloro-6-ethylamino-4-nitrophenol (CAS No 131657-78-8) and its salts


30.09.2004.


2) 3 %

46. 2-hlor-5-nitro-N-hidroksietil-p- 2-Chloro-5-nitro-N-hydroxyethyl- 1) oxidising hair dyes 1) 2 % Together with 30.09.2004.






maximum permissible


products


1 2 3 4 5 6 7 8

fenilēndiamīns un tā sāļi p-phenylenediamine (CAS No 50610-28-1) and its salts

hydrogen peroxide the maximum concentration for use shall be 1 %


2) 1 %

47. p-metilaminofenols un tā sāļi p-Methylaminophenol (CAS No 150-75-4) and its salts



30.09.2004.

48. 3-metilamino-4-nitro-fenoksietanols un tā sāļi

3-Methylamino-4-nitro-phenoxyethanol (CAS No 59820-63-2) and its salts


49. 2-metil-5-hidroksietilaminofenols un tā sāļi

2-Methyl-5-hydroxyethylamino-phenol (CAS No 55302-96-0) and its salts



30.09.2004.

50. 2-metilrezorcīns un tā sāļi 2-Methylresorcinol (CAS No 608-25-3) and its salts


30.09.2004.

51. Muskusa ketons Musk ketone (CAS No 81-14-1) All cosmetic products, 1) in 1.4% perfumes 30.09.2004.






maximum permissible


products


1 2 3 4 5 6 7 8

except products for oral cavity hygiene

2) in 0.56% eau de toilette

3) 0.042% in other products

52. Muskusa ksilols Musk xylene (CAS No 81-15-2) All cosmetic products, except products for oral cavity hygiene

1) in 1% perfumes 30.09.2004.

2) in 0.4% eau de toilette

3) 0.03% in other products

53. 1.5-naftalīndiols un tā sāļi 1.5-Naphthalenediol (CAS No 83-56-7) and its salts


30.09.2004.




30.09.2004.






maximum permissible


products


1 2 3 4 5 6 7 8



30.09.2004.

56. 4-nitrofenil-aminoetilurīnviela un tās sāļi

4-Nitrophenyl aminoethylurea (CAS No 27080-42-8) and its salts


30.09.2004.


2) 0.5 %

57. 2-nitro-p-fenilēndiamīns un tā sāļi

2-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts


30.09.2004.


2) 0.3 %

58. 3-nitro-p-hidroksietilaminofenols un tā sāļi

3-Nitro-p-hydroxyethylamino-phenol (CAS No 65235-31-6) and its salts


30.09.2004.


2) 6 %

59. 6-nitro-2.5-piridīndiamīns un tā sāļi

6-Nitro-2.5-pyridinediamine (CAS No 69825-83-8) and its salts

Non-oxidising hair dyes3 % May produce an allergic reaction.

30.09.2004.






maximum permissible


products


1 2 3 4 5 6 7 8

60. Ponso SX (CI 14700) un tā sāļi Ponceau SX (CAS No 4548-53-2) (CI 14700) and its salts


61. Skābais melnais 52 un tā sāļi Acid Black 52 (CAS No 3618-58-4) and its salts


30.09.2004.

2. Skābais sarkanais 33 (CI 17200) un tā sāļi

Acid Red 33 (CAS No 3567-66-6) (CI 17200) and its salts





20 April 2004

Colouring Agents which are Permitted to be Included in the Composition of a Cosmetic Product (1), and Restrictions on the Use thereof

Field of application.

1. Utilisation of the colouring agents specified in Column 4 of the Table is permitted for all cosmetic products.

2. Utilisation of the colouring agents specified in Column 5 of the Table is permitted for all cosmetic products, except for those which are intended for use in the vicinity of the eyes, i.e., in eye make-up and eye make-up removers.

3. Utilisation of the colouring agents specified in Column 6 of this Table is permitted only for those cosmetic products, which may not come into contact with mucous membranes.

4. Utilisation of the colouring agents specified in Column 7 of this Table is permitted only for those cosmetic products, which are intended for only brief contact with the skin (for quick functional effect).

No.Dyes

International index (CI) or name of colouring agent

ColourRestrictions on use

field of application other restrictions and requirements (1)

1 2 3 4 5 6 7 8

1. 10006 Green X

2. 10020 Green X

3. 10316 (3) Yellow X

4. 11680 Yellow X

5. 11710 Yellow X

6. 11725 Orange X

7. 11920 Orange X

8. 12010 Red X

9. 12085 (3) Red X Maximum concentration in finished product 3%

10. 12120 Red X

11. 12150 Red X

12. 12370 Red X

13. 12420 Red X


No.Dyes




1 2 3 4 5 6 7 8

14. 12480 Brown X

15. 12490 Red X

16. 12700 Yellow X

17. 13015 Yellow X E 105

18. 14270 Orange X E 103

19. 14700 Red X

20. 14720 Red X E 122

21. 14815 Red X E 125

22. 15510 (3) Orange X

23. 15525 Red X

24. 15580 Red X

25. 15620 Red X

26. 15630 (3) Red X Maximum concentration in finished product 3%

27. 15800 Red X

28. 15850 (3) Red X

29. 15865 (3) Red X

30. 15880 Red X

31. 15980 Orange X E 111

32. 15985 (3) Yellow X E 110

33. 16035 Red X

34. 16185 Red X E 123

35. 16230 Orange X

36. 16255 (3) Red X E 124

37. 16290 Red X E 126

38. 17200 (3) Red X

39. 18050 Red X

40. 18130 Red X

41. 18690 Yellow X

42. 18736 Red X

43. 18820 Yellow X

44. 18965 Yellow X

45. 19140 (3) Yellow X E 102


No.Dyes




1 2 3 4 5 6 7 8

46. 20040 Yellow X Maximum concentration of 3.3'-dimethylbenzidine in the colouring agent 5 mg/kg (5 ppm)

47. 20170 Orange X

48. 20470 Black X



51. 21230 Yellow X

52. 24790 Red X

53. 26100 Red X Purity criteria: aniline

< 0,2 %;

2-naphthol < 0.2%;

4-aminoazobenzene

< 0.1 %;

1-(phenylazo) –2-naphthol

< 3 %;

1-[2-(phenylazo) phenylazo]-2-naphtalenol< 2 %

54. 27290(3) Red X E 152

55. 27755 Black X E 152

56. 28440 Black X E 151

57. 40215 Orange X

58. 40800 Orange X

59. 40820 Orange X E 160e

60. 40825 Orange X E 160f

61. 40850 Orange X E 161g

62. 42045 Blue X

63. 42051 (3) Blue X E 131

64. 42053 Green X

65. 42080 Blue X

66. 42090 Blue X

67. 42100 Green X


No.Dyes




1 2 3 4 5 6 7 8

68. 42170 Green X

69. 42510 Violet X

70. 42520 Violet X Maximum concentration in finished product 5 mg/kg (5 ppm)

71. 42735 Blue X

72. 44045 Blue X

73. 44090 Green X E 142

74. 45100 Red X

75. 45190 Violet X

76. 45220 Red X

77. 45350 Yellow X Maximum concentration in finished product 6%

78. 45370 (3) Orange X Not more than 1% 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid and 2% 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid*

79. 45380 (3) Red X Not more than 1% 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid and 2% 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid

80. 45396 Orange X Permitted only as free acid in lipsticks, at maximum concentration 1%

81. 45405 Red X Not more than 1% 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid and 2% 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid*

82. 45410 (3) Red X Not more than 1% 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid and 2% 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid*

83. 45425 Red X Not more than 1% 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid and 3% 2-(iodo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid


No.Dyes




1 2 3 4 5 6 7 8

84. 45430 (3) Red X E 127

Not more than 1% 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid and 3% 2-(iodo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid

85. 47000 Yellow X

86. 47005 Yellow X E 104

87. 50325 Violet X

88. 50420 Black X

89. 51319 Violet X

90. 58000 Red X

91. 59040 Green X

92. 60724 Violet X

93. 60725 Violet X

94. 60730 Violet X

95. 61565 Green X

96. 61570 Green X

97. 61585 Blue X

98. 62045 Blue X

99. 69800 Blue X E 130

100. 69825 Blue X

101. 71105 Orange X

102. 73000 Blue X

103. 73015 Blue X E 132

104. 73360 Red X

105. 73385 Violet X

106. 73900 Violet X

107. 73915 Red X

108. 74100 Blue X

109. 74160 Blue X

110. 74180 Blue X

111. 74260 Green X

112. 75100 Yellow X


No.Dyes




1 2 3 4 5 6 7 8

113. 75120 Orange X E 160b

114. 75125 Yellow X E 160d

115. 75130 Orange X E 160a

116. 75135 Yellow X E 161d

117. 75170 White X

118. 75300 Yellow X E 100

119. 75470 Red X E 120

120. 75810 Green X E 140 and E 141

121. 77000 White X E 173

122. 77002 White X

123. 77004 White X

124. 77007 Blue X

125. 77015 Red X

126. 77120 White X

127. 77163 White X

128. 77220 White X E 170

129. 77231 White X

130. 77266 Black X

131. 77267 Black X

132. 77268:1 Black X E 153

133. 77288 Green X Free from chromate ions

134. 77289 Green X Free from chromate ions

135. 77346 Green X

136. 77400 Brown X

137. 77480 Brown X E 175

138. 77489 Orange X E 172

139. 77491 Red X E 172

140. 77492 Yellow X E 172

141. 77499 Black X E 172

142. 77510 Blue X Free from cyanide ions

143. 77713 White X

144. 77742 Violet X

145. 77745 Red X


No.Dyes




1 2 3 4 5 6 7 8

146. 77820 White X E 174

147. 77891 White X E 171

148. 77947 White X

149. Lactoflavine Yellow X E 101

150. Carmel Brown X E 150

151. Kapsantīns, kapsorubīns Orange X E 160c

152. Biešu sarkanais Red X E 162

153. Antocianīni Red X E 163

154. Alumīnija, cinka, magnija un kalcija stearāti

White X

155. Bromtimolzilais Blue X

156. Bromkrezolzaļais Green X

157. Skābju sarkanais 195 Red X

Notes.(1) Use of the lacquers and salts of these colouring agents in the composition of a cosmetic product is permitted, if such do not contain the substances which are included in Annex 2 of these Regulations or excluded from the scope of these Regulations in accordance with Paragraph 3 of these Regulations.(2) The colouring agent marked with the letter “E” and with the relevant number (international food additive number) must conform with the identity and purity criteria of food additives which are indicated in regulatory enactments specifying the mandatory harmlessness requirements for food in which food additives are utilised.(3) Use of insoluble barium, strontium and zirconium lacquers, salts and pigments of these colouring agents is permitted, if such conform with the criteria specified in the standards referred to in Annex 7 of these Regulations.




20 April 2004

Preservatives Permitted in the Composition of Cosmetic Products and Restrictions on the Use thereof

No. Name of preservative

Restrictions on Use

maximum permitted concentration


Conditions of use and warnings which must be specified on the labelling


1 2 3 4 5 6

1. 3-acetil-6-metilpirān-2.4 (3H)-dions (dehidroetiķskābe) un tās sāļi

3-Acetyl-6-methylpyran-2.4 (3H)-dione (Dehydroacetic acid) and its salts

0.6 % (calculated as acid) Prohibited in aerosols

2. Alkil (C12-C22) trimetil-amonija bromīds un hlorīds(1)

Alkyl (C12-C22) trimethylammonium, bromide and chloride

0.1 %

3. Benzalkonija hlorīds, bromīds un saharināts (1)

Benzalkonium chloride, bromide and saccharinate

0.1% (calculated as benzalkonium chloride)

Avoid contact with the eyes

4. 1.6-di(4-amidīnfenoksi)-n-heksāns (heksamidīns) un tā sāļi (ieskaitot izetionātu un p-hidroksibenzoātu)(1)

1.6-Di(4-amidino-phenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate)

0.1 %

5. Benzetonija hlorīds Benzethonium chloride 0.1 % Permitted only in products intended to be rinsed off



Restrictions on Use





1 2 3 4 5 6

6. 2-benzil-4-hlorfenols (hlorofēns) 2-benzyl-4-chlorophenol (Chlorophene)

0,2 %

7. Benzilhemiformāls Benzylhemiformal 0.15 % Permitted only in products intended to be rinsed off

8. Benzilspirts (1) Benzyl alcohol 1 %

9. Benzoskābe, tās sāļi un esteri(1) Benzoic acid, its salts and esters 0.5 % (calculated as acid)

10. Bifenil-2-ols (o-fenilfenols) un tā sāļi(1)

Biphenyl-2-ol (o-phenylphenol) and its salts

0.2% (calculated as phenol)

11. 5-brom-5-nitro-1.3 dioksāns 5-Bromo-5-nitro-1.3 dioxane 0.1 % Permitted only in products intended to be rinsed off. Avoid formation of nitrosamines

12. Bronopols (INN)(1) Bronopol (INN) 0.1 % Avoid formation of nitrosamines

13. Cinka piritions (INN)(1) Pyrithione zinc (INN) 0.5 % Permitted only in products intended to be rinsed off.

Prohibited in products for oral cavity hygiene

14. 3.3’-dibrom-4.4’-heksametilēna dioksidibenzamidīns (dibromheksamidīns) un tā sāļi (ieskaitot izetionātu)

3.3’-Dibromo-4.4’-hexamethylene dioxydibenzamidine (Dibromohexamidine) and its salts (including isethionate)

0.1 %



Restrictions on Use





1 2 3 4 5 6

15. 1,2-dibrom-2.4-diciānbutāns (metildibromglutaronitrils)

1,2-Dibromo-2.4-dicyanobutane (methyldibromo glutaronitrile)

0.1 % Prohibited in cosmetic products intended for protection against the sun in concentrations exceeding 0.025% (3).

Permitted only in rinse-off products (4)

16. 6.6-dibrom-4.4-dihlor-2,2’-metilēndifenols (bromohlorofens)(1)

6.6-Dibromo-4.4-dichloro-2,2’-methylenediphenol (Bromochlorophen)

0.1 %

17. 2.4-dihlorbenzilspirts (1) 2.4-Dichlorobenzyl alcohol 0.15 %

18. 4.4-dimetil-1.3-oksazolidīns 4.4-Dimethyl-1.3-oxazolidine 0.1 % pH in finished products shall not be less than pH 6

19. 5-etil-3.7-dioksa-1-azabiciklo [3.3.0] oktāns

5-Ethyl-3.7-dioxa-1-aza-bicyclo [3.3.0] octane

0.3 % Prohibited in products for oral cavity hygiene and in products intended to come into contact with mucous membranes



Restrictions on Use





1 2 3 4 5 6

20. Fenildzīvsudraba sāļi (ieskaitot borātu)

Phenylmercuric salts (including borate)

0.007% of mercury.

When mixed with other mercury compounds permitted by these Regulations, maximum mercury concentration in the final product shall not exceed 0.007%

Permitted only in eye make-up and eye make-up removers

Contains phenylmercuric compounds

21. 2-fenoksietanols(1) 2-Phenoxyethanol 1 %

22. 1-fenoksipropān-2-ols 1-Phenoxypropan-2-ol 1 % Permitted only in cosmetic products that must be rinsed off after use

23. Formaldehīds un paraformaldehīds Formaldehyde and paraformaldehyde

0.2% (except in products for oral cavity hygiene);

0.1% (in products for oral cavity hygiene), calculated as free formaldehyde

Prohibited in aerosols

24. Glutāraldehīds (pentān-1.5-diāls) Glutaraldehyde (Pentane-1.5-dial) 0.1 % Prohibited in aerosols Contains glutaraldehyde (if concentration of glutaraldehyde in finished products exceeds 0.05%)

25. Heksametilēntetramīns(1)

(metenamīns) (INN)Hexamethylenetetramine (methenamine) (INN)

0.15 %



Restrictions on Use





1 2 3 4 5 6

26. Heksetidīns (INN)(1) Hexetidine(INN) 0.1 %

27. 1-hidroksi-4-metil-6(2.4.4-trimetilpentil) 2-piridons un tā monoetanolamīna sāls(1)

1-Hydroxy-4-methyl-6(2.4.4-trimethylpentyl) 2-pyridon and its monoethanolamine salt

1) 1 %; 1) Permitted only in cosmetic products that must be rinsed off after use;

2) 0.5 % 2) in other products

28. 4-hidroksibenzoskābe un tās sāļi un esteri(1)

4-Hydroxybenzoic acid and its salts and esters

0.4% (calculated as acid) for 1 ester;

0.8% (calculated as acid) for ester compounds

29. 1.3-bis(hidroksimetil)-5.5-di-metilimidazolidīn-2.4-dions(1)

1.3-Bis(hydroxymethyl)-5.5-dimethylimi-dazolidine-2.4-dione

0.6 %

30. N-(hidroksimetil)-N-(dihidroksimetil-1.3-diokso-2.5-imidazolinidil-4)-N’-(hidroksimetil) urīnviela

N-(Hydroxymethyl)-N-(dihydroxymethyl-1.3-dioxo-2.5-imidazolinidyl-4)-N’-(hydroxymethyl) urea

0.5 %

31. 3.3’-bis (1-hidroksi-metil-2.5 dioksoimidazolidīn-4-il)-1.1-metilēndiurīnviela ("Imidazolidinilurīnviela")(1)

3.3’-Bis(1-hydroxy-methyl-2.5 dioxoimida-zolidin-4-yl)-1.1-methylenediurea ("Imidazolidinylurea")

0.6 %



Restrictions on Use





1 2 3 4 5 6

32. 5-hlor-2-metilizotiazol-3(2H)-ona un 2-metilizotiazol-3(2H)-ona maisījums ar magnija hlorīdu un magnija nitrātu

Mixture of 5-Chloro-2-methylisothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate

0.0015 (proportion 3:1 from 5-chloro-2-methylisothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one mixture)

33. 4-hlor-3.5-ksilenols(1) 4-Chloro-3.5-xylenol 0.5 %

34. 2-hloracetamīds 2-Chloroacetamide 0.3 % Contains chloroacetamide

35. Hlorbutanols (INN) Chlorobutanol (INN) 0.5 % Prohibited in aerosols Contains chlorobutanol

36. 1-(4-hlorfenoksi)-1-(imidazol-1-il)-3.3-dimetilbutān-2-ons(1)

1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3.3-dimethylbutan-2-one

0.5 %

37. 3-(p-hlorfenoksi)-propān-1,2 diols (hlorfenezīns)

3-(p-Chlorphenoxy)-propane-1,2 diol (chlorphenesin)

0.3 %

38. Hlorheksidīns (INN) un tā diglikonāts, diacetāts un dihidrohlorīds(1)

Chlorhexidine (INN) and its digluconate, diacetate and dihydrochloride

0.3% (calculated as chlorhexidine)

39. 4-hlor-m-krezols(1) 4-Chloro-m-cresol 0,2 % Prohibited in cosmetic products intended to come into contact with mucous membranes

40. 4-izopropil-m-krezols 4-Isopropyl-m-cresol 0.1 %



Restrictions on Use





1 2 3 4 5 6

41. 3-jod-2-propinilbutilkarbamāts 3-Iodo-2-propynylbutylcarbamate 0.05 % 1) prohibited in products for oral cavity hygiene and in cosmetic products intended for lipcare;

2) if the concentration thereof in a cosmetic product not intended to be removed from the skin exceeds 0.02 %, the following must be indicated: “Satur jodu” [contains iodine]

Contains iodine

42. Metenamīna 3-hloralilhlorīds (INNM) Methenamine 3-chloroallylochloride (INNM)

0,2 %

43. Nātrija hidroksimetilamino acetāts (nātrija hidroksime-tilglicināts)

Sodium hydroxymethylamino acetate (Sodium hydroxymethylglycinate)

0.5 %

44. Sodium iodate Sodium iodate 0.1 % Permitted only in cosmetic products that must be rinsed off after use

45. Neorganiskie sulfīti un hidrogēnsulfīti(1)

Inorganic sulphites and hydrogensulphites

0.2% (calculated as free sulphur dioxide)

46. Poli (1-heksametilēnbiguanidīna) hidrohlorīds(1)

Poly (1-hexamethylenebiguanide) hydrochloride

0.3 %

47. Propionskābe un tās sāļi(1) Propionic acid and its salts 2 % (calculated as acid)



Restrictions on Use





1 2 3 4 5 6

48. Salicilskābe un tās sāļi(1) Salicylic acid and its salts 0.5 % (calculated as acid) Prohibited in cosmetic products for children under three years of age, except in shampoos

Prohibited in cosmetic products intended for children under three years of age (2)

49. Skudrskābe un tās nātrija sāls(1) Formic acid and its sodium salt 0.5 % (calculated as acid)

50. Sorbīnskābe (heksa-2.4-diēnskābe) un tās sāļi(1)

Sorbic acid (hexa-2.4-dienoic acid) and its salts

0.6 % (calculated as acid)

51. Sudraba hlorīda nogulsnes uz titāna dioksīda

Silver chloride deposited on titanium dioxide

0.004% (calculated as silver chloride)

20% silver chloride on titanium dioxide.

Prohibited in cosmetic products intended for children under three years of age, in products for oral cavity hygiene, and in products intended for use in the vicinity of the eyes and on the lips

52. Tiomersals (INN) Thiomersal (INN) 0.007% of mercury.

When mixed with other mercury compounds permitted by these Regulations, maximum mercury concentration in the final product must not exceed 0.007%

Permitted only in eye make-up and eye make-up removers

Contains thiomersal



Restrictions on Use





1 2 3 4 5 6

53. Triklokarbāns (INN)(1) Triclocarban (INN) 0,2 % Purity criteria: 3.3’.4.4’ – tetrachlormethane < 1 mg/kg;

3.3’.4.4’ – tetrachlorazoxybenzene< 1 mg/kg;

54. Triklosāns (INN)(1) Triclosan (INN) 0.3 %

55. Undek-10-enoīnskābe un sāļi(1) Undec-10-enoic acid and salts 0.2 % (calculated as acid)

Notes.1. The substance under Reference (1) may be added to a cosmetic product in a concentration that differs from the concentration specified in this Annex if it is being utilised for other specific purposes regarding which there is a reference in the labelling of the cosmetic product, for example, as a deodorant in soaps or as an antidandruff agent in shampoos. 2. The warning under Reference (2) must be specified only in the labelling of such cosmetic product which may be utilised on children under three years of age and which remains in prolonged contact with the skin. 3. The restriction on the use of an ingredient under Reference (3) applies to cosmetic products, which have been manufactured in or imported into the European Union before 23 March 2005. Such products may be offered for sale to a final consumer not longer than until 23 September 2005.4. The restriction on use of an ingredient under Reference (4) applies to the cosmetic products, which have been manufactured in or imported into the European Union as of 24 March 2005.5. Cosmetic products also have other substances used therein, which have antimicrobiological properties that function as preservatives of the final product, for example, most essential oils and some spirits. Such substances are not included in this Annex. 6. Within the meaning of this Annex, the salts and esters are:6.1. salts - sodium, potassium, calcium, magnesium, ammonium, and ethanolamine cation salts, chloride, bromine, sulphate, acetate anion salts; and


6.2. esters - methyl-, ethyl-, propyl-, isopropyl-, butyl-, isobutyl-, phenylesters.7. If a cosmetic product contains formaldehyde or substances that are referred to on this list and that release formaldehyde in the finished product in concentrations exceeding 0.05%, the labelling must bear the warning “Satur formaldehīdu” [Contains formaldehyde].




20 April 2004 Ultraviolet Radiation Filters which are Permitted to be Included in the Composition of Cosmetic Products and Restrictions for the Use thereof

No.Name of ultraviolet radiation filter

Restrictions on Use


Conditions of use and warnings which must be specified on the labellingin Latvian in English

1 2 3 4 5

1. 4-aminobenzoskābe 4-Aminobenzoic acid 5 %

2. 3-benzilidīnkampars 3-Benzylidene camphor 2 %

3. Benzoskābes 4.4-((6-(((1.1-dimetiletil) aminokarbonil) fenilamino)-1.3.5-triazīn-2.4-diil) diimino)bis-,bis-(2-etilheksil) esteris

Benzoic acid, 4.4-((6-(((1.1-dimethylethyl) aminocarbonyl) phenylamino)-1.3.5-triazine-2.4-diyl) diimino)bis-,bis-(2-ethylhexyl) ester (CAS No 154702-15-5)

10 %

4. 2-(2H-benzotriazol-2-il)-4-metil-6-(2-metil-3-(1.3.3.3-tetra-metil-1-(trimetilsilil)oksi)-disilo-ksanil)propilfenols (drometrizola trisiloksāns)

Phenol, 2-(2H-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1.3.3.3-tetra-methyl-1-(trimethylsilyl)oxy)-disilo-xanyl)propyl (Drometrizole Trisiloxane)

15 %

5. 2-ciān-3.3-difenil akrilskābes 2-etilheksilesteris (oktokrilēns)

2-Cyano-3.3-diphenyl acrylic acid, 2-ethylhexyl ester (Octocrylene)

10 % (calculated as acid)

6. Dimetikodietilbenzalmalonāts Dimethicodiethylbenzalmalonate (CAS No 207574-74-1)

10 %

7. 2-2’-bis-(1.4-fenilēn)1H-benzimidazol-4.6-disulfoskābes mononātrija sāls

Monosodium salt of 2-2’-bis-(1.4-phenylene)1H-benzimidazole-4.6-disulphonic acid




Restrictions on Use



1 2 3 4 5

8. Etil-2-heksil 4-dimetilami-nobenzoāts (oktil dimetil PABA)

4-Dimethyl-amino-benzoate of ethyl-2-hexyl (octyl dimethyl PABA)

8 %

9. 2-etilheksilsalicilāts (oktilsalicilāts) 2-Ethylhexyl salicylate (Octyl salicylate) 5 %

10. Etoksilēts etil-4-aminobenzoāts

(PEG-25 PABA)

Ethoxylated Ethyl-4-Aminobenzoate

(PEG-25 PABA)

10 %

11. 2-fenilbenzimidazol-5-sulfoskābe un tās kālija, nātrija un trietanolamīna sāļi

2-Phenylbenzimidazole-5-sulphonic acid and its potassium, sodium and triethanolamine salts


12. 3.3’-(1.4-fenilēndimetilēn) bis (7.7-dimetil-2-oksobiciklo-[2,2.1]hept-1-ilmetānsulfoskābe) un tās sāļi

3.3’-(1.4-Phenylenedimethylene) bis (7.7-dimethyl-2-oxobicyclo-[2,2.1]hept-1-yl-methanesulphonic acid) and its salts


13. 2-hidroksi-4-metoksibenzofenon-5-sulfoskābe (Benzofenons-5) un tās nātrija sāls

2-Hydroxy-4-methoxy-benzophenone-5-sulphonic acid (Benzophenone-5) and its sodium salt


14. Homosalats Homosalate (INN) 10 %

15. Izopentil-4-metoksicinamāts (izoamil-p-metoksicinamāts)

Isopentyl-4-methoxycinnamate (Isoamyl p-Methoxycinnamate)

10 %

16. 3-(4’-metilbenzilidīn)-d-1-kampars

(4-metilbenzilidīnkampars)

3-(4’-Methylbenzylidene)-d-1-camphor (4-Methylbenzylidene Camphor)

4 %



Restrictions on Use



1 2 3 4 5

17. Oksibenzons (INN) Oxybenzone (INN) 10 % Contains oxybenzone

(A warning need not be indicated if the concentration of oxybenzone is 0.5% or less and it is utilised only for the protection of the product itself

18. N-{(2 un 4)-[(2-oksoborn-3-iliden)metil]benzil}akrilamīda polimērs

Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl}acrylamide

6 %

19. 2,2’-metilēn-bis-6-(2H-benzotriazol-2il)-4-(tetrametil-butil)-1.1.3.3-fenols

2,2’-Methylene-bis-6-(2H-benzotriazol-2yl)-4-(tetramethyl-butyl)-1.1.3.3-phenol

10 %

20. alfa-(2-oksoborn-3-ilidēn)-toluol-4-sulfoskābe un tās sāļi

alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts

6% (calculated as acid)

21. Oktil metoksicinamāts Octyl methoxycinnamate 10 %

22. 1-(4-terc-butilfenil)-3-(4-metoksifenil)propān-1.3-dions

1-(4-tert-butylphenyl)-3-(4-methoxyphenyl)propane-1.3-dione

5 %

23. Titāna dioksīds Titanium dioxyde 25 %

24. 2.4.6-trianilīn-(p-karbo-2’-etilheksil-1’-oksi)-1.3.5-triazīns (Oktiltriazons)

2.4.6-Trianilino-(p-carbo-2’-ethylhexyl-1’-oxy)-1.3.5-triazine (Octyl Triazone)

5 %

25. (1.3.5)-triazīna-2.4-bis ((4-(2-etil-heksiloksi)-2-hidroksi)-fenil)-6-(4-metoksifenils)

(1.3.5)-Triazine-2.4-bis((4-(2-ethyl-hexyloxy)-2-hydroxy)-phenyl)-6-(4-methoxyphenyl)

10 %

26. N,N,N-trimetil-4-(2-oksoborn-3-ilidēnmetil) anilīna metilsulfāts

N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate

6 %


Veselības ministrs R. Muciņš



20 April 2004

Methods for Determining Toxicity and Other Health Effects

1. bis Acute toxicity (internally) – the specified (fixed) dose method.2. tris Acute toxicity (orally) – the acute toxic class method.3. Acute toxicity (through inhaling). 4. Acute toxicity (dermally).5. Acute toxicity (skin irritation).6. Skin sensitization.7. Repeated dose (28 days) toxicity (orally). 8. Repeated dose toxicity (through inhaling). 9. Repeated dose (28 days) toxicity (dermally). 10. Mutagenicity – test of mammal chromosome changes in vitro.11. Mutagenicity – test of mammal bone marrow chromosome changes in vivo.12. Mutagenicity – micronucleus test of mammal erythrocyte in vivo.13./14. Mutagenicity – reverse mutation test utilising bacterium.15. Gene mutations – Saccharomyces cerevisiae.16. Mitotic recombinations – Saccharomyces cerevisiae.17. Mutagenicity – gene mutation test of mammal cells in vitro.18. DNA damage and renewal – unplanned DNA synthesis process – in mammal cells in vitro.19. Sister chromatid exchange examination in vitro.20. Examination of the recessive lethal factor related to gender on flies Drosophila melanogaster. 21. in vitro transformation examination of mammal cells.22. Examination of the dominating lethal factor in rodents.23. Test of changes in the spermatogonial chromosomes of mammals.24. Mouse spot test.25. Mouse inherited translocation.26. Sub-chronic oral toxicity test. 90-day repeated dose toxicity investigations utilising rodents.27. Sub-chronic oral toxicity test. 90-day repeated dose toxicity investigations without utilising rodents.28. Sub-chronic dermal toxicity examinations. 90-day repeated dose investigations on the skin utilising rodent species.29. Sub-chronic toxicity inhalation examinations: 90-day repeated inhaled dose toxicity investigations utilising rodent species.30. Chronic toxicity test.31. Teratogenicity examinations – on rodents and others (non-rodents).32. Carcinogenicity test.33. Combined chronic toxicity/carcinogenicity test.34. One-generation reproductive toxicity test.35. Two-generation reproductive toxicity test.36. Toxicokinetics.37. Delayed neurotoxicity of phosphorganic compounds following an acute exposure.


38. Repeated dose examinations (28 days) of the delayed neurotoxicity of organophosphorus compunds.39. Unscheduled DNA synthesis (UDS) test with mammal liver cells in vivo.40. Skin corrosion.41. Phototoxicity – in vitro 3T3 NRU phototoxicity test.




20 April 2004

Techniques for Detecting Chemical Substances Contained in Cosmetic Products (National Standards)

No. Name of the chemical substanceDetection technique

(LSS number)

1 2 3

1. Ammonia LSS 391:2001

2. AlumīnijsAluminum LSS 393:2001

3. Benzyl alcohol LSS 393:2001

4. Benzil-4-hidroksibenzoātsBenzyl-4-hydroxylunzoate LSS 395:2001

5. Benzoic acid LSS 394:2001

6. Bis(8-hidroksihinolīnija) sulfāts?? LSS 391:2001

7. Free formaldehyde LSS 390:2001

8. Free potassium hydroxide LSS 389:2001

9. Free sodium hydroxide LSS 389:2001

10. Butyl 4-hydroxybenzoate LSS 395:2001

11. Zinc LSS 389:2001

12. Zirconium LSS 393:2001

13. Dibromohexamidine LSS 393:2001

14. Dibromopropamidine LSS 393:2001

15. Dichloromethane LSS 391:2001

16. Mercury organic compounds LSS 391:2001

17. Ethyl 4-hydroxybenzoate LSS 395:2001

18. 2-phenoxyethanol LSS 395:2001

19. 1-phenoxypropan-2-ol LSS 395:2001

20. Phenolsulfonic acid LSS 389:2001

21. Glycerol 1-(4-aminobenzoate) LSS 392:2001

22. Hexachlorophene LSS 391:2001

23. Hexamidine LSS 393:2001

24. Hydroquinone monobenzylether LSS 394:2001

25. Hydroquinone monomethylether LSS 394:2001

26. Hydroquinone LSS 394:2001

27. 4-hydroxybenzoic acid LSS 394:2001

28. Quinine LSS 392:2001Translation © 2004 Tulkošanas un terminoloģijas centrs (Translation and Terminology Centre) 108


(LSS number)

1 2 3

29. Quinoline LSS 391:2001

30. Chlorobutanol LSS 392:2001

31. Chlorhexidine LSS 393:2001

32. Chloroform LSS 389:2001

33. Chlorine LSS 393:2001

34. Total fluorine LSS 391:2001

35. Mercaptoacetic acid LSS 391:2001

36. Methanol (in releation to ethanol or isopropanol) LSS 390:2001

37. Methyl 4-hydroxybenzoate LSS 395:2001

38. Sodium iodate LSS 392:2001

39. Neorganiskie hidrogēnsulfītiInorganic hudrogensulphites LSS 392:2001

40. Neorganiskie sulfītiInorganic sulphites LSS 392:2001

41. Nitrites LSS 390:2001

42. Nitromethane LSS 391:2001

43. Oxidation colorants LSS 390:2001

44. Oxidisers LSS 390:2001

45. Propyl benzyl 4-hydroxybenzoate LSS 395:2001

46. Propionic acid LSS 394:2001

47 Resorcinol LSS 390:2001

48. Salicylic acid LSS 394:2001

49. Chlorates of alkali metals LSS 392:2001

50. Sulphides of alkali metals LSS 391:2001

51. Alkaline earth sulphides LSS 391:2001

52. Selenium disulphide LSS 393:2001

53. Oxalic acid LSS 389:2001

54. Alkali metal salts of oxalic acid LSS 389:2001

55. Sorbic acid LSS 394:2001

56. Silver nitrate LSS 393:2001

57. Šķīstošie bārija savienojumiSoluble barium compound LSS 393:2001

58. Soluble strontium compounds LSS 393:2001

59. Sodium salts of tosyl acid LSS 391:2001

60. 1.1.1-trichlorethane LSS 391:2001



(LSS number)

1 2 3

61. Hydrogen peroxide LSS 390:2001




20 April 2004

Microbiological Purity Criteria for Cosmetic Products and Methods for the Ascertainment thereof

I. Microbiological Purity Criteria for Cosmetic Products

No. Category of cosmetic product

Quantity of aerobic mesophilic

microorganisms

(KVV or ml)(1)

Stafilococcus aureus Pseudomonas aeruginosa Candida albicans

1 2 3 4 5 6

1. Cosmetic products intended for children under three years of age, for use in the vicinity of the eyes and on mucous membranes

not more than 102

0.5 g (0.5 ml) presence in a cosmetic product

0.5 g (0.5 ml) presence in a cosmetic product is not permitted



2. Other cosmetic products not more than 103

0.1 g (0.1 ml) presence in a cosmetic product




II. Microbiological Testing Methods of Cosmetic Products

1. Growth media and reagents:1.1. solvent: Sodium chloride-peptone buffer solution pH 7.0

potassium dihydrogen phosphate 3.56 g equivalent up to 0.067 Mnātrija hidrogēnfosfāts, bezūdens 7.23 g

sodium chloride 4.30 g

peptone (meat or casein) 1.0 g

distilled water 1.000 ml

Sterilisation is performed by menas of autoclave at a temperature of 121 °C for 15 minutes. Where required, relevant neutralising substances, for example, polysorbate 20 or 80, lecithin, thiosulphate shall be added;

1.2. culture medium for the determination of the number of bacteria: Soy agar hydrolysed with casein

casein hydrolysed with pancreatin 15.0 gTranslation © 2004 Tulkošanas un terminoloģijas centrs (Translation and Terminology Centre) 111

soya bean hydrolysed with papain 5.0 g

sodium chloride 5.0 g

agar 15.0 g


pH shall be regulated so as to ensure that after sterilisation it is 7.3 +/– 0.2. Sterilisation shall be performed by means of autoclave at a temperature of 121 °C for 15 minutes;

1.3. culture medium for the determination of the number of fungi and Candida albicans: Saburo-dextrose agar

peptone (meat and casein) 10.0 g

dextrose monohydrate 40.0 g

agar 15.0 g


pH shall be regulated so as to ensure that after sterilisation it is 5.6 +/– 0.2. Sterilisation shall be performed by means of autoclave at a temperature of 121°C for 15 minutes.

1.4. culture medium for the determination of Pseudomonas aeruginosa: Cetrimide agar

gelatine hydrolysed with pancreatin 20.0 g

magnesium chloride 1.4 g

potassium sulphate 10.0 g

cetrimide 0.3 g

agar 13.6 g


glycerol 10.0 ml

pH shall be regulated so as to ensure that after sterilisation it is 7.2 +/– 0.2. Sterilisation shall be performed by means of autoclave at a temperature of 121°C for 15 minutes

1.5. culture medium for the determination of Staphylococcus aureus: Baird Parker agar

casein hydrolysed with pancreatin 10.0 g

beef extract 5.0 g

yeast extract 1.0 g

lithium chloride 5.0 g

agar 20.0 gTranslation © 2004 Tulkošanas un terminoloģijas centrs (Translation and Terminology Centre) 112

glycine 12.0 g

sodium pyruvate x 10.0 g

distilled water 950 ml

pH shall be regulated so as to ensure that after sterilisation it is 6.8 +/– 0.2. Sterilisation shall be performed by means of autoclave at a temperature of 121°C for 15 minutes, cooling shall be performed to 45-50 °C and 10 ml of sterile 1% m/V(2) potassium tellurite solution and 50 ml egg yolk emulsion shall be added;

2. Preparation of samples.For the performance of microbiological examinations at least 1 g or 1 ml of a sample shall be taken. If the weight of the sample of a product is less than 1 g, several samples shall be combined so as to obtain 1 g or 1 ml in total. 1 g or 1 ml shall be dissolved in or diluted with neutralised solvent in order to obtain a tenfold dilution. If it is difficult to moisten substances, an appropriate surface active substance shall be used, for example, 0.1 % m/V (2) polysorbate 80 shall be added. Where required, tenfold serial dilutions of suspensions of raw materials may be united, by using the same solvent in order to suppress the anti-microbial activity of the product so that the number of colonies could be from 10 to 100.

3. Determination of the viable mesophilic aerobic micro-organisms:3.1. membrane filtering:

two membrane filters shall be used with a pore size of not more than 0.45 mm, which effectively hold the bacteria. The method presumes that membranes with 50 mm in diameter shall be used. The amount that corresponds 0.1 g of the product to be examined per each membrane shall be dislocated and filtered immediately. Rinsing with a sterile washing solution shall follow. It shall facilitate an even division of micro-organisms. Membranes shall be moved to the relevant agar growth media. Bacteria shall be incubated at 30-35 °C for three days and fungi shall be incubated at 20-25 °C for five days, unless a much more reliable amount is obtained within a shorter period of time. The colonies, which have developed, shall be counted. The number of micro-organisms in a gram or millilitre of the product to be examined shall be calculated;

3.2. The Petri dish method:when using Petri dishes of 9 to 10 cm in diameter, each dish shall have 1 ml of the prepared sample added thereto, which corresponds to 0.1 g of the product, and to about 15 ml agar growth media, correspondingly melted at not more than 45 °C. It shall be mixed and kept on a cold horizontal surface until it hardens. The dissolved solution shall be alternatively dispersed on the surface of a corresponding hardened growth media in a Petri dish 9-10 cm in diameter (usually 0.1 ml on a dish which corresponds to 0.01 g of the product). Bacteria shall be incubated at 30-35 °C for three days and fungi shall be incubated at 20-25°C for five days, unless a much more reliable amount is obtained within a shorter period of time. The developed colonies shall be counted. The result shall be calculated by using the dishes with the largest number of colonies, but not more than 300 colonies for bacteria and 100 colonies for fungi;

3.3. expression of results:the number of colony-forming units (CFU) for each dish shall be counted and recorded in the report. The total number of CFU for each dish shall be calculated and this number shall be multiplied by the dilutions, thus obtaining the result CFU per 1 g or per 1 ml of the product.


4. Determination of specific micro-organisms.4.1. Determination of Pseudomonas aeruginosa:

on the cetrimide culture medium the typical Pseudomonas aeruginosa colonies look flat, transparent, jade to blue. At least the following tests must be performed:

4.1.1. colouring by Gram;4.1.2. oxidase test;4.1.3. mobility;4.1.4. growth ability at 42°C .

Pseudomonas aeruginosa is a gram-negative rod, aerobic, oxidase positive and grows at 42°C(3);

4.2. Determination of Staphylococcus aureus.On Baird-Parker growth media the typical Staphylococcus aureus colonies look black, shiny, curved and enclosed (encircled) by a transparent zone which may be partly non-transparent. At least the following conformity tests must be performed:

4.2.1. colouring by Gram;4.2.2. catalase test;4.2.3. coagulase test;

Gram-positive cocci, catalase or coagulase may be indicative of Staphylococcus aureus(3);4.3. Determination of Candida albicans.

on Saburo-dextrose growth media typical Candida albicans look white to beige (cream-coloured), curved. At least the following conformity tests must be performed:

4.3.1. microscopy;4.3.2. germination; and 4.3.3. formation of chlamidospores.

Germinated yeast and formation of chlamidospores may be an indicator of Candida albicans(3);

4.4. expression of results.The results shall be recorded in a test report, specifying the presence or absence of micro-organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans).

Notes.(1) CFU - colony-forming units(2) m/V – 0.1 g/100 ml(3) In order to certify identity, other corresponding additional tests must be used.




20 April 2004

Sample of the Symbol for the Labelling of the Expiration Date of Cosmetic Products

Note. Dimensions of the symbol are not specified.

Minister for Health R Muciņš



20 April 2004

Sample of the Symbol for the Notice of Additional Information regarding the Cosmetic Product

Note. Dimensions of the symbol are not specified. The symbol shall be in two contrasting colours.




20 April 2004

Information for the Cosmetic Products Database regarding an Undertaking and Responsible Person

1. Information regarding a legal person. With regard to the cosmetic products, the undertaking is the (mark the appropriate with X)

producerprime importerdistributor in Latvia

namethe number of the registration certificate of the undertaking in the Commercial Registerlegal addresstelephonefaxe-mail addressactual addresstelephonefaxe-mail address

2. Information regarding persons who are competent and entitled to provide to the State Sanitary Inspection with the necessary information regarding the cosmetic products.The person responsible for the (mark the appropriate with X)

production of the cosmetic productsfirst importation of the cosmetic productsdistribution in Latvia of the cosmetic products

given name, surnamepersonal identity numberpositionaddress of the place of worktelephonefaxe-mail address


Additional contact person given name, surnamepersonal identity numberpositionaddress of the place of worktelephonefaxe-mail address

3. AuthorisationI authorise the referred to responsible person and the additional contact person to provide to the State Sanitary Inspection the information specified in regulatory enactments regarding cosmetic products offered on the Latvian market.

I undertake to notify the State Sanitary Inspection regarding any changes in the information specified not later than within a time period of five days.

This document has been drawn up in two copies.

Date _______________________________

Head of the undertaking _____________________________________(signature and full name)

Place for a seal

_______________________________________________________________________

To be filled by an official of the State Sanitary Inspection

Database registration No. - - -

Official of the State Sanitary Inspection ____________________________________(position, signature and full name)

Date __________________




20 April 2004

Information for the Database of Cosmetic Products regarding Cosmetic Products Offered on the Market in the Republic of Latvia (the Qualitative and Quantitative Composition thereof)

Information registration No.

Responsible expert

(for official use) (to be filled by the official of the State Sanitary Inspection)

Name of undertaking Total amount of information pages

Number of attached annexes

Database registration No.

Date of submission of the information

Signature of the submitter of the information

Given name, surname, position

of the submitter of the information ____________________________

Place for a seal


Information regarding the Cosmetic Product

No.Trademark 1) Name 1) Number of the

basic type2) Type, usage

The start date of offering on the market in

the Republic of Latvia

Name, address of the producer

State of manufacture

Qualitative and quantitative

composition (No. of the annex) 3)

Environmental pH 4)

Place (address) of

first importation 5)

Notes

1 2 3 4 5 6 7 8 9 10 11 12

Notes.1) Specified in the original language.2) The number of basic types of relevant cosmetic products, which has been specified in Annex 1 of these Regulations, shall be indicated.3) Information regarding the qualitative (according to INCI) and quantitative (% of mass) composition of a cosmetic product shall be a certified copy of a document issued by the producer which shall be attached as a numbered annex to this information regarding the relevant cosmetic product. The number of the annex shall be specified in Column 9 of the Table. The producer may provide information regarding the composition of a cosmetic product also in accordance with the standard prescriptions developed by the European Association of Poisons Centres and Clinical Toxicologists EAPCCT and the European Cosmetic Toiletry and Perfumery Association COLIPA (Cosmetic Frame Formulations, EAPCCT/COLIPA, January 2000). 4) Environmental pH must be specified if the environmental pH of a cosmetic product is below pH 3 or above pH 10.5) To be completed only for cosmetic products which have not been produced in the European Union.

Information for the database of cosmetic products offered on the market in the Republic of Latvia shall be submitted to the State Sanitary Inspection in documentary form in two copies as well as electronically.

