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SICC

AGGIORNAMENTO

LEGISLATIVO 2015

LA GESTIONE DEI PRODOTTI BORDERLINE NELL’UNIONE EUROPEA

Stefano Dorato

Cosmetica Italia

Direttore Relazioni Scientifiche

e Normative

Milano, 3 Dicembre 2015

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PRODOTTI BORDERLINE Il mio prodotto è (ancora) un cosmetico ?

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PRODOTTI BORDERLINE Sometimes it may be unclear whether a particular product is a cosmetic product under cosmetics legislation or whether it falls under other sectorial legislation. In the case of these “borderline products”, the decision on a product’s classification must be taken on a case-by-case basis. The European Commission has published guidance documents to facilitate the application of EU legislation in these cases. They include a “manual” on the application of Article 2 of the Cosmetics Regulation, i.e. the definition of a “cosmetic product” and the various guidelines on the borderline between cosmetics legislation and other sectorial legislation. http://ec.europa.eu/growth/sectors/cosmetics/products/borderline-products/index_en.htm

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PRODOTTI BORDERLINE Manual on the scope of application of the Cosmetics Regulation (EC) No 1223/2009 (Art. 2(1)(a)) (V. 10 November 2013) (178 kB)

Guidance Document on the relationship between the General Product Safety Directive (GPSD) and certain sector directives with provisions on product safety (500 kB)

Manual of decisions for implementation of Directive 98/8/EC concerning the placing on the market of biocidal products (450 kB)

Guidance Document on the demarcation between the Cosmetic Products Directive 76/768 and the Medicinal Products Directive 2001/83 (66 kB)

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PRODOTTI BORDERLINE

Manual on the scope of application of the Cosmetics Regulation (EC) No. 1223/2009 (Art. 2(1)(a))

Version 10 (November 2013).

PLEASE NOTE: THE VIEWS EXPRESSED IN THIS MANUAL ARE NOT LEGALLY BINDING; ONLY THE EUROPEAN COURT OF JUSTICE (“COURT”) CAN GIVE AN AUTHORITATIVE INTERPRETATION OF COMMUNITY LAW.

• MOREOVER, THIS MANUAL SHALL ONLY SERVE AS “TOOL” FOR THE CASE-BY-CASE APPLICATION OF COMMUNITY-LEGISLATION BY THE MEMBER-STATES. IT IS FOR THE NATIONAL COMPETENT AUTHORITIES AND NATIONAL COURTS TO ASSESS ON A CASE-BY-CASE BASIS WHICH REGULATORY FRAMEWORK APPLIES.

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PRODOTTI BORDERLINE

• THE CONTENT OF THIS MANUAL AND ALL UPDATES ARE PRESENTED TO THE WORKING GROUP ON COSMETIC PRODUCTS FOR CONSULTATION. THIS GROUP IS CHAIRED BY THE COMMISSION AND IS COMPOSED OF REPRESENTATIVES OF ALL MEMBER STATES OF EU AND EFTA, THE EUROPEAN ORGANISATION OF CONSUMERS (BEUC), THE EUROPEAN FEDERATION OF COSMETIC PRODUCTS (COLIPA), THE EUROPEAN FEDERATION FOR COSMETIC INGREDIENTS (EFFCI), THE INTERNATIONAL FRAGRANCE ASSOCIATION (IFRA), THE EUROPEAN ORGANISATION OF COSMETIC INGREDIENTS INDUSTRIES AND SERVICES (UNITIS), AND THE EUROPEAN ASSOCIATION OF CRAFT, SMALL AND MEDIUM SIZED ENTERPRISES (UEAPME).

PRODOTTI BORDERLINE

Tre criteri fondamentali per classificare un prodotto:

• forma chimico-fisica

• sito di applicazione indicato

• funzione primaria

+ la presentazione in generale del prodotto (es. etichetta, claim, ecc.)

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•Farmaci

•Dispositivi medici

•Biocidi

•Giocattoli

•Alimenti

•Sostanze chimiche

Quali sono i più importanti VICINI dei cosmetici ?

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PRODOTTI BORDERLINE

1. Type of Product – Substance or Mixture

2. Application site

3. Intended Cosmetic Purpose

3.1. Borderline with Toys

3.1.1. Products which, according to their presentation, are destined to be used as make-up on dolls

3.1.2. Products which, according to their presentation, are destined to be used as make-up on children

3.1.3. Bath Products for Children with a Play Value

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PRODOTTI BORDERLINE

3.2. Borderline with Biocides

3.2.1. Leave-on products presented as “antiseptic” or “antibacterial”

3.2.2. "Antiseptic" or "Anti-bacterial" Mouthwash

3.3. Borderline with Pharmaceutical Products

3.3.1. Products which, according to their presentation, are intended to exclusively or mainly relieve joint pain

3.3.2. Products which, according to their presentation, are intended to address “itching”

3.3.3. Product containing substances which restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action

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PRODOTTI BORDERLINE

3.3.4. Products containing substances stimulating hair growth or reducing hair loss

3.3.5. Products that make eyelashes grow

3.3.6. Products for in-grown hairs

3.3.7. Products that make the lips swell

3.3.8. Products reducing cellulite

3.3.9. Substances applied with skin-patches

3.3.10. Products delivered through iontophoresis or similar mechanisms

3.3.11. Product to treat dry mouth

3.3.12. Products for superficial moisturizing of female genital organ in cases of extreme mucosal dryness

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PRODOTTI BORDERLINE 3.3.13. Topical breast augmentation products

3.3.14. Products claiming aromatherapy

3.3.15. Products for atopic skin

3.3.16. Products to reduce dark circle under the eyes, bruises or blue spots

3.3.17. Skin-whitening products

3.3.18. Products to relieve tired swollen and heavy legs

3.3.19. Anti-wrinkle products

3.4. Borderline with Medical Devices

3.4.1. Products which, according to their presentation, are intended to peel the skin

3.4.2. Products against head lice

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PRODOTTI BORDERLINE

3.5. Borderline with Other Legislations

3.5.1. Products which, according to their presentation, are defined to be used to detect plaque on teeth

3.5.2. Products which, according to their presentation, are destined to remove glue used to fix articles on the skin cosmetic products

3.5.3. Products which, according to their presentation, are intended to stimulate sexual activity

3.5.4. Cosmetic kits

PRODOTTI BORDERLINE

I cosmetici devono essere sostanze o miscele. Gli articoli non sono cosmetici anche se applicati sulla cute per svolgere un’azione cosmetica. Le sostanze o le preparazioni rilasciate intenzionalmente da un articolo possono essere cosmetici (ad es. un detergente applicato con un wet wipe). L’articolo può essere considerato un ”applicatore” del cosmetico e ricade nei disposti della normativa sulla sicurezza generale dei prodotti.

Cosmetics/Medicinal Products BORDERLINE - ALCUNI ESEMPI

Wigs False eyelashes Hair extensions

Cosmetic Wipes + Cosmetic Patches + Clothes releasing cosmetics + possibly Tattoos Slimming pills Nutro-cosmetics Tooth whitener injected in tooth

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PRODOTTI BORDERLINE

La funzione principale od esclusiva (funzione primaria) dev’essere cosmetica.

I cosmetici, tuttavia, possono avere talune funzioni secondarie di carattere sanitario se sono, in linea di principio, allineate alla definizione di cosmetico.

Per determinare la funzione primaria è indispensabile considerare:

- Obiettivo del produttore - Presentazione / Etichetta / Aggettivazioni pubblicitarie - Meccanismo d’azione / Composizione - Percezione da parte del consumatore.

BORDERLINE - ALCUNI ESEMPI

mary Hygienic hand soap Hand desinfectant Anti-dandruff shampoo Anti-dandruff shampoo advertised with pictures of psoriatic skin (and containing corticosteroids) medicinal product by virtue of presentation pharmacological activity & significant physiol. impact use of banned cosmetic ingredient Toothpaste with plaque control Products to detect dental plaque

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PRODOTTI BORDERLINE

3.2. Borderline with Biocides

3.2.2. "Antiseptic" or "Anti-bacterial" Mouthwash

• Question: Is a mouthwash which, according to its presentation, is “antiseptic” or “antibacterial” a cosmetic product?

• Answer: A mouthwash which presents "antibacterial" or "antiseptic" claims can be qualified as a cosmetics product, a biocidal product or as a medicinal product.

• If the product is intended to be placed in contact with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition, it may fall within the scope of application of the Cosmetics Regulation.

PRODOTTI BORDERLINE

Parametri di valutazione per la definizione di farmaco :

• Presentazione / Etichetta / Pubblicità {

Meccanismo d’azione / Composizione / Proprietà farmacologiche / modo d’uso / esposizione / sicurezza

Medicinal product by virtue of presentation

Medicinal product by virtue of function

PRODOTTI BORDERLINE

La valutazione può portare alla conclusione che il prodotto ricade all’interno dei entrambe le definizioni di farmaco e cosmetico.

In questo caso la normativa sul farmaco prevale.

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PRODOTTI BORDERLINE

3.3. Borderline with Pharmaceutical Products

3.3.3. Product containing substances which restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action

• Question: Is a product containing substances which restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action a cosmetic product?

• Answer: If a product is a medicinal product, it falls exclusively within the regulatory framework of medicinal products. A product can be a medicinal product ‘by virtue of its presentation’ or ‘by virtue of function’. The latter is the case, if the product is a substance or a combination of substances which are used in or administered to human beings inter alia with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action. However, not any minor modification of physiological function suffices to render a product a medicinal product by virtue of function.

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PRODOTTI BORDERLINE 3.3. Borderline with Pharmaceutical Products

3.3.3. Product containing substances which restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action (cont.)

• The question whether a product or its substance(s) restores, corrects or modifies physiological functions by exerting a pharmacological, immunological or metabolic action has to be taken on a case-by-case basis.

• The fact that the same substance is also contained in medicinal products as active ingredient is not decisive. However, this may be an indicator for a pharmacological, immunological or metabolic action of the substance independently of the question whether the product is ingested or used topically.

• In assessing this, one has to consider all characteristics of the product, including, for example, absorption, concentration, route of administration, frequency of application, application site, and the degree of penetration.

•

BORDERLINE - ALCUNI ESEMPI

mary Lip plumpers working by inflammation/irritation :

significant modification of one or more physiological functions Skin exfoliation vs. Skin peels

few cell layers removed : insignificant impact

stratum corneum fully removed : significant impact Product which reduces cellulite

medicinal by virtue of function because exerting a pharmacological, immunological or metabolic action.

cosmetic since not any minor modification of physiological function suffices to render a product a medicinal product by virtue of function

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PRODOTTI BORDERLINE AGGIORNAMENTO

EC Subgroup on Borderline products si è riunito il 15/04/15 e il 18/11/15 sono stati discussi alcuni possibili inserimenti:

• borderline con i giocattoli: face paints, body paints included those used via aerography,

• borderline con i farmaci: prodotti applicati attraverso tecniche invasive come i needle roller ; prodotti per modificare l’aspetto della pelle arrossata a causa di piccole dilatazioni/imperfezioni dei capillari venosi ; prodotti per il trattamento di pelle acneica (diversi stadi) ;

• borderline con i dispositivi medici: matite emostatiche .

• borderline con altre normative: strisce lubrificanti per rasoi

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PRODOTTI BORDERLINE

La Corte di Giustizia dell’UE in diversi casi ha ripetutamente stabilito che un prodotto può essere solamente o un cosmetico od un altro tipo di prodotto ma non entrambi nello stesso tempo (non-cumulation rule). Per stabilire se un prodotto debba essere considerato cosmetico o farmaco o biocida o altro occorre avere riguardo soprattutto allo scopo cui esso è destinato. La finalità, d'altra parte, non può che essere desunta dal complesso degli elementi di presentazione del prodotto valutando caso per caso in base ad una serie di parametri, in particolare la sua funzione, composizione, presentazione e percezione da parte del consumatore.

RC 1223/2009 - Articolo 20 – Claims Regolamento 655/2013- Criteri comuni

• I criteri comuni si applicano a tutti i prodotti che rientrano nella definizione di cosmetico in conformità all’Articolo 2 del Regolamento cosmetici.

• I prodotti borderline dovranno essere precedentemente valutati, utilizzando le diverse linee guida stilate dalla Commissione, prima di cercare di applicare i criteri comuni.

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Grazie della vostra attenzione

vetira@rosenet.it