the defence sector’s criteria document - chemical substances

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ARMED FORCES HEADQUARTERS Date Designation 2013-06-26 Page 1 (34) The defence sector’s criteria document - chemical substances, chemical products and articles (This document is the English translation of the Swedish original document) Content Content ............................................................................................................................ 1 1. Introduction ........................................................................................................... 2 1.1. About the criteria document ........................................................................... 2 1.2. Purpose ........................................................................................................... 2 1.3. Target group ................................................................................................... 3 1.4. Limitations ...................................................................................................... 4 1.5. Exemptions...................................................................................................... 4 1.6. Important definitions in the criteria document ............................................... 4 1.6.1. Chemical product ....................................................................................... 4 1.6.2. Article ......................................................................................................... 4 2. Requirements of the criteria document ............................................................... 5 2.1. Chemical products .......................................................................................... 5 2.2. Articles .......................................................................................................... 10 3. Exemptions for certain chemical product groups and substances .................. 12 3.1. Exemptions for certain chemical product groups ......................................... 12 3.2. Exemptions for certain substances ............................................................... 12 3.3. Application for specific exemptions .............................................................. 15 4. Examples of substances covered by the restrictions ......................................... 17 5. Examples of relevant legislation to consider ..................................................... 30 5.1. REACH (Regulation (EC) No 1907/2006) .................................................... 30 5.2. CLP (Regulation (EC) No 1272/2008) ......................................................... 31 5.3. Chemical Hazards in the Working Environment (AFS 2011:19) ................. 33 5.4. Thermosetting plastics (AFS 2005:18) ......................................................... 33 5.5. The Chemical Products (Handling, Import, and Export Prohibitions) Ordinance (SFS 1998:944) ...................................................................................... 34 5.6. RoHS 2 (EU Directive 2011/65/EU)............................................................. 34

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Page 1: The defence sector’s criteria document - chemical substances

ARMED FORCES HEADQUARTERS Date Designation

2013-06-26

Page 1 (34)

The defence sector’s criteria document - chemical

substances, chemical products and articles (This document is the English translation of the Swedish original document)

Content

Content ............................................................................................................................ 1

1. Introduction ........................................................................................................... 2

1.1. About the criteria document ........................................................................... 2

1.2. Purpose ........................................................................................................... 2

1.3. Target group ................................................................................................... 3

1.4. Limitations ...................................................................................................... 4

1.5. Exemptions ...................................................................................................... 4

1.6. Important definitions in the criteria document ............................................... 4

1.6.1. Chemical product ....................................................................................... 4

1.6.2. Article ......................................................................................................... 4

2. Requirements of the criteria document ............................................................... 5

2.1. Chemical products .......................................................................................... 5

2.2. Articles .......................................................................................................... 10

3. Exemptions for certain chemical product groups and substances .................. 12

3.1. Exemptions for certain chemical product groups ......................................... 12

3.2. Exemptions for certain substances ............................................................... 12

3.3. Application for specific exemptions .............................................................. 15

4. Examples of substances covered by the restrictions ......................................... 17

5. Examples of relevant legislation to consider ..................................................... 30

5.1. REACH (Regulation (EC) No 1907/2006) .................................................... 30

5.2. CLP (Regulation (EC) No 1272/2008) ......................................................... 31

5.3. Chemical Hazards in the Working Environment (AFS 2011:19) ................. 33

5.4. Thermosetting plastics (AFS 2005:18) ......................................................... 33

5.5. The Chemical Products (Handling, Import, and Export Prohibitions)

Ordinance (SFS 1998:944) ...................................................................................... 34

5.6. RoHS 2 (EU Directive 2011/65/EU) ............................................................. 34

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Introduction

1.1. About the criteria document

The criteria document is a tool for the defence sector to establish work

environment and environment requirements on procurement and purchasing of

chemical products and articles, and also on applicable parts of services.

The requirements in the criteria document are based on the properties of chemical

substances. All chemical products and articles delivered to the authorities of the

defence sector shall as far as possible be free from substances that are very toxic,

carcinogenic, mutagenic, toxic for reproduction, allergenic, dangerous for the

environment, climate changing and ozone depleting.

In addition to the above given properties, there are also a number of specifically

identified substances that may not be present.

The basis of the document is the EU regulations REACH ((EC) No 1907/2006)

(hereafter referred to as REACH1) and CLP ((EC) No 1272/2008) (hereafter

referred to as CLP2), and the new provisions introduced by these regulations. In

order to promote the development of chemical products and articles with less

effect on human health and the environment, the criteria document establishes

more far-reaching requirements than current chemicals legislation in many cases.

The document may also advantageously be used in the replacement of hazardous

substances (substitution) within the defence sector’s activities.

The criteria document is a governing document established by the respective

authority of the defence sector. The criteria document is administrated and

updated yearly by the defence sector’s chemical group. The group is composed of

representatives from all the authorities in the defence sector.

The latest version of the document is available from the FMV external web page

(Search path: http://www.fmv.se/en/Our-activities/Environmental-

work/Information-to-our-suppliers/The-defence-sectors-criteria-document/).

1.2. Purpose

The purpose of the criteria document is to restrict the use of substances hazardous

to human health and the environment, in chemical products and articles

(materiel), used by the authorities of the defence sector (the Swedish Armed

Forces, the Swedish Defence Material Administration, the Swedish National

1 REACH (Registration, Evaluation, Authorisation and restriction of CHemicals) is the globally

used abbreviation of Regulation (EC) No 1907/2006.

2 CLP (Classification, Labelling and Packaging) is the globally used abbreviation of Regulation

(EC) No 1272/2008.

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Defence College, the National Defence Radio Establishment, the Swedish

Defence Research Agency and the Swedish Fortifications Agency).

By restricting which chemical substances that may be present in articles and the

chemical products used in the activities, the authorities of the defence sector

contribute to the national environmental quality objective Non-toxic environment,

adopted by the Swedish Parliament. The Swedish Chemicals Agency is the

agency responsible for following up, coordinating and evaluating how this object

is achieved. The work can be followed at www.kemi.se.

1.3. Target group

The defence sector’s suppliers are the main target group for the criteria document.

Employees within the defence sector are also a target group, as the criteria

document advantageously may be used in the authorities environmental

management work.

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1.4. Limitations

The following product groups are not covered by the criteria document:

Pesticides, chemical weapons according to the Chemical Weapons Convention,

radioactive substances and medicinal products.

The limitations are justified by that these product groups are covered by specific

legislation and that the content of hazardous substances is essential for the

function of the products.

1.5. Exemptions

Exemptions from the requirements in the criteria document are granted by the

authorities of the defence sector when it is not currently considered to be

technical possible or economical feasible to avoid certain chemical products or

certain chemical substances in articles. Exemptions are described in section 3.

1.6. Important definitions in the criteria document

1.6.1. Chemical product

A chemical product3 is defined as a substance or a mixture of two or more

substances. Acetone and urea are examples of chemical products that are

substances. Chemical products that are mixtures are for example paints and fuels.

A substance4 is defined as a chemical element and its compound

5, including any

additives necessary to preserve its stability and any impurity deriving from the

manufacturing process used, but excluding any solvent which may be separated

without affecting the stability of the substance or changing its composition.

A mixture is defined as a mixture or solution composed of two or more

substances.

1.6.2. Article

An article is defined as an object which during production is given a special

shape, surface or design which determines its function to a greater degree than

does it chemical composition. Examples of articles in the defence sector are

different materiel such as vehicles, tents, desks, computers and pieces of uniforms

etc.

3 The definition of a chemical product is found in §1 in KIFS 2005:7

4 The definition of a substance, mixture and article is found in chapter 2 article 3 in REACH

5 For practical reasons, certain mixtures of closely related molecules are regarded as a substance,

for example naphtha.

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2. Requirements of the criteria document

The following section is divided into requirements for chemical products and for

articles.

It is important to note that compliance with the criteria document does not exclude the

supplier´s obligation to have sufficient competence about and responsibility for

substances in its chemical products or articles.

The supplier is responsible to comply with both Swedish legislation and regulations and

other laws decided by the EU, which the chemical product or article is subject to.

2.1. Chemical products

The flow chart below shows how the criteria document shall apply to chemical

products and how to decide whether a chemical product can or can’t be accepted.

The chemical

product is a

substance

No

Yes

Substitute!

No

Is the mixture covered

by the restrictions in

tables 1 and/or 3?

The chemical

product can be

accepted

The chemical

product can not be

accepted

The chemical

product is a

mixture

Yes

Yes

No

Is the substance covered

by the restrictions in

tables 2 and/or 3?

Do alternatives not covered

by a restriction exist?

Are exemptions allowed

under Section 3.1 or 3.2?

YesAre exemptions allowed

if there is exceptional reasons

See section 3.3

No

Section 4: Examples of

substances that are covered

by the restrictions in tables

3 and 4.

Note that substitution

always shall be

considered before

exemptions are used.

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Table 1 and 2 shows the classifications that shall be avoided for chemical

products.

Chemical products which have been classified according to table 1 or 2 may

cause serious health and environmental effects, even by single or short-term use.

Table 3 shows additional restrictions on chemical products, regarding

substances. These substances do not fall for the criteria according to table 2, but

are nevertheless important to restrict because of their health and environmentally

hazardous properties.

The criteria document has taken into account that there, during a time-period,

will be two parallel classification and labelling systems (KIFS6 2005:7 and

CLP) for chemical products, by giving different criteria for chemical products

defined as mixtures and substances respectively:

Table 1 shall be used for chemical products defined as mixtures.

Table 2 shall be used for chemical products defined as substances.

6 KIFS is the provisions of the Swedish Chemicals Agency, introducing inter alia the Dangerous

Substances Directive, DSD, (67/548/EEC) and the Dangerous Preparations Directive, DPD,

(1999/45/EEC) in Swedish legislation.

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Table 1. Chemical products, defined as mixtures, shall be avoided if they are

classified (according to KIFS 2005:7) with the risk phrases given below:

Risk phrase Danger symbol Indication of danger

R 26 Very toxic by inhalation

Very toxic

R 27 Very toxic in contact with skin

R 28 Very toxic if swallowed

R 39 Danger of very serious irreversible effects.

(In combination with R 26, R27 and/or R 28)

R 42 May cause sensitisation by inhalation

Harmful

R 43 May cause sensitisation by skin contact

Irritant

R 45 May cause cancer (Carc. Cat 1/ Carc. Cat 2)

-

R 46 May cause heritable genetic damage

-

R 49 May cause cancer by inhalation (Carc. Cat

1/ Carc. Cat 2)

-

R 50/53 Very toxic to aquatic organisms, may

cause long-term adverse effects in the aquatic

environment

Dangerous for the

environment

R 59 Dangerous for the ozone layer

Dangerous for the

environment

R 60 May impair fertility

(Repr. Cat 1/ Repr. Cat 2)

-

R 61 May cause harm to the unborn child

(Repr. Cat 1/ Repr. Cat 2)

-

R 64 May cause harm to breastfed babies - -

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Table 2. Chemical substances, defined as substances, shall be avoided if they are

classified (according to CLP) with the hazard statements given below:

Hazard statement Hazard pictogram Signal word

H300 Fatal if swallowed (hazard category 1 and 2)

Danger

H310 Fatal in contact with skin (hazard category 1

and 2)

Danger

H317 May cause an allergic skin reaction (hazard

category 1 and sub category 1A and 1B)

Warning

H330 Fatal if inhaled (hazard category 1 and 2)

Danger

H334 May cause allergy or asthma symptoms or

breathing difficulties if inhaled (hazard category 1 and

sub category 1A and 1B)

Danger

H340 May cause genetic defects

(hazard category 1A and 1B)

Danger

H350 May cause cancer (hazard category 1A and 1B)

Danger

H350i May cause cancer by inhalation (hazard

category 1A and 1B)

Danger

H360FD May damage fertility. May damage the

unborn child (hazard category 1A and 1B)

Danger

H360F May damage fertility (hazard category 1A and

1B)

Danger

H360D May damage the unborn child (hazard

category 1A and 1B)

Danger

H362 May cause harm to breast-fed children - -

H370 Causes damage to organs (hazard category 1)

Danger

H410 Very toxic to aquatic life with long lasting

effects (hazard category: Chronic 1)

Warning

H420 Harms public health and the environment by

destroying ozone in the upper atmosphere (hazard

category 1)

Warning

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Table 3. Additional restrictions on chemical products.

Substances with PBT-properties7 shall not be present in concentrations ≥0.1%

Substances with vPvB-properties8 shall not be present in concentrations ≥0.1%

Substances on the Candidate list9 shall not have been intentionally added

10

Substances with a GWP-factor11

above 2000 (calculated over 100 years) shall

not have been intentionally added

Substances specifically identified by the defence sector12

- shall not have been

intentionally added

Gamma-butyrolactone (GBL)

Gamma-hydroxybutyrate (GHB)

Methylene chloride

Nonylphenol ethoxylate

7 PBT = Persistent (low degradability), bioaccumulative (potential to accumulate in living

organisms) och toxic (poisonous). vPvB = Very persistent and very bioaccumulative. Substances

with PBT- and vPvB-properties are defined through criteria in Annex XIII to the REACH

regulation. Examples on PBT- and vPvB-substances:

http://esis.jrc.ec.europa.eu/index.php?PGM=pbt 8 See foot-note immediately above.

9 The latest version of the Candidate list: http://echa.europa.eu/sv/candidate-list-table

10 Not intentionally added means that substances shall not have been intentionally added to the

raw material or product during any stage of the manufacturing process. 11

The GWP-factor för a substance is its Global Warming Potential. See GWP-values according to

the latest IPCC-report or equivalent, or ”Listing of GWP-values” (FMV document designation

12FMV 1533-1:1)

http://www.fmv.se/Global/Dokument/Engelska%20webben/Our%20activities/Enviromental%20w

ork/Environmental%20criteria%20documents/121023/12FMV1533%202%201%20GWP%20eng.

pdf 12

Substances not covered by the criteria in table 3 or 4 and groups of substances where not all the

substances are covered by the criteria in table 4 but that, because of other hazardous properties or

regulatory restrictions, are not wanted in the defence sector. See section 4 in the criteria document

for the CAS No of the substance and the justification for pointing out the substance as not wanted.

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2.2. Articles

The flow chart below shows how the criteria document shall apply to articles and

how to decide whether an article can or can’t be accepted.

Yes No

Yes

The article can be

accepted

The article can not

be accepted

Substitute!

Yes

No

No

Article

Section 4: Examples of

substances that are covered

by the restrictions in tables

3 and 4.

Do alternatives not covered

by the restriction exist?

Is the Article covered

by the restrictions in

Table 4?

Are exemptions allowed

under Section 3.1 or 3.2?

Yes

Are exemptions allowed

if there is exceptional

reasons

See section 3.3

No

Table 4 shows additional restrictions on substances/groups of substances in

articles, based on properties that may cause serious health and environmental

effects.

Note that the concentration limit of 0.1 % shall be calculated according to the

Swedish interpretation of the information provision in REACH. See more

information in section 5.

Note that substitution

always shall be

considered before

exemptions are used.

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Table 4. Restrictions of substances/groups of substances in articles.13

Substances with CMR-properties14

in category 1 or 2 according to directive

67/548/EEG or category 1A or 1B in the CLP regulation ((EC) Regulation No

1272/2008) shall not be present > 0.1%

Substances with PBT-properties15

shall not be present > 0.1%

Substances with vPvB-properties16

shall not be present > 0.1%

Substances on the Candidate list17

shall not be present > 0.1%

Substances with a GWP-factor18

above 2000 (calculated over 100 years) shall

not have been intentionally added19

Ozone-depleting substances20

shall not have been intentionally added

Substances specifically identified by the defence sector 21

- shall not have been

intentionally added

Lead and its compounds/salts

Decabromodiphenylether (Deca-BDE)

Cadmium and its compounds/salts

Mercury and its compounds/salts

Nonylphenol ethoxylate

Pentabromodiphenylether (Penta-BDE)

13

In cases where EU legislation specifies a lower restriction limit than 0.1 % in the article (or

prohibits the use), the legislative restriction shall apply. 14

CMR = Carcinogenic, mutagenic (may cause heritable genetic defects) and/or toxic to

reproduction (may impair fertility or harm the embryo/foetus). Examples of such substances can

be found in the Classification list Annex VI, table 3.1 and 3.2 in CLP (EC) No 1272/2008, which

contains harmonised and binding classification and labelling for substances and groups of

substances. 15

PBT = Persistent (low degradability), bioaccumulative (potential to accumulate in living

organisms) and toxic (poisonous). vPvB = Very persistent and very bioaccumulative. Substances

with PBT- and vPvB-properties are defined through criteria in Annex XIII to the REACH

regulation. Examples on PBT- and vPvB-substances:

http://esis.jrc.ec.europa.eu/index.php?PGM=pbt 16

See foot-note immediately above. 17

The latest version of the Candidate list: http://echa.europa.eu/sv/candidate-list-table 18

The GWP-factor for a substance is its Global Warming Potential. See GWP-values according to

the latest IPCC-report or equivalent, or ”Listing of GWP-values” (FMV document designation

12FMV 1533-1:1)

http://www.fmv.se/Global/Dokument/Engelska%20webben/Our%20activities/Enviromental%20w

ork/Environmental%20criteria%20documents/121023/12FMV1533%202%201%20GWP%20eng.

pdf 19

Not intentionally added means that substances shall not have been intentionally added to the

raw material or product during any stage of the manufacturing process 20

Substances that may present a danger to the structure or functioning of the stratospheric ozone

layer, i.e. fulfils classification criteria R59 (under KIFS 2005:7) or H420 (under CLP). 21

Substances not covered by the criteria in table 3 or 4 and groups of substances where not all the

substances are covered by the criteria in table 4 but that, because of other hazardous properties or

regulatory restrictions, are not wanted in the defence sector. See section 4 in the criteria document

for the CAS No of the substance and the justification for pointing out the substance as not wanted.

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Polybrominated biphenyls (PBBs)

3. Exemptions for certain chemical product groups and substances

Exemptions accepted by the authorities of the defence sector are specified in table

5 and 6. Note that substitution always shall be considered before exemptions are

used. If the exemption is specified in table 5 and 6, the supplier does not need to

apply for exemption according to 3.3.

3.1. Exemptions for certain chemical product groups

Table 5: Exemptions accepted for certain product groups.

Chemical products Exemptions for use as Grounds for exemption

Zinc phosphate and high zinc

content primers classified as

R50/53

Replacement for

chromates in primers.

The risk for the environment

will be lower than when using

chromates.

Thermosetting plastics with

thermosetting plastic components

(according to the definition in

AFS 2005:18 section 5) classified

as R42 and/or R43* and also

polysulfides classified as R42

and/or R43*.

Foam sealant, moulding

component, sealant,

primer, paint, lacquer and

adhesives.

The use is regulated by The

Swedish Work Environment

Authority’s statute book

2005:18 “Thermosetting

Plastics” (AFS 2005:18). The

health risks when using

thermosetting plastics are

small if the provisions are

complied with.

Products in the Swedish Armed

Forces’ Product catalogue –

Fuels, lubricant and associated

products (CD PRKAT Drivmedel

M7789-000183 Swedish edition

alternatively M7789-000193

English edition).**

Fuels (i.e. lubricants, brake

fluids, antifreeze agents) in

the materiel system

(vehicles, ships, aircrafts

etc.) of the Swedish

Armed Forces and the

Swedish Defence Material

Administration.

The products in the catalogue

are evaluated and the

management is made clear.

New products in the Product

catalogue shall be evaluated

according to section 2. A

limited assortment reduces

the environment impact.

* exemptions are not permitted for other criteria in table 1 and table 2.

** www.fmv.se/en/Our-activities/Fuels-lubricant-and-associated-products/

3.2. Exemptions for certain substances

Tabl 6: Exemptions accepted for certain substances in chemical products or in

articles.

Name of the substance CAS No Exemptions for use

Anthracene 120-12-7 - Signal smoke

Arsenic and its compunds 7440-38-2

Several

- Doped semi-conductors in electronics

- Alloys in pipe couplings

Diarsenic pentaoxide and diarsenic trioxide are

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Name of the substance CAS No Exemptions for use

listed in Annex XIV in the REACH regulation.

Sunset date for use/placing on the market without

authorisation: 21 August 2015.

Beryllium (metal) 7440-41-7 - Beryllium in copper alloys

Beryllium oxide 1304-56-9 - Electrical components which are

encapsulated and specifically marked

Lead (metal) 7439-92-1 - Diving weights

- Ballast

- Small calibre ammunition incl. small

pellets

- Radiation protection materiel

- Max 0.1percent by weight in homogenous

material in electrical and electronic

equipment within the scope of the RoHS

directive22

- Electrical and electronic equipment that is

not within the scope of the RoHS directive

- Batteries where lead-free alternatives are

lacking

- Electrolytic cells

Lead-azide, -fulminate, -

picrate, -styphnate etc.

Several - Ignition in detonators etc., where

alternatives are lacking. Note that if these

substances are included in ignition in

detonators etc. information shall be

provided regardless of the level of content.

Lead oxides Several - Propellant in medium calibre ammunition

(>20 mm)

- Additive in rocket engine propellants

- Ignition caps

- Max 0.1percent by weight in homogenous

material in electrical and electronic

equipment within the scope of the RoHS

directive

- Electrical and electronic equipment that is

not within the scope of the RoHS directive

Boric acid 10043-35-3 /

11113-50-1

- Electrolytic cells

Dibutyl phthalate (DBP) 84-74-2 - Stabiliser in gun powder

The substance is listed in Annex XIV in the

REACH regulation. Sunset date for use/placing

on the market without authorisation: 21 February

2015.

22 RoHS 2 (Restriction of Hazardous Substances in Electrical and Electronic Equipment) is the

globally used abbreviation of Directive 2011/65/EU.

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Name of the substance CAS No Exemptions for use

2,4-Dinitrotoluene 121-14-2 - As component in explosives.

The substance is listed in Annex XIV in the

REACH regulation. Sunset date for use/placing

on the market without authorisation: 21 August

2015.

Halons Several Commission Regulation (EU) No 744/2010

applies for halons. Exemptions apply for use

of halons that can’t be replaced by another

substance or new technology. (Note that

legislation always shall be complied with)

HCFC Several - Replenishment of existing refrigeration

systems, to and including 2014 according

to SFS 2007:846

1,1,1,3,3,3-Hexafluoro-

propan (HFC 236fa,

DeugenN)

920-66-1 - Fire extinguishing equipment in combat

vehicles

Cadmium and its

compounds

7440-43-9

Several

- Max 0.01percent by weight in homogenous

material in electrical and electronic

equipment within the scope of the RoHS

directive

- Electrical and electronic equipment that is

not within the scope of the RoHS directive

- Use in systems critical to safety and in

applications/components critical to function

- Batteries where alternatives to

nickel/cadmium are lacking

Potassium perchlorate 7778-74-7 - Pyrotechnics

Chromium (VI) compounds Several - Max 0.1percent by weight in homogenous

material in electrical and electronic

equipment within the scope of the RoHS

directive

- Electrical and electronic equipment that is

not within the scope of the RoHS directive

- Paint system according to defence standard

FSD

- Sealant and surface layer on aluminium and

magnesium. Applies to and including 2014

Mercury (metal) 7439-97-6 - Max 0.1percent by weight in homogenous

material in electrical and electronic

equipment within the scope of the RoHS

directive

- Electrical and electronic equipment that is

not within the scope of the RoHS directive

- Sources of light

- Button cell batteries

Polybrominated biphenyls

(PBB)

Several - Max 0.1percent by weight in homogenous

material in electrical and electronic

equipment within the scope of the RoHS

directive

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Name of the substance CAS No Exemptions for use

- Electrical and electronic equipment that is

not within the scope of the RoHS directive

Polybrominated diphenyl

ethers (PBDE)

Several - Max 0.1percent by weight in homogenous

material in electrical and electronic

equipment within the scope of the RoHS

directive

- Electrical and electronic equipment that is

not within the scope of the RoHS directive

The following polybrominated diphenyl ethers

are prohibited in the EU by Regulation (EC) No

850/2004 on persistant organics pollutants

(POP):

- Tetrabromodiphenylether

- Pentabromodiphenylether

- Hexabromodiphenylether

- Heptabromodiphenylether

Note that exemptions for use only apply when

the specific use is exempted in the legislation.

Sulfur hexafluoride 2551-62-4 - Gas insulated medium-voltage switchgear

and control instruments in power

distribution grids (≤52 kV)

3.3. Application for specific exemptions

If the exemption is not specified in table 5 or 6, the supplier may apply for

exemption for the use of a specific chemical product, or for a substance contained

in an article or a chemical product, provided that there are exceptional reasons

and that an acceptable substitute is not available. Examples of exceptional reasons

are that the substance is needed to achieve a critical function or that the nature of

the work requires the use of this substance. A prerequisite to apply for

exemptions is that there is no hindrance from the legislation in force, as

restrictions or bans on the use of the substance. In an application for exemption,

the handling shall be well justified and risks assessed by the supplier.

Regarding substances of very high concern that are included in the Candidate

list23

or in Annex XIV in REACH24

and that are intentionally added to a chemical

product or an article, the supplier shall in the application for exemption also

include which actions, such as substitution of the hazardous substance or

application for authorisation, that will be taken in order to ensure continued

delivery of the chemical product or article.

23

http://echa.europa.eu/sv/candidate-list-table 24

See section 5.1 for more information about the Candidate list and REACH

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Application for exemption is sent to each relevant authority within the

defence sector. Each authority has its own guidelines on the administration

of the application. An application for exemption that is refused by the concerned

authority implicates that the chemical substance/product is not allowed to be used

in the specific case.

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4. Examples of substances covered by the restrictions

Table 7 contains examples of substances not accepted according to the criteria in

section 2 and the reasons for this are given. Examples of uses within the defence

sector are also given in the table.

Exemptions from these restrictions have been granted for ceratin applications in

the defence sector. If such exemptions exist, they are given in the far right-hand

column, and these are then shown in section 3.

Note that this is not an exhaustive list. The table is intended as a guidance and

only includes examples of substances relevant for the defence sector.

Suppliers thus have the full responsibility to ensure that substances in their

chemical products and articles are not covered by the restrictions in section 2.

Classifications given in the table are harmonised within the EU and are given in

Annex VI in CLP. In cases where the substance has no harmonised

classification the box is left blank. Note that all classifications of the substances

are not given, only those declaring why the substance is restricted in relation to

the criteria given in section 2.

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Table 7. Examples of substances covered by the restrictions in section 2.

Legend to the table

Marking Refers to:

* Candidate list

** Annex XIV (REACH) - Substances subject to application

*** Substances specifically identified by the defence sector

Substance/

group of

substances

CAS No

Reasons for

avoiding the

substance Examples of use

Exemptions for

certain

applications CLP

KIFS

2005:7

Acrylamide

79-06-01 Carc.1B:

H350

Mut.1B;

H340

H317

Carc.

Cat.2;

R45

Mut.Cat.

2;R46

Raw-material for synthesis of

plastic and flocculation agent

for water purification. Present

in sealants in the building

industry

*

Alkanes, C10-13,

chloro (Short Chain

Chlorinated

Paraffins)

85535-84-8 Aquatic

Chronic 1;

H410

N; R50-53 Flame retardant and plasticiser

in the plastic and rubber

industry. (Regulated in both

REACH and EC No 850/2004)

*(PBT-substance)

Aluminium silicate

Refractory ceramic

fibre

Several Carc.1B;

H350i

Carc.

Cat.2;

R49

Fire protection for industrial

equipment, i.e. within the

aircraft and vehicle industry.

Insulating material in kilns.

*

Amosite (Asbestos

material)

12172-73-5 Carc.1A;

H350

Carc.

Cat.1;R45

Insulation for pipes, fireproof

insulation boards, sprayed

asbestos.

Antophyllite

(Asbestos material)

77536-67-5 Carc.1A;

H350

Carc.

Cat.1;R45

Insulation materials, adhesives,

plastic, filling and

reinforcement material.

Anthracene 120-12-7 Signal smoke Yes (see table 6)

*(PBT/vPvB-

substance) H410

Arsenic and its

compounds

- Diarsenic

pentaoxide

- Diarsenic trioxide

Several

1303-28-2

1327-53-3

Carc.1A;

H350

Carc.Cat

1; R45

Electronics, surface treatment,

pressuretreated (preserved)

wood.

Arsenic is used in certain

alloys. Among other things in

ammunition.

Yes (see table 6)

*

**

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Substance/

group of

substances

CAS No

Reasons for

avoiding the

substance Examples of use

Exemptions for

certain

applications CLP

KIFS

2005:7

Asbestos

- Amosite

- Antophyllite

- Crokidolite

- Chrysotile

12172-73-5

77536-67-5

12001-28-4

12001-29-5

Carc.1A;

H350

Carc.

Cat.1;

R45

Brake linings, building

material, thermal insulation

Benzene 71-43-2 Carc.1A;

H350

Muta 1B;

H340

Carc.

Cat.1;

R45

Solvent, in petrol.

Benzyl butyl

phthalate (BBP)

85-68-7 Repr.1B;

H360Df

H410

Repr.Cat2;

R61

Plasticiser

*

**

Beryllium and its

compounds

Several Carc. 1B;

H350i

Carc.Cat2;

R49

Electronics, radar Yes (see table 6)

Bis (tributyl tin)

oxide (TBTO)

56-35-9

Occurs as preservative in

imported articles such as

textile, paper, leather, rubber

and polymeric materials.

*(PBT-substance)

Lead and its

compounds. See

examples below

Several Lead may release

soluble lead salts.

Major parts of lead

compounds are toxic

for reproduction and

some are also

carcinogenic, many are

classified.

Batteries, electrical and

electronic products,

ammunition, weights, surface

treatment, transport fuels and

lubricants (lubricants, fuel,

oils) etc.

Yes (see table 6)

***

Lead azid 13424-46-9 Repr.1A;

H360Df

H410

Repr.Cat;

R61

For ignition and reinforcement

in detonators for civil and

military use.

Yes (see table 6)

*

Lead chromate 7758-97-6 Carc.1B;

H350

Repr 1A;

H360Df

H410

Carc.

Cat.2;

R45,

Repr.

Cat.1;

R61

Pigment in paint, especially for

rustprotection, e.g. for

vehicles, aircraft, agricultural

machinery and road signs.

Also military when marking

camouflage and ammunition.

*

**

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Substance/

group of

substances

CAS No

Reasons for

avoiding the

substance Examples of use

Exemptions for

certain

applications CLP

KIFS

2005:7

Lead chromate

molybdate sulphate

(C.I.Pigment Red

104)

12656-85-8 Carc.1B;

H350

Repr 1A;

H360Df

H410

Carc.

Cat.2;

R45,

Repr.

Cat.1;

R61

Pigment in paint, especially for

rust protection, e.g. for

vehicles, aircraft, agricultural

machinery and road signs.

Also military when marking

camouflage and ammunition.

*

**

Lead chromate

Sulphate

(C.I.Pigment

Yellow 34)

1344-37-2 Carc.1B;

H350,

Repr. 1A;

H360Df

H410

Carc.

Cat.2;

R45,

Repr.

Cat.1;

R61

Pigment in paint, especially for

rustprotection, e.g. for

vehicles, aircraft, agricultural

machinery and road signs.

Also military when marking

camouflage and ammunition.

*

**

Lead (II) picrate 6477-64-1 Repr. 1A;

H360Df

Repr.

Cat.1;

R61

May occur in low levels in

detonators, along with lead

azide and lead styphnate.

Yes (see table 6)

*

Lead styphnate 15245-44-0 Repr. 1A;

H360Df

H410

Repr.

Cat.1;

R61

For ignition in small

calibre ammuntion.

Yes (see table 6)

*

Boron sodium

oxide hydrate

12267-73-1 Repr. 1B;

H360DF

Repr.

Cat.2;

R60-61

Used as wood preservative,

flame retardant etc.

*

Boric acid 10043-35-3

11113-50-1

Repr. 1B;

H360FD

Repr.

Cat. 2:

R60-61

Raw-material for glass and

ceramics. Agent for wood

protection, fertilisation, dis-

infection, flame protection,

metal treatment. In photo

chemicals and in adhesives.

May be found in preserved

timber and in flame-retarded

insulation materials.

Yes (see table 6)

*

Di(branched C6-

C8)alkyl phthalates

71888-89-6 Repr.1B;

H360D

Repr.

Cat.2;R61

Plasticiser in PVC plastics.

*

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Substance/

group of

substances

CAS No

Reasons for

avoiding the

substance Examples of use

Exemptions for

certain

applications CLP

KIFS

2005:7

Di(branched and

linear C7-C11)

alkyl phthalates

68515-42-4 Repr.1B;

H360Df

Repr.

Cat 2;

R61

Plasticiser in plastics.

*

Brominated

flameretardants

(some):

-Decabromo

diphenyl ether

(Deca-BDE)

-Hexabromo

cyclododecane

(HBCDD)

(stereoisomers)

- Octabromo

diphenyl ether

(Octa-BDE)

- Pentabromo

diphenyl ether

(Penta-BDE)

- Polybrominated

biphenyls (PBB)

such as 2,3,3´,4,4´,

5´-Hexabromo

biphenyl

Several

1163-19-5

25637-99-4

3194-55-6

(134237-

50-6,

134237-51-

7, 134237-

52-8)

32536-52-0

32534-81-9

Several

59536–65–

1

Different properties,

e.g. toxic for

reproduction, PBT.

See respective

substance.

Flame retardant Yes (see table 6) Applies in certain

cases within the

substance groups

PBB and PBDE.

CFC

Several Refrigerant, also propellants.

Ozone depleting

potential

GWP>2000

Decabromo

diphenyl ether

(Deca-BDE)

(The substance is a

PBDE)

1163-19-5 Flame retardant Yes (see table 6)

*

*** (Suspected to

damage the

development of the

brain)

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Substance/

group of

substances

CAS No

Reasons for

avoiding the

substance Examples of use

Exemptions for

certain

applications CLP

KIFS

2005:7

4,4'-Diaminodi-

phenylmethane,

MDA

101-77-9 Carc.1B;

H350

STOT SE

1; H370

Skin Sens.

1; H317

Carc.

Cat.2;

R45

T;

R39/23/24

/25

Xi; R43

Used in the production of

Methylene Diphenyl

Diisocyanate and certain

polymers.

Curing agent for plastic

and adhesives.

*

**

Di(2-ethylhexyl)

phthalate (DEHP)

117-81-7 Repr.1B;

H360FD

Repr.

Cat.2;

R60-61

Plasticiser

*

**

Di(2-methoxyethyl)

phthalate

117-82-8 Repr.1B;

H360Df

Repr.

Cat.2;

R61

Plasticiser

*

Diarsenic

pentaoxide

1303-28-2 Carc. 1A;

H350

H410

Carc.

Cat. 1;

R45

Wood protection, special glass

*

**

Diarsenic trioxide 1327-53-3 Carc. 1A;

H350

H410

Carc.

Cat. 1;

R45

Wood protection, special glass,

enamel

*

**

Dibutyl phthalate

(DBP)

84-74-2 Repr.1B;

H360Df

Repr.

Cat.2;R61

Plasticiser

*

**

Diisobutyl phthalate 84-69-5 Repr.1B;

H360Df

Repr.

Cat 2;

R61

Plasticiser

*

**

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Substance/

group of

substances

CAS No

Reasons for

avoiding the

substance Examples of use

Exemptions for

certain

applications CLP

KIFS

2005:7

2,4-Dinitrotoluene 121-14-2 Carc.1B:

H350;

Aquatic

Chronic 1;

H410

Carc. Cat.

2; R45

N; R50-53

Included as a component

in explosives. Used to make

the product mouldable and to

modify the burn rate of gun

powder. 2,4-Dinitrotoluene is

left as non separable residue

(contamination) in TNT.

Yes (see table 6)

*

**

2-Ethoxyethanol 110-80-5 Repr.1B;

H360FD

Repr.

Cat.2;

R60-61

Solvent

*

2-Ethoxyethyl-

acetate

111-15-9 Repr.1B;

H360FD

Repr.

Cat.2;

R60-61

Solvent

*

Ethylene glycol

monomethyl ether

(2-Methoxyethanol)

109-86-4 Repr.1B;

H360FD

Repr.

Cat.2;

R60-61

Solvent

*

Fluorohydro-

carbons (HFC) some

HFC–23

HFC–125

HFC–143a

HFC–227ea

HFC–236fa

Several

75-46-7

354-33-6

420-46-2

431-89-0

690-39-1

Propellants

The example

substances given have

GWP >2000

Formaldehyde,

oligomeric reaction

products with

aniline (Technical

grade MDA, UVCB

25214-70-4

(101-77-9)

Carc.1B;

H350

(CAS nr:

101-77-9)

Carc.

Cat.2;

R45

(CAS nr:

101-77-9)

Used as curing agent in epoxy

resins, e.g. in adhesives, paints

and lacquer. May be present

in pipe couplings and moulds.

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Substance/

group of

substances

CAS No

Reasons for

avoiding the

substance Examples of use

Exemptions for

certain

applications CLP

KIFS

2005:7

substance that

mainly consists of

4,4’-diamino

diphenyl methane,

CAS No:101-77-9

(see above). The

classification of the

substance is based

on the content of

4,4’-diamino

diphenyl methane)

*

**

Phthalates, some

Benzyl butyl

phthalate (BBP)

Di(2-ethylhexyl)

phthalate (DEHP)

Dibutyl phthalate

(DBP)

Diisobutylphthalate

Di(2-ethoxyethyl)

phthalate

Several

85-68-7

117-81-7

84-74-2

84-69-5

117-82-8

The phthalates given

are classified as toxic

for reproduction, and

listed in Annex XIV

and/or the Candidate

list, se respective

substance.

Plasticiser in polymer

products. Present in paints, raw

material for plastics, rubber,

adhesives, fillers and in raw

material for paints

Gamma-

butyrolactone

(GBL)

96-48-0 Solvent

***(Classified as

narcotic)

Gamma-

hydroxybutyrate

(GHB)

591-81-1 Solvent

***(Classified as

narcotic)

Halons

e.g. halon-1211,

halon- 1301

Several Fire estinguishing agents Yes (see table 6)

Ozone depleting

potential GWP > 2000

HA-oils (High

aromatic oils).

Contains 10 - 30 %

polyaromatic

hydrocarbons, PAH

- Tyres

Contains high levels of

substances (e.g.

benzo[a]pyrene,

anthracene) classified

as inter alia Carc. 1B

and PBT.

HCFC Several Refrigerant, propellants. Yes (see table 6)

GWP> 2000

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Substance/

group of

substances

CAS No

Reasons for

avoiding the

substance Examples of use

Exemptions for

certain

applications CLP

KIFS

2005:7

Hexabromo

cyclododecane

(HBCDD)

(stereoisomers)

25637-99-

4,

3194-55-6

(134237-

50-

6,134237-

51-7,

134237-52-

8)

Flame retardant

*(PBT)

**

1,1,1,3,3,3-

Hexafluoro-propane

(HFC 236fa,

DeugenN)

920-66-1 Fire extinguishing agent,

refrigerant

Yes (see table 6)

GWP>2000

Cadmium and its

compounds

Several Cadmium may release

soluble compounds.

Many are classified as

carcinogenic and

toxic for reproduction.

Electrical and electronic

products, batteries, metals and

alloys, surface treatment,

paints and lacquers.

Yes (see table 6)

***

Ceramic fibres

See: Aluminium

silicate

Refractory ceramic

fibre

Refers to

fibres

covered by

index

number:

650-017-

00-8 and

that in

addition

fulfills

certain

conditions,

see

Candidate

list

Insulating material for

industrial use in high

temperature applications.

Fire protection for industrial

equipment, i.e. within the

aircraft and vehicle industry.

* (Carc. 1B / Carc.

Cat 2)

Cobalt salts such

as

- Cobalt dichloride

Several

7646-79-9

Carc.1B;

H350i

Repr.1B;

H360F

Aquatic

Chronic 1;

H410

Carc.

Cat.2;

R49

Repr.

Cat.2;

R60

N; R50-53

Humidity indicator in silica gel

*

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Substance/

group of

substances

CAS No

Reasons for

avoiding the

substance Examples of use

Exemptions for

certain

applications CLP

KIFS

2005:7

Carbon tetra

chloride

56-23-5 Ozone;

H420

N;R59 Solvent

Creosote 8001-58-9 Carc. 1B;

H350

Carc.

Cat2;R45

In pressure-treated (preserved)

wood

Crokidolite

(Asbestos material)

12001-28-4 Carc. 1A;

H350

Carc. Cat

1; R45

Products of concrete with

asbestos, filters, gaskets,

insulation.

Chromium (VI)

compounds

- Potassium

dichromate

-Chromium trioxide

(Chromium (VI)

oxide)

- Sodium

dichromate

- Sodium

dichromate

dihydrate

Several

7778-50-9

1333-82-0

10588-01-9

7789-12-0

Carc. 1B;

H350 (all)

Muta. 1B;

H340

(some)

Repr. 1B;

H360FD

(some)

Aquatic

Chronic 1;

H410

Carc. Cat

2: R45

(all) Muta.

Cat 2:

R46

(some)

Repr. Cat

2: R61,

R62

(some)

N; R50-53

Rust protection agents,

electrical products, pressure-

treated (preserved) wood

Yes (see table 6)

*

Chrysotile

(Asbestos material)

12001-29-5 Carc. 1A;

H350

Carc. Cat

1; R45

Concrete with asbestos,

fireproof insulating boards,

gaskets, sealants, friction

linings, adhesives, joint seams,

textile products, carpets,

paints.

Mercury and its

compounds

Several Mercury and its

compounds are

classified as inter alia

dangerous for the

environment, toxic and

toxic for reproduction.

Adverse effects from

exposure can above all

be seen on the

development and

function of the nervous

system, on the

cardiovascular system,

the immune system,

the reproductive

system and the

kidneys.

Electrical products, batteries,

alloys

Yes (see table 6)

***

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Substance/

group of

substances

CAS No

Reasons for

avoiding the

substance Examples of use

Exemptions for

certain

applications CLP

KIFS

2005:7

1-Methyl-2-

pyrrolidone

(NMP)

872-50-4 Repr. 1B;

H360D

Repr. Cat.

2; R61

Solvent in paints, lacquers and

detergents, car care products,

degreasers, paint removal, anti-

friction lacquers.

*

Methylene chloride

(dichloromethane)

75-09-2 Solvent

*** (prohibited to use

the substance

occupationally in

Sweden (SFS

1998:944). Also

restrictions within the

rest of the EU

(REACH Annex

XVII), limited

evidence of a

carcinogenic effect

(Carc. Cat 3))

Sodium borates

Disodium

tetraborate

Disodium

tetraborate

pentahydrate

Disodium

tetraborate

decahydrate

Tetraboron

disodium

heptaoxide, hydrate

Several

1330-43-4

12179-04-3

1303-96-4

12267-73-1

Repr. 1B;

H360FD

Repr. Cat

2; R60,

R61.

Raw material for glass and

ceramics. Agent for wood

protection, fertilisation,

disinfection, flame protection,

cleaning, metal treatment.

Photo chemical, in adhesives.

In preserved timber and in

flame retarded insulation

materials.

*

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Substance/

group of

substances

CAS No

Reasons for

avoiding the

substance Examples of use

Exemptions for

certain

applications CLP

KIFS

2005:7

Sodium dichromate

Sodium dichromate,

dihydrate

10588-01-9

7789-12-0

Carc. 1B;

H350

Muta. 1B;

H340

Repr. 1B;

H360FD

AcuteTox.

2; H330,

Resp

Sens.1;

H314

Skin

Sens.1;

H314

Carc. Cat.

2; R45

Muta.Cat.

2; R46

Repr.Cat.

2; R60-61

T+; R26

Xn;

R42/43

In surface treatment agents for

metals and galvano-technical

products.

Yes (see table 6)

*

Nonylphenol

etoxylate

((C2 H4 O)n

C15H24O)

9016-45-9 Surface active substance that is

above all used in detergents,

but also in washing agents for

textiles produced outside the

EU.

***

(Nonylphenol

ethoxylate is degraded

in the environment and

forms nonylphenol

(CAS No 25154-52-3

or 84852- 15-3).

Nonylphenol is

classified as inter alia

very dangerous for the

environment with

long-term adverse

effects. The substance

also has suspected

endocrine disruptive

properties.)

Octabromodiphenyl

ether (Octa-BDE)

(This is a PBDE)

32536-52-0 Repr. 1B;

H360Df

Repr.

Cat.2;

R61

Flame retardant Yes (see table 6)

Pentabromo

diphenyl ether

(Penta-BDE)

(This is a PBDE)

32534-81-9 Aquatic

Chronic 1;

H410

Lact;H362

N;R50-53

R64

Flame retardant Yes (see table 6)

***(suspected vPvB)

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Substance/

group of

substances

CAS No

Reasons for

avoiding the

substance Examples of use

Exemptions for

certain

applications CLP

KIFS

2005:7

Perfluorcarbons

Several Fire extinguishing agent

GWP >2000

Perfluorooctane

sulfonates and its

derivatives (PFOS)

C8F17SO2X

(X=OH, metal salt

(O-M+), halide,

amide, and other

Derivatives

including polymers)

Several Extinguishing agent,

impregnation of textiles, paper,

leather among other things for

stain protection.

PBT

Polybrominated

biphenyls (PBB)

such as 2,3,3´,4,4´,

5´-Hexabromo

biphenyl

Several

59536–65–

1

Textiles, leather and clothing.

Flame retardant in electrical

and electronic equipment.

Yes (see table 6)

***(suspected vPvB)

Polychlorinated

biphenyls (PCB)

Several Dielectric medium in

capacitors and transformers, in

sealants.

PBT/vPvB

Sulphur

hexafluoride

2551-62-4 Insulating medium in high

voltage equipment, switches,

transformers.

Yes (see table 6)

GWP >2000

1,1,2-

Trifluorotrichloro

ethane (Freon TF)

76-13-1 Solvent

Ozone depleting

potential

1,1,1-Trichloro

etane

71-55-6 Ozone:H4

20

N;R59 Solvent

Tri(2-chloroethyl)

phosphate

115-96-8 Repr. 1B;

H360F

Repr.Cat2

;R60

Flame retardant in plastic,

paint, lacquer and adhesives.

Part of building products,

furniture and textiles.

*

Trichloroethylene 79-01-06 Carc.1B;

H350

Carc.Cat2:

R45

Degreasing agent for metal,

solvent. (prohibited to use the

substance occupationally in

Sweden (SFS 1998:944)

*

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5. Examples of relevant legislation to consider

5.1. REACH (Regulation (EC) No 1907/2006)25

REACH is a regulation that came into force across the EU in June 2007, but the

requirements are being introduced gradually. REACH deals with registration,

evaluation, authorisation and restriction of chemical substances. The requirements

on users, manufacturer and importers of chemical products in REACH have no

counterpart in previous legislation.

REACH distinguishes between substances, mixtures and articles. REACH

primarily regulates substances and mixtures, i.e. chemical products, but some new

requirements also apply to the content of articles.

An article is defined (REACH article 3.3) as an object which during production is

given a special shape, surface or design, which determines its function to a greater

degree than does its chemical composition. A more thorough assessment of an

object’s function and properties may be required to establish whether an object

fulfils the definition of article under REACH. The European Chemicals Agency

(ECHA) has published guidance on requirements for substances in articles18,

which, among other things gives guidance on what should be seen as an article

and helps suppliers of articles to establish which requirements that must be

fulfilled for production, import and supply of articles.

An example of an article is the rubber handles of a bicycle. The complete bicycle

is a complex article, where several articles (for example the rubber handles, the

tyres, the frame) has been assembled to achieve a desired form, function and

design. Articles and complex articles that may occur in the defence sector are

various materiel such as ships, camouflage net, electrical fittings etc.

REACH has introduced provisions that certain information on substances of very

high concern included in articles shall be communicated to professional users

(article 33 in REACH). The provision applies if a substance has been identified as

particularly hazardous (also known as a SVHC, Substances of Very High

Concern) on the Candidate list, and the concentration in the article is above 0.1 %

weight by weight. The supplier of the article shall then provide the recipient of

25

REACH (Registration, Evaluation, Authorisation and restriction of CHemicals) is the globally

used abbreviation of Regulation (EC) No 1907/2006.

Note that this section only contains examples of relevant legislation to

consider. The supplier is responsible to comply with all Swedish legislation

and EU regulations and other rules applicable to the chemical product and/or

article.

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the article with sufficient information, available to the supplier, to allow safe use

of the article including, as a minimum, the name of that substance.

Note that Sweden and five other EU-countries have interpreted the concentration

limit 0.1 % weight by weight as below. This interpretation26

shall apply to

suppliers that make articles and complex articles available to the defence sector:

The concentration of the substance shall be determined as the ratio of the

weight of the substance and the weight of individual parts or

materials that are part of a complex article and that by themself is defined

as articles

For a complex article that consists of several parts, this means that the

basis for calculations has to be the weight of the individual part that

contains the substance, not the total weight of the complex article.

This way to calculate 0.1 % weight by weight of a substance in an article derives

from the concept “once an article, always an article”, i.e. an object that once has

become an article will normally be considered an article through the whole life

cycle.

When a substance on the Candidate list is listed in Annex XIV in REACH, this

means that the substance is not allowed to be used or placed on the market

without authorisation from the European Chemicals Agency, ECHA. Annex XIV

specifies a sunset date when the substance is not allowed to be used without

authorisation and a deadline for application for authorisation from ECHA.

5.2. CLP (Regulation (EC) No 1272/2008)27

CLP is a regulation that came into force in January 2009 across the EU. CLP

introduces new rules on how to classify, label and package chemical substances

and chemical products (substances or mixtures).

During a transitional period to 1 June 2015, different provisions regarding

classification, labelling and packaging apply to chemical products defined as

substances and mixtures respectively. Substances shall be classified according to

CLP no later than the 1 December 2010, and mixtures no later than the 1 June

2015.

26

The complete wording of the Swedish interpretation is to be found here: http://www.kemi.se/Documents/Forfattningar/Reach/Swedish%20interpretation%20of%20the%20

0.1%20per%20cent%20limit.pdf 27

CLP (Classification, Labelling and Packaging) is the globally used abbreviation of Regulation

(EC) No 1272/2008.

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Figure1: Timeline for the introduction of CLP.28

Until the 1 June 2015 mixtures shall be classified according to KIFS 2005:7 and

may be labelled and packaged according to KIFS 2005:7. By the side of

classification according to KIFS 2005:7, the mixture may also be classified

according to CLP. It shall then also be labelled and packaged according to CLP.

Note that the mixture shall be labelled and packaged according to either KIFS

2005:7 or CLP. Labelling according to both of the systems may not occur on the

same package.

If the mixture is classified, labelled and packaged according to CLP, the

classification of the chemical product shall be given together with the

classification according to KIFS 2005:7 in the safety data sheet.

Regarding the labelling of chemical products, CLP introduces several changes.

Hazard pictograms are used instead of danger symbols and the labelling shall also

include hazard statements and precautionary statements, instead of the risk and

safety phrases given in KIFS 2005:7. Indication of danger (e.g. Harmful) is

replaced by the signal words ”Danger” or ”Warning”.

28

http://www.echa.europa.eu/documents/10162/13562/clp_introductory_en.pdf

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5.3. Chemical Hazards in the Working Environment (AFS 2011:19)29

This Swedish provision has replaced ”AFS 2000:4 Chemical Hazards in the

Working Environment”. The appendix with substances to which requirements on

prohibition or permission apply (group A and group B substances) is moved from

“AFS 2005:17 Occupational exposure limit values and measures against air

contaminants” to AFS 2011:19.

Group A substances may not be handled, and group B substances may not be

handled without permission from the Swedish Work Environment Authority. It is

of major concern that substances in Group A and B is avoided in the activities

of the defence sector.

The rules emphasises the requirements on a systematic handling of chemical

hazards in the working environment. Obligations to investigate and assess risks,

take risk reducing measures, plan contingency for accidents, produce documents

and to label containers and pipelines are included in the provisions.

5.4. Thermosetting plastics (AFS 2005:18)30

The purpose of this Swedish provision is to prevent ill-health resulting from

exposure to thermosetting plastic components, certain thermoplastic components,

and air contaminants formed in connection with thermal degradation.

The provision applies to all activities which involves the handling of

thermosetting plastic components which because of their toxicological properties

constitute hazardous chemical substances as defined in the provisions of the

Swedish Work Environment Authority on Chemical Hazards in the Working

Environment.

The provision includes specific requirements on certain thermosetting plastic

components, such as: epoxy plastics, urethane plastics, acrylate plastics and

amino- and phenolic plastics.

29

http://www.av.se/dokument/inenglish/legislations/eng1119.pdf

30 http://www.av.se/dokument/inenglish/legislations/eng0518.pdf

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5.5. The Chemical Products (Handling, Import, and Export Prohibitions) Ordinance (SFS 1998:944)31

This Swedish ordinance contains specific prohibitions or other restrictions on the

handling of:

1. cadmium;

2. chlorinated solvents;

3. mercury;

4. cadmium, mercury, lead, hexavalent chromium and other chemical products in

electrical and electronic products and in batteries;

5. heavy metals in packaging material;

6. ammunition that contains lead,

7. textile detergents containing phosphates, and

8. certain other chemical products and goods dangerous to health or the

environment.

5.6. RoHS 2 (EU Directive 2011/65/EU)32

The new RoHS directive which apply from 2013 deals with restriction of the use

of certain hazardous substances in electrical and electronis equipment. Changes

from the previous RoHS directive are inter alia that more product groups are

included and that new criteria for exemptions are introduced.

Electrical and electronic equipment contains health- and environmentally

hazardous substances, which if they are distributed may affect the human health

and the environment. There is an increased risk for exposure and distribution of

hazardous substances when handling electrical and electronic waste. The purpose

of the RoHS directive is to replace mercury, cadmium, lead, chromium (VI) and

the flame retardants PBB and PBDE in electrical and electronic equipment with

less hazardous alternatives.

Swedish applications are introduced in the ordinance SFS 2012:861 and the

provisions KIFS 2008:2.

31 T

he ordinance is to be found at:

http://www2.kemi.se/upload/forfattningar/docs_eng/f98_944.pdf

32 RoHS 2 (Restriction of Hazardous Substances in Electrical and Electronic Equipment) is the

globally used abbreviation of Directive 2011/65/EU.