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Regulation (EC) No 1907/2006 of the European Parliament and of the CouncilShow full title

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance)

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a

OJ L 377, 31.12.1991, p. 20 . Directive as last amended by Regulation (EC) No 166/2006 of the European Parliament and of the Council ( OJ L 33, 4.2.2006, p. 1 ).

b

Chrysotile has two CAS Nos, confirmed by ECB.

c

Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff ( OJ L 256, 7.9.1987 ). Regulation as last amended by Regulation (EC) No 426/2006 ( OJ L 79, 16.3.2006, p. 1 ).

d

OJ L 147, 9.6.1975, p. 40 . Directive as last amended by Regulation (EC) No 807/2003 ( OJ L 122, 16.5.2003, p. 36 ).

e

For the purposes of this point childcare article shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.]

Designation of the substance, of the groups of substances or of the preparation Conditions of restriction

1. Polychlorinated terphenyls (PCTs)

  • Preparations, including waste oils, with a PCT content higher than 0,005 % by weight.

1. Shall not be used. However, the following use of equipment, installations and fluids which were in service on 30 June 1986 shall continue to be permitted until they are disposed of or reach the end of their service life:

(a)

closed-system electrical equipment transformers, resistors and inductors;

(b)

large condensers (≥ 1 kg total weight);

(c)

small condensers;

(d)

heat-transmitting fluids in closed-circuit heat-transfer installations;

(e)

hydraulic fluids for underground mining equipment.

2. The Member State may, for reasons of protection of human health and the environment, prohibit the use of equipment, installations and fluids covered by paragraph 1 before they are disposed of or reach the end of their service life.

3. The placing on the second-hand market of equipment, plant and fluids covered by paragraph 1 which are not intended for disposal shall be prohibited.

4. Where the Member State considers that it is not possible for technical reasons to use substitute articles, it may permit the use of PCTs and preparations thereof where the latter are solely intended, in the normal conditions of maintenance of equipment, to supplement the level of liquids containing PCTs in properly functioning existing installations purchased before 1 October 1985 .

5. The Member State may, provided prior notification stating the reasons is sent to the Commission, grant derogations from the ban on the placing on the market and use of primary and intermediate substances or preparations, in so far as they consider that these derogations have no deleterious effects on human health and the environment.

6. Without prejudice to the implementation of other Community provisions relating to the labelling of dangerous substances and preparations, equipment and installations containing PCTs must also display instructions concerning the disposal of PCTs and the maintenance and use of equipment and installations containing them. These instructions must be capable of being read horizontally when the object containing the PCTs is installed in the normal way. The inscription must stand out clearly from its background and shall be in a language which is understood in the territory where it is being used.

2. Chloro-1-ethylene (monomer vinyl chloride)

CAS No 75-01-4

EINECS No 200-831-0

Shall not be used as aerosol propellant for any use.

3. Liquid substances or preparations, which are regarded as dangerous according to the definitions in Council Directive 67/548/EEC and Directive 1999/45/EC.

1. Shall not be used in:

  • ornamental objects, intended to produce light or colour effects by means of different phases, for example in ornamental lamps and ashtrays,

  • tricks and jokes,

  • games for one or more participants, or any object intended to be used as such, even with ornamental aspects.

2. Without prejudice to paragraph 1, substances and preparations which:

  • present an aspiration hazard and are labelled with R65, and

  • can be used as fuel in decorative lamps, and

  • are placed on the market in packaging of a capacity of 15 litres or less,

shall not contain a colouring agent, unless required for fiscal reasons, or perfume or both.

3. Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of dangerous substances and preparations, the packaging of substances and preparations covered by paragraph 2, where intended for use in lamps, must be marked legibly and indelibly as follows:

Keep lamps filled with this liquid out of the reach of children .

4. Tris (2,3 dibromopropyl) phosphate

CAS No 126-72-7

Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.

5. Benzene

CAS No 71-43-2

EINECS No 200-753-785

1. Not permitted in toys or parts of toys as placed on the market where the concentration of benzene in the free state is in excess of 5 mg/kg of the weight of the toy or part of toy.

2. Shall not be used in concentrations equal to, or greater than, 0,1 % by mass in substances or preparations placed on the market.

3. However, paragraph 2 shall not apply to:

(a)

motor fuels which are covered by Directive 98/70/EC;

(b)

substances and preparations for use in industrial processes not allowing for the emission of benzene in quantities in excess of those laid down in existing legislation;

(c)

waste covered by Council Directive 91/689/EEC of 12 December 1991 on hazardous waste a and Directive 2006/12/EC.

6. Asbestos fibres

(a)

Crocidolite

CAS No 12001-28-4

(b)

Amosite

CAS No 12172-73-5

(c)

Anthophyllite

CAS No 77536-67-5

(d)

Actinolite

CAS No 77536-66-4

(e)

Tremolite

CAS No 77536-68-6

(f)

Chrysotile b

CAS No 12001-29-5

CAS No 132207-32-0

1. The placing on the market and use of these fibres and of articles containing these fibres added intentionally shall be prohibited.

However, Member States may except the placing on the market and use of diaphragms containing chrysotile (point (f)) for existing electrolysis installations until they reach the end of their service life, or until suitable asbestos-free substitutes become available, whichever is the sooner. The Commission will review this derogation before 1 January 2008 .

2. The use of articles containing asbestos fibres referred to in paragraph 1 which were already installed and/or in service before 1 January 2005 shall continue to be permitted until they are disposed of or reach the end of their service life. However, Member States may, for reasons of protection of human health, prohibit the use of such articles before they are disposed of or reach the end of their service life.

Member States shall not permit the introduction of new applications for chrysotile asbestos on their territories.

3. Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the placing on the market and use of these fibres and of articles containing these fibres, as permitted according to the preceding derogations, shall be permitted only if the articles bear a label in accordance with the provisions of Appendix 7 to this Annex.

7. Tris(aziridinyl)phosphinoxide

CAS No 5455-55-1

Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.

8. Polybromobiphenyls; Polybrominatedbiphenyls (PBB)

CAS No 59536-65-1

9. Soap bark powder (Quillaja saponaria) and its derivatives containing saponines

Powder of the roots of Helleborus viridis and Helleborus niger

Powder of the roots of Veratrum album and Veratrum nigrum

Benzidine and/or its derivatives

CAS No 92-87-5

EINECS No 202-199-1

o -Nitrobenzaldehyde

CAS No 552-89-6

Wood powder

1. Shall not be used in jokes and hoaxes or in objects intended to be used as such, for instance as a constituent of sneezing powder and stink bombs.

2. However, paragraph 1 does not apply to stink bombs containing not more than 1,5 ml of liquid.

10. Ammonium sulphide

CAS No 12135-76-1

Ammonium hydrogen sulphide

CAS No 12124-99-1

Ammonium polysulphide

CAS No 9080-17-5

EINECS No 232-989-1

11. Volatile esters of bromoacetic acids:

  • Methyl bromoacetate

  • CAS No 96-32-2

  • EINECS No 202-499-2

  • Ethyl bromoacetate

  • CAS No 105-36-2

  • EINECS No 203-290-9

  • Propyl bromoacetate

  • CAS No 35223-80-4

  • Butyl bromoacetate

12. 2-Naphthylamine

CAS No 91-59-8

EINECS No 202-080-4

and its salts

13. Benzidine

CAS No 92-87-5

EINECS No 202-199-1

and its salts

14. 4-Nitrobiphenyl

CAS No 92-93-3

EINECS No 202-204-7

15. 4-Aminobiphenyl xenylamine

CAS No 92-67-1

EINECS No 202-177-1

and its salts

1. Shall not be used in concentrations equal to or greater than 0,1 % by weight in substances and preparations placed on the market.

However, this provision shall not apply to waste containing one or more of these substances and covered by Directives 91/689/EEC and 2006/12/EC.

2. Such substances and preparations shall not be sold to the general public.

3 Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of such preparations shall be legible and indelibly marked as follows:

Restricted to professional users .

16. Lead carbons:

(a)

Neutral anhydrous carbonate (PbCO 3 )

CAS No 598-63-0

EINECS No 209-943-4

(b)

Trilead-bis(carbonate)-dihydroxide 2 Pb CO 3 -Pb(OH) 2

CAS No 1319-46-6

EINECS No 215-290-6

Shall not be used as substances and a constituent of preparations intended for use as paints, except for the restoration and maintenance of works of art and historic buildings and their interiors, where Member States wish to permit this on their territory, in accordance with the provisions of ILO Convention 13 on the use of white lead and sulphates of lead in paint.

17. Lead sulphates

(a)

PbSO 4 (1:1)

CAS No 7446-14-2

EINECS No 231-198-9

(b)

Pb x SO 4

CAS No 15739-80-7

EINECS No 239-831-0

18. Mercury compounds

1. Shall not be used as substances and constituents of preparations intended for use:

(a)

to prevent the fouling by micro-organisms, plants or animals of:

  • the hulls of boats,

  • cages, floats, nets and any other appliances or equipment used for fish or shellfish farming,

  • any totally or partly submerged appliances or equipment;

(b)

in the preservation of wood;

(c)

in the impregnation of heavy-duty industrial textiles and yarn intended for their manufacture;

(d)

in the treatment of industrial waters, irrespective of their use.

2. The placing on the market of batteries and accumulators, containing more than 0,0005 % of mercury by weight, including in those cases where these batteries and accumulators are incorporated into appliances shall be prohibited. Button cells and batteries composed of button cells with a mercury content of no more than 2 % by weight shall be exempted from this prohibition.

19. Arsenic compounds

1. Shall not be used as substances and constituents of preparations intended for use:

(a)

to prevent the fouling by micro-organisms, plants or animals of:

  • the hulls of boats,

  • cages, floats, nets and any other appliances or equipment used for fish or shellfish farming,

  • any totally or partly submerged appliances or equipment;

(b)

in the preservation of wood. Furthermore, wood so treated shall not be placed on the market;

(c)

however, by way of derogation:

(i)

Relating to the substances and preparations in the preservation of wood: these may only be used in industrial installations using vacuum or pressure to impregnate wood if they are solutions of inorganic compounds of the copper, chromium, arsenic (CCA) type C. Wood so treated shall not be placed on the market before fixation of the preservative is completed.

(ii)

Relating to wood treated with CCA solutions in industrial installations according to point (i): this may be placed on the market for professional and industrial use provided that the structural integrity of the wood is required for human or livestock safety and skin contact by the general public during its service life is unlikely:

  • as structural timber in public and agricultural buildings, office buildings, and industrial premises,

  • in bridges and bridgework,

  • as constructional timber in freshwater areas and brackish waters e.g. jetties and bridges,

  • as noise barriers,

  • in avalanche control,

  • in highway safety fencing and barriers,

  • as debarked round conifer livestock fence posts,

  • in earth retaining structures,

  • as electric power transmission and telecommunications poles,

  • as underground railway sleepers.

Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, all treated wood placed on the market shall be individually labelled For professional and industrial installation and use only, contains arsenic . In addition, all wood placed on the market in packs shall also bear a label stating Wear gloves when handling this wood. Wear a dust mask and eye protection when cutting or otherwise crafting this wood. Waste from this wood shall be treated as hazardous by an authorised undertaking .

(iii)

Treated wood referred to under points (i) and (ii) shall not be used:

  • in residential or domestic constructions, whatever the purpose,

  • in any application where there is a risk of repeated skin contact,

  • in marine waters,

  • for agricultural purposes other than for livestock fence posts and structural uses in accordance with point (ii),

  • in any application where the treated wood may come into contact with intermediate or finished products intended for human and/or animal consumption.

2. Shall not be used as substances and constituents of preparations intended for use in the treatment of industrial waters, irrespective of their use.

20. Organostannic compounds

1. Shall not be placed on the market for use as substances and constituents of preparations when acting as biocides in free association paint.

2. Shall not be placed on the market or used as substances and constituents of preparations which act as biocides to prevent the fouling by micro-organisms, plants or animals of:

(a)

all craft irrespective of their length intended for use in marine, coastal, estuarine and inland waterways and lakes;

(b)

cages, floats, nets and any other appliances or equipment used for fish or shellfish farming;

(c)

any totally or partly submerged appliance or equipment.

3. Shall not be used as substances and constituents of preparations intended for use in the treatment of industrial waters.

21. Di-μ-oxo-di-n-butylstanniohydroxyborane dibutyltin hydrogen borate C 8 H 19 BO 3 S n (DBB)

CAS No 75113-37-0

ELINCS No 401-040-5

Shall be prohibited in a concentration equal to or greater than 0,1 % in substances and constituents of preparations placed on the market. However, this provision shall not apply to this substance (DBB) or preparations containing it if these are intended solely for conversion into finished articles, among which this substance will no longer feature in a concentration equal to or greater than 0,1 %.

22. Pentachlorophenol

CAS No 87-86-5

EINECS No 201-778-6

and its salts and esters

1. Shall not be used in a concentration equal to or greater than 0,1 % by mass in substances or preparations placed on the market.

2. Transitional provisions:

By way of derogation until 31 December 2008 France, Ireland, Portugal, Spain and the United Kingdom may chose not to apply this provision to substances and preparations intended for use in industrial installations not permitting the emission and/or discharge of pentachlorophenol (PCP) in quantities greater than those prescribed by existing legislation:

(a)

in the treatment of wood.

However, treated wood shall not be used:

  • inside buildings whether for decorative purposes or not, whatever their purpose (residence, employment, leisure),

  • for the manufacture and re-treatment of:

    (i)

    containers intended for growing purposes;

    (ii)

    packaging that may come into contact with raw materials, intermediate or finished products destined for human and/or animal consumption;

    (iii)

    other materials that may contaminate the products mentioned in (i) and (ii);

(b)

in the impregnation of fibres and heavy-duty textiles not intended in any case for clothing or for decorative furnishings;

(c)

by way of special exception, Member States may on a case-by-case basis, permit on their territory specialised professionals to carry out in situ and for buildings of cultural, artistic and historical interest, or in emergencies, a remedial treatment of timber and masonry infected by dry rot fungus (Serpula lacrymans) and cubic rot fungi.

In any case:

(a)

Pentachlorophenol used alone or as a component of preparations employed within the framework of the above exceptions must have a total hexachlorodibenzoparadioxin (HCDD) content of not more than two parts per million (ppm);

(b)

these substances and preparations shall not:

  • be placed on the market except in packages of 20 litres or more;

  • be sold to the general public.

3. Without prejudice to the implementation of other Community provisions concerning the classification, packaging and labelling of dangerous substances and preparations, the packaging of substances and preparations covered by paragraphs 1 and 2 shall be marked clearly and indelibly:

Reserved for industrial and professional use .

This provision shall not apply to waste covered by Directives 91/689/EEC and 2006/12/EC.

23. Cadmium

CAS No 7440-43-9

EINECS No 231-152-8

and its compounds

1. Shall not be used to give colour to finished articles manufactured from the substances and preparations listed below:

(a)
  • polyvinyl chloride (PVC) [ 3904 10 ] [ 3904 21 ] [ 3904 22 ] c ,

  • polyurethane (PUR) [ 3909 50 ] c ,

  • low-density polyethylene (ld PE), with the exception of low-density polyethylene used for the production of coloured masterbatch [ 3901 10 ] c ,

  • cellulose acetate (CA) [ 3912 11 ] [ 3912 12 ] c ,

  • cellulose acetate butyrate (CAB) [ 3912 11 ] [ 3912 12 ] c ,

  • epoxy resins [ 3907 30 ] c ,

  • melamine — formaldehyde (MF) resins [ 3909 20 ] c ,

  • urea — formaldehyde (UF) resins [ 3909 10 ] c ,

  • unsaturated polyesters (UP) [ 3907 91 ] c ,

  • polyethylene terephthalate (PET) [ 3907 60 ] c ,

  • polybutylene terephthalate (PBT) c ,

  • transparent/general-purpose polystyrene [ 3903 11 ] [ 3903 19 ] c ,

  • acrylonitrile methylmethacrylate (AMMA) c ,

  • cross-linked polyethylene (VPE) c ,

  • high-impact polystyrene c ,

  • polypropylene (PP) [ 3902 10 ] c ;

(b)

paints [ 3208 ] [ 3209 ] c .

However, if the paints have a high zinc content, their residual concentration of cadmium shall be as low as possible and shall at all events not exceed 0,1 % by mass.

In any case, whatever their use or intended final purpose, finished articles or components of articles manufactured from the substances and preparations listed above coloured with cadmium shall not be placed on the market if their cadmium content (expressed as Cd metal) exceeds 0,01 % by mass of the plastic material.

2. However, paragraph 1 does not apply to articles to be coloured for safety reasons.

3. Shall not be used to stabilise the finished articles listed below manufactured from polymers or copolymers of vinyl chloride:

  • packaging materials (bags, containers, bottles, lids) [ 3923 29 10 ] [ 3920 41 ] [ 3920 42 ] c ,

  • office or school supplies [ 3926 10 ] c ,

  • fittings for furniture, coachwork or the like [ 3926 30 ] c ,

  • articles of apparel and clothing accessories (including gloves) [ 3926 20 ] c ,

  • floor and wall coverings [ 3918 10 ] c ,

  • impregnated, coated, covered or laminated textile fabrics [ 5903 10 ] c ,

  • imitation leather [ 4202 ] c ,

  • gramophone records [ 8524 10 ] c ,

  • tubes and pipes and their fittings [ 3917 23 ] c ,

  • swing doors c ,

  • vehicles for road transport (interior, exterior, underbody) c ,

  • coating of steel sheet used in construction or in industry c ,

  • insulation for electrical wiring c .

In any case, whatever their use or intended final purpose, the placing on the market of the above finished articles or components of articles manufactured from polymers or copolymers of vinyl chloride, stabilised by substances containing cadmium shall be prohibited, if their cadmium content (expressed as Cd metal) exceeds 0,01 % by mass of the polymer.

4. However, paragraph 3 does not apply to finished articles using cadmium-based stabilisers for safety reasons.

5. Within the meaning of this Regulation, cadmium plating means any deposit or coating of metallic cadmium on a metallic surface.

Shall not be used for cadmium plating metallic articles or components of the articles used in the sectors/applications listed below:

(a)

equipment and machinery for:

  • food production [ 8210 ] [ 8417 20 ] [ 8419 81 ] [ 8421 11 ] [ 8421 22 ] [ 8422 ] [ 8435 ] [ 8437 ] [ 8438 ] [ 8476 11 ] c ,

  • agriculture [ 8419 31 ] [ 8424 81 ] [ 8432 ] [ 8433 ] [ 8434 ] [ 8436 ] c ,

  • cooling and freezing [ 8418 ] c ,

  • printing and book-binding [ 8440 ] [ 8442 ] [ 8443 ] c ;

(b)

equipment and machinery for the production of:

  • household goods [ 7321 ] [ 8421 12 ] [ 8450 ] [ 8509 ] [ 8516 ] c ,

  • furniture [ 8465 ] [ 8466 ] [ 9401 ] [ 9402 ] [ 9403 ] [ 9404 ] c ,

  • sanitary ware [ 7324 ] c ,

  • central heating and air conditioning plant [ 7322 ] [ 8403 ] [ 8404 ] [ 8415 ] c .

In any case, whatever their use or intended final purpose, the placing on the market of cadmium-plated articles or components of such articles used in the sectors/applications listed in points (a) and (b) above and of articles manufactured in the sectors listed in point (b) above shall be prohibited.

6. The provisions referred to in paragraph 5 are also applicable to cadmium-plated articles or components of such articles when used in the sectors/applications listed in points (a) and (b) below and to articles manufactured in the sectors listed in (b) below:

(a)

equipment and machinery for the production of:

  • paper and board [ 8419 32 ] [ 8439 ] [ 8441 ] c ,

  • textiles and clothing [ 8444 ] [ 8445 ] [ 8447 ] [ 8448 ] [ 8449 ] [ 8451 ] [ 8452 ] c ;

(b)

equipment and machinery for the production of:

  • industrial handling equipment and machinery [ 8425 ] [ 8426 ] [ 8427 ] [ 8428 ] [ 8429 ] [ 8430 ] [ 8431 ] c ,

  • road and agricultural vehicles [chapter 87] c ,

  • rolling stock [chapter 86] c ,

  • vessels [chapter 89] c .

7. However, the restrictions in paragraphs 5 and 6 do not apply to:

  • articles and components of the articles used in the aeronautical, aerospace, mining, offshore and nuclear sectors whose applications require high safety standards and in safety devices in road and agricultural vehicles, rolling stock and vessels,

  • electrical contacts in any sector of use, on account of the reliability required of the apparatus on which they are installed.

Owing to the development of knowledge and techniques in respect of substitutes less dangerous than cadmium and its compounds, the Commission shall, in consultation with the Member States, assess the situation at regular intervals in accordance with the procedure laid down in Article 133(3) of this Regulation.

24. Monomethyl — tetrachlorodiphenyl methane

Trade name: Ugilec 141

CAS No 76253-60-6

1. The placing on the market and use of this substance and of preparations and articles containing it shall be prohibited.

2. By way of exception paragraph 1 shall not apply:

(a)

in the case of plant and machinery already in service on 18 June 1994 until such plant and machinery is disposed of.

However, Member States may, on grounds of human health protection and environmental protection, prohibit within their territory the use of such plant or machinery before it is disposed of;

(b)

in the case of the maintenance of plant and machinery already in service within a Member State on 18 June 1994 .

3. The placing on the second-hand market of this substance, preparations containing this substance and plant/machinery containing this substance, shall be prohibited.

25. Monomethyl-dichloro-diphenyl methane

Trade name: Ugilec 121, Ugilec 21;

CAS No — unknown

The placing on the market and use of this substance and of preparations and articles containing it shall be prohibited.

26. Monomethyl-dibromo-diphenyl methane bromobenzylbromotoluene, mixture of isomers

Trade name: DBBT

CAS No 99688-47-8

The placing on the market and use of this substance and of preparations and articles containing it shall be prohibited.

27. Nickel

CAS No 7440-02-0

EINECS No 231-111-4

and its compounds

1. Shall not be used:

(a)

in all post assemblies which are inserted into pierced ears and other pierced parts of the human body unless the rate of nickel release from such post assemblies is less than 0,2 μg/cm 2 /week (migration limit);

(b)

in articles intended to come into direct and prolonged contact with the skin such as:

  • earrings,

  • necklaces, bracelets and chains, anklets, finger rings,

  • wrist-watch cases, watch straps and tighteners,

  • rivet buttons, tighteners, rivets, zippers and metal marks, when these are used in garments,

  • if the rate of nickel release from the parts of these articles coming into direct and prolonged contact with the skin is greater than 0,5 μg/cm 2 /week;

(c)

in articles such as those listed in point (b) where these have a non-nickel coating unless such coating is sufficient to ensure that the rate of nickel release from those parts of such articles coming into direct and prolonged contact with the skin will not exceed 0,5 μg/cm 2 /week for a period of at least two years of normal use of the article.

2. Articles which are the subject of paragraph 1, shall not be placed on the market unless they conform to the requirements set out in those points.

3. The standards adopted by the European Committee for Standardisation (CEN) shall be used as the test methods for demonstrating the conformity of articles to paragraphs 1 and 2.

28. Substances which appear in Annex I to Directive 67/548/EEC classified as carcinogen category 1 or carcinogen category 2 and labelled at least as Toxic (T) with risk phrase R 45: May cause cancer or risk phrase R49: May cause cancer by inhalation, and listed as follows:

  • Carcinogen category 1 listed in Appendix 1.

  • Carcinogen category 2 listed in Appendix 2.

Without prejudice to the other parts of this Annex the following shall apply to entries 28 to 30:

1. Shall not be used in substances and preparations placed on the market for sale to the general public in individual concentration equal to or greater than:

  • either the relevant concentration specified in Annex I to Directive 67/548/EEC, or

  • the relevant concentration specified in Directive 1999/45/EC.

29. Substances which appear in Annex I to Directive 67/548/EEC classified as mutagen category 1 or mutagen category 2 and labelled with risk phrase R46: May cause heritable genetic damage, and listed as follows:

  • Mutagen category 1 listed in Appendix 3.

  • Mutagen category 2 listed in Appendix 4.

Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of dangerous substances and preparations, the packaging of such substances and preparations must be marked legibly and indelibly as follows:

Restricted to professional users .

30. Substances which appear in Annex I to Directive 67/548/EEC classified as toxic to reproduction category 1 or toxic to reproduction category 2 and labelled with risk phrase R60: May impair fertility and/or R61: May cause harm to the unborn child, and listed as follows:

  • Toxic to reproduction category 1 listed in Appendix 5.

  • Toxic to reproduction category 2 listed in Appendix 6.

2. By way of derogation, paragraph 1 shall not apply to:

(a)

medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/EC;

(b)

cosmetic products as defined by Council Directive 76/768/EEC;

(c)
  • motor fuels which are covered by Directive 98/70/EC,

  • mineral oil products intended for use as fuel in mobile or fixed combustion plants,

  • fuels sold in closed systems (e.g. liquid gas bottles);

(d)

artists' paints covered by Directive 1999/45/EC.

31.

(a)

creosote; wash oil

CAS No 8001-58-9

EINECS No 232-287-5

(b)

creosote oil; wash oil

CAS No 61789-28-4

EINECS No 263-047-8

(c)

distillates (coal tar), naphthalene oils; naphthalene oil

CAS No 84650-04-4

EINECS No 283-484-8

(d)

creosote oil, acenaphthene fraction; wash oil

CAS No 90640-84-9

EINECS No 292-605-3

(e)

distillates (coal tar), upper; heavy anthracene oil

CAS No 65996-91-0

EINECS No 266-026-1

(f)

anthracene oil

CAS No 90640-80-5

EINECS No 292-602-7

(g)

tar acids, coal, crude; crude phenols

CAS No 65996-85-2

EINECS No 266-019-3

(h)

creosote, wood

CAS No 8021-39-4

EINECS No 232-419-1

(i)

low temperature tar oil, alkaline; extract residues (coal), low temperature coal tar alkaline

CAS No 122384-78-5

EINECS No 310-191-5

1. Shall not be used as substances or in preparations in the treatment of wood. Furthermore, wood so treated shall not be placed on the market.

2. However by way of derogation:

(a)

relating to the substances and preparations: these may be used for wood treatment in industrial installations or by professionals covered by Community legislation on the protection of workers for in situ retreatment only if they contain:

(i)

benzo[a]pyrene at a concentration of less than 0,005 % by mass;

(ii)

and water extractable phenols at a concentration of less than 3 % by mass.

Such substances and preparations for use in wood treatment in industrial installations or by professionals:

  • may be placed on the market only in packaging of a capacity equal to or greater than 20 litres,

  • shall not be sold to consumers.

Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of such substances and preparations shall be legibly and indelibly marked as follows:

For use in industrial installations or professional treatment only .

(b)

relating to wood treated in industrial installations or by professionals according to point (a) which is placed on the market for the first time or retreated in situ : this is permitted for professional and industrial use only, e.g. on railways, in electric power transmission and telecommunications, for fencing, for agricultural purposes (e.g. stakes for tree support) and in harbours and waterways;

(c)

the prohibition in paragraph 1 on the placing on the market shall not apply to wood which has been treated with substances listed in entry 31(a) to (i) before 31 December 2002 and is placed on the second-hand market for re-use.

3. However, treated wood referred to under paragraph 2(b) and (c) shall not be used:

  • inside buildings, whatever their purpose,

  • in toys,

  • in playgrounds,

  • in parks, gardens, and outdoor recreational and leisure facilities where there is a risk of frequent skin contact,

  • in the manufacture of garden furniture such as picnic tables,

  • for the manufacture and use and any re-treatment of:

    • containers intended for growing purposes,

    • packaging that may come into contact with raw materials, intermediate or finished products destined for human and/or animal consumption,

    • other materials which may contaminate the articles mentioned above.

32. Chloroform

CAS No 67-66-3

EINECS No 200-663-8

33. Carbon tetrachloride-tetrachloromethane

CAS No 56-23-5

EINECS No 200-262-8

34. 1,1,2 Trichloroethane

CAS No 79-00-5

EINECS No 201-166-9

35. 1,1,2,2 Tetrachloroethane

CAS No 79-34-5

EINECS No 201-197-8

36. 1,1,1,2 Tetrachloroethane

CAS No 630-20-6

37. Pentachloroethane

CAS No 76-01-7

EINECS No 200-925-1

38. 1,1 Dichloroethylene

CAS No 75-35-4

EINECS No 200-864-0

39. 1,1,1 Trichloroethane, methyl chloroform

CAS No 71-55-6

EINECS No 200-756-3

1. Shall not be used in concentrations equal to or greater than 0,1 % by weight in substances and preparations placed on the market for sale to the general public and/or in diffusive applications such as in surface cleaning and cleaning of fabrics.

2. Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of such substances and preparations containing them in concentrations equal to or greater than 0,1 % shall be legible and indelibly marked as follows:

For use in industrial installations only .

By way of derogation this provision shall not apply to:

(a)

medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/EC;

(b)

cosmetic products as defined by Directive 76/768/EEC.

40. Substances meeting the criteria of flammability in Directive 67/548/EEC and classified as flammable, highly flammable or extremely flammable regardless of whether they appear in Annex I to that Directive or not.

1 Shall not be used on their own or in the form of preparations in aerosol generators that are placed on the market for the general public for entertainment and decorative purposes such as the following:

  • metallic glitter intended mainly for decoration,

  • artificial snow and frost,

  • whoopee cushions,

  • silly string aerosols,

  • imitation excrement,

  • horn for parties,

  • decorative flakes and foams,

  • artificial cobwebs,

  • stink bombs,

  • etc.

2. Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances, the following words must appear legibly and indelibly on the packaging of aerosol generators referred to above:

For professional users only .

3. By way of derogation, paragraphs 1 and 2 shall not apply to the aerosol generators referred to in Article 9a of Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers d .

4. The articles referred to in paragraphs 1 and 2 shall not be placed on the market unless they conform to the requirements indicated.

41. Hexachloroethane

CAS No 67-72-1

EINECS No 200-6664

Shall not be used in the manufacturing or processing of non-ferrous metals.

42. Alkanes, C 10 -C 13 , chloro (short-chain chlorinated paraffins) (SCCPs)

EINECS No 287-476-5

Shall not be placed on the market for use as substances or as constituents of other substances or preparations in concentrations higher than 1 %:

  • in metalworking,

  • for fat liquoring of leather.

43. Azocolourants

1. Azodyes which, by reductive cleavage of one or more azo groups, may release one or more of the aromatic amines listed in Appendix 8, in detectable concentrations, i.e. above 30 ppm in the finished articles or in the dyed parts thereof, according to the testing methods listed in Appendix 10, shall not be used in textile and leather articles which may come into direct and prolonged contact with the human skin or oral cavity, such as:

  • clothing, bedding, towels, hairpieces, wigs, hats, nappies and other sanitary items, sleeping bags,

  • footwear, gloves, wristwatch straps, handbags, purses/wallets, briefcases, chair covers, purses worn round the neck,

  • textile or leather toys and toys which include textile or leather garments,

  • yarn and fabrics intended for use by the final consumer.

2. Furthermore, the textile and leather articles referred to in paragraph 1 above shall not be placed on the market unless they conform to the requirements set out in that paragraph.

3. Azodyes, which are contained in Appendix 9, List of azodyes , shall not be placed on the market or used for colouring textile and leather articles as a substance or constituent of preparations in concentrations higher than 0,1 % by mass.

4. The Commission shall, in the light of new scientific knowledge, review the provisions on azocolourants.

44. Diphenylether, pentabromo derivative C 12 H 5 Br 5 O

1. Shall not be placed on the market or used as a substance or as a constituent of preparations in concentrations higher than 0,1 % by mass.

2. Articles may not be placed on the market if they, or flame-retarded parts thereof, contain this substance in concentrations higher than 0,1 % by mass.

45. Diphenylether, octabromo derivative C 12 H 2 Br 8 O

1. Shall not be placed on the market or used as a substance or as a constituent of substances or of preparations in concentrations higher than 0,1 % by mass.

2. Articles may not be placed on the market if they, or flame-retardant parts thereof, contain this substance in concentrations higher than 0,1 % by mass.

46.

(a)

Nonylphenol C 6 H 4 (OH)C 9 H 19

(b)

Nonylphenol ethoxylate (C 2 H 4 O) n C 15 H 24 O

Shall not be placed on the market or used as a substance or constituent of preparations in concentrations equal or higher than 0,1 % by mass for the following purposes:

(1)

industrial and institutional cleaning except:

  • controlled closed dry cleaning systems where the washing liquid is recycled or incinerated,

  • cleaning systems with special treatment where the washing liquid is recycled or incinerated;

(2)

domestic cleaning;

(3)

textiles and leather processing except:

  • processing with no release into waste water,

  • systems with special treatment where the process water is pre-treated to remove the organic fraction completely prior to biological waste water treatment (degreasing of sheepskin);

(4)

emulsifier in agricultural teat dips;

(5)

metal working except:

  • uses in controlled closed systems where the washing liquid is recycled or incinerated;

(6)

manufacturing of pulp and paper;

(7)

cosmetic products;

(8)

other personal care products except:

  • spermicides;

(9)

co-formulants in pesticides and biocides.

47. Cement

1. Cement and cement-containing preparations shall not be used or placed on the market, if they contain, when hydrated, more than 0,0002 % soluble chromium VI of the total dry weight of the cement.

2. If reducing agents are used, then without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of cement or cement-containing preparations shall be legibly and indelibly marked with information on the packing date, as well as on the storage conditions and the storage period appropriate to maintaining the activity of the reducing agent and to keeping the content of soluble chromium VI below the limit indicated in paragraph 1.

3. By way of derogation, paragraphs 1 and 2 shall not apply to the placing on the market for, and use in, controlled closed and totally automated processes in which cement and cement-containing preparations are handled solely by machines and in which there is no possibility of contact with the skin.

48. Toluene

CAS No 108-88-3

Shall not be placed on the market or used as a substance or constituent of preparations in a concentration equal to or higher than 0,1 % by mass in adhesives and spray paints intended for sale to the general public.

Member States shall apply these measures from 15 June 2007 .

49. Trichlorobenzene

CAS No 120-82-1

Shall not be placed on the market or used as a substance or constituent of preparations in a concentration equal to or higher than 0,1 % by mass for all uses except:

  • as an intermediate of synthesis, or

  • as a process solvent in closed chemical applications for chlorination reactions, or

  • in the manufacture of 1,3,5 — trinitro — 2,4,6 — triaminobenzene (TATB).

Member States shall apply these measures from 15 June 2007 .

50. Polycyclic-aromatic hydrocarbons (PAH)

1.

Benzo(a)pyrene (BaP)

CAS No 50-32-8

2.

Benzo(e)pyrene (BeP)

CAS No 192-97-2

3.

Benzo(a)anthracene (BaA)

CAS No 56-55-3

4.

Chrysen (CHR)

CAS No 218-01-9

5.

Benzo(b)fluoranthene (BbFA)

CAS No 205-99-2

6.

Benzo(j)fluoranthene (BjFA)

CAS No 205-82-3

7.

Benzo(k)fluoranthene (BkFA)

CAS No 207-08-9

8.

Dibenzo(a, h)anthracene (DBAhA)

CAS No 53-70-3

1. Extender oils shall not be placed on the market and used for the production of tyres or parts of tyres, if they contain:

  • more than 1 mg/kg BaP, or

  • more than 10 mg/kg of the sum of all listed PAHs.

These limits are regarded as kept, if the polycyclic aromatics (PCA) extract is less than 3 % by mass, as measured by the Institute of Petroleum standard IP346: 1998 (Determination of PCA in unused lubricating base oils and asphaltene free petroleum fractions — Dimethyl sulphoxide extraction refractive index method), provided that compliance with the limit values of BaP and of the listed PAHs, as well as the correlation of the measured values with the PCA extract, is controlled by the manufacturer or importer every six months or after each major operational change, whichever is earlier.

2. Furthermore, the tyres and treads for retreading manufactured after 1 January 2010 may not be placed on the market if they contain extender oils exceeding the limits indicated in paragraph 1.

These limits are regarded as kept, if the vulcanised rubber compounds do not exceed the limit of 0,35 % Bay protons as measured and calculated by ISO 21461 (Rubber vulcanised — Determination of aromaticity of oil in vulcanised rubber compounds).

3. By way of derogation, paragraph 2 shall not apply to retreaded tyres if their tread does not contain extender oils exceeding the limits referred to in paragraph 1.

4. Member States shall apply these measures from 1 January 2010 .

51. The following phthalates (or other CAS- and EINECS numbers covering the substance):

  • bis (2-ethylhexyl) phthalate (DEHP)

  • CAS No 117-81-7

  • Einecs No 204-211-0

  • dibutyl phthalate (DBP)

  • CAS No 84-74-2

  • Einecs No 201-557-4

  • benzyl butyl phthalate (BBP)

  • CAS No 85-68-7

  • Einecs No 201-622-7

Shall not be used as substances or as constituents of preparations, at concentrations higher than 0,1 % by mass of the plasticised material, in toys and childcare articles e .

Toys and childcare articles containing these phthalates in a concentration higher than 0,1 % by mass of the plasticised material shall not be placed on the market.

The Commission shall re-evaluate, by 16 January 2010 , the measures provided for in relation to this point in the light of new scientific information on such substances and their substitutes, and if justified, these measures shall be modified accordingly.

52. The following phthalates (or other CAS- and EINECS numbers covering the substance):

  • di- isononyl phthalate (DINP)

  • CAS No 28553-12-0 and 68515-48-0

  • Einecs No 249-079-5 and 271-090-9

  • di- isodecyl phthalate (DIDP)

  • CAS No 26761-40-0 and 68515-49-1

  • Einecs No 247-977-1 and 271-091-4

  • di-n-octyl phthalate (DNOP)

  • CAS No 117-84-0

  • Einecs No 204-214-7

Shall not be used as substances or as constituents of preparations, at concentrations higher than 0,1 % by mass of the plasticised material, in toys and childcare articles e which can be placed in the mouth by children.

Toys and childcare articles containing these phthalates in a concentration higher than 0,1 % by mass of the plasticised material shall not be placed on the market.

The Commission shall re-evaluate, by 16 January 2010 , the measures provided for in relation to this point in the light of new scientific information on such substances and their substitutes, and if justified, these measures shall be modified accordingly.

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