Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (Text with EEA relevance)
552/2009 • 32009R0552
Legal Acts - Regulations
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26.6.2009
EN
Official Journal of the European Union
L 164/7
COMMISSION REGULATION (EC) No 552/2009
of 22 June 2009
amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to 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 (1), and in particular Article 131 thereof,
Whereas:
(1)
Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (2) established in its Annex I restrictions for certain dangerous substances and preparations. Regulation (EC) No 1907/2006 repeals and replaces Directive 76/769/EEC with effect from 1 June 2009. Annex XVII to that Regulation replaces Annex I to Directive 76/769/EEC.
(2)
Article 67 of Regulation (EC) No 1907/2006 provides that substances, mixtures or articles may not be manufactured, placed on the market or used unless they comply with the conditions of any restrictions laid down in their regard in Annex XVII.
(3)
Directive 2006/122/EC of the European Parliament and of the Council of 12 December 2006 amending for the 30th time Council Directive 76/769/EEC (perfluorooctane sulfonates (PFOS)) (3) and Commission Directive 2006/139/EC of 20 December 2006 amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of arsenic compounds for the purpose of adapting its Annex I to technical progress (4) amending Annex I to Directive 76/769/EC were adopted shortly before Regulation (EC) No 1907/2006 was adopted, in December 2006, but the restrictions concerned have not yet been included in Annex XVII to that Regulation. Therefore Annex XVII should be amended to include the restrictions corresponding to Directives 2006/122/EC and 2006/139/EC as otherwise the restrictions concerned will be repealed on 1 June 2009.
(4)
Pursuant to Article 137(3) of Regulation (EC) No 1907/2006, any amendment to the restrictions adopted under Directive 76/769/EEC from 1 June 2007 is to be incorporated in Annex XVII to that Regulation with effect from 1 June 2009.
(5)
Directive 2007/51/EC of the European Parliament and of the Council amending Council Directive 76/769/EEC relating to restrictions on the marketing of certain measuring devices containing mercury (5) was adopted on 25 September 2007. Decision 1348/2008/EC of the European Parliament and Council amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of 2(2-methoxyethoxy)ethanol, 2-(2-butoxyethoxy)ethanol, methylenediphenyl diisocyanate, cyclohexane and ammonium nitrate (6) was adopted on 16 December 2008. The restrictions concerned have not yet been included in Annex XVII to that Regulation. Annex XVII should be amended to incorporate the restrictions on certain measuring devices containing mercury adopted under Directive 2007/51/EC and the restrictions on 2(2-methoxyethoxy)ethanol, 2-(2-butoxyethoxy)ethanol, methylene-diphenyl diisocyanate, cyclohexane and ammonium nitrate adopted under Decision 1348/2008/EC.
(6)
Account should be taken of the relevant provisions of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directive 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (7).
(7)
Since the provisions of Title VIII of Regulation (EC) No 1907/2006 and in particular Annex XVII are to be directly applicable from 1 June 2009, the restrictions should be clearly drafted in order to allow operators and enforcement authorities to apply them correctly. Therefore the drafting of the restrictions should be reviewed. The terminology for the different entries should be harmonised and made more coherent with the definitions contained in Regulation (EC) No 1907/2006.
(8)
Council Directive 96/59/EC of 16 September 1996 on the disposal of polychlorinated biphenyls and polychlorinated terphenyls (PCB/PCT) (8) requires that equipment containing PCBs and PCTs is decontaminated and disposed of as soon as possible and sets the conditions for the decontamination of equipment containing those substances. Therefore the entry in Annex XVII to Regulation (EC) 1907/2006 concerning PCTs should not include provision concerning equipment containing PCTs as that is fully regulated under Directive 96/59/EC.
(9)
The existing restrictions for the substances 2-naphthylamine, benzidine, 4-nitrobiphenyl, 4-aminobiphenyl are ambiguous as it is unclear whether the prohibition concerns only the supply to the general public or also the supply to professional users. These should be clarified. Since Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents (9) prohibits the production, manufacture and use at work of those substances, the restrictions in Annex XVII to Regulation (EC) No 1907/2006 relating to those substances should be consistent with Directive 98/24/EC.
(10)
The substances carbon tetrachloride and 1,1,1-trichloroethane are severely restricted under Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 June 2000 on substances that deplete the ozone layer (10). Regulation (EC) No 2037/2000 imposes for carbon tetrachloride a prohibition with exceptions, and for 1,1,1-trichloroethane a complete prohibition. Restrictions on carbon tetrachloride and 1,1,1-trichloroethane in Annex XVII to Regulation (EC) 1907/2006 are therefore superfluous and should be deleted.
(11)
Since mercury in batteries is regulated under Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators (11), the provisions on mercury in batteries currently contained in Annex XVII to Regulation (EC) No 1907/2006 are superfluous and should therefore be deleted.
(12)
Pursuant to Article 2(2) of Regulation (EC) No 1907/2006, waste is considered not to be a substance, a mixture, or an article within the meaning of Article 3 of Regulation (EC) No 1907/2006. Therefore since waste is not covered by the restrictions under that Regulation, provisions in Annex XVII thereto excluding waste are redundant and should be deleted.
(13)
Certain restrictions in Annex XVII to Regulation (EC) 1907/2006 should be modified in order to take into account the definitions of ‘use’ and ‘placing on the market’ contained in Article 3 of that Regulation.
(14)
The entry in Annex I to Directive 76/769/EEC concerning asbestos fibres included an exemption for diaphragms containing chrysotile. It should be specified that this exemption will be reviewed following receipt of reports that Member States who are making use of this exemption will have to submit. Moreover in the light of the definition of ‘placing on the market’ in Regulation (EC) No 1907/2006, Member States should be able to allow the placing on the market of some articles containing such fibres where the articles were already installed or in service before 1 January 2005, under specific conditions ensuring a high level of protection of human health
(15)
It should be made clear that, for substances which have been incorporated in Annex XVII to Regulation (EC) No 1907/2006 as a consequence of restrictions adopted in the framework of Directive 76/769/EEC (Entries 1 to 58), the restrictions do not apply to storage, keeping, treatment, filling into containers, or transfer from one container to another of the substances for export, unless the manufacture of the substances is prohibited.
(16)
Unlike Directive 76/769/EEC, Regulation (EC) No 1907/2006 defines the term ‘article’. In order to cover the same items as provided for in the original restriction on Cadmium, the term ‘mixtures’ should be added in some of the provisions.
(17)
It should be made clear that the restrictions incorporated in Annex XVII to Regulation (EC) No 1907/2006 on the marketing of certain measuring devices containing mercury do not apply to devices already in use in the Community at the time of entry into force of the restriction.
(18)
In the entries in Annex XVII to Regulation (EC) 1907/2006 for the substances diphenylether, pentabromo derivatives and diphenylether, octabromo derivatives, it should be provided that the restrictions do not apply to articles already in use at the date from which the restriction was to apply as those substances were incorporated in articles which have a long lifecycle and are sold on the second hand market, such as aeroplanes and vehicles. Moreover, since the use of the substances in electrical and electronic equipments is regulated under Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (12) that equipment should not be subject to the restrictions concerned.
(19)
It should be made clear in the restriction on nonylphenol and nonylphenol ethoxylate that the validity of existing national authorisations for pesticides and biocidal products containing nonylphenol ethoxylate as co-formulant should not be affected, as provided for in Article 1(2) of Directive 2003/53/EC of the European Parliament and of the Council of 18 June 2003 amending for the 26th time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (nonylphenol, nonylphenol ethoxylate and cement) (13).
(20)
It should be made clear that the restriction incorporated in Annex XVII to Regulation (EC) No 1907/2006 concerning perfluorooctane sulfonates does not apply to products which were already in use in the Community when the restriction entered into force.
(21)
The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,
HAS ADOPTED THIS REGULATION:
Article 1
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 June 2009.
For the Commission
Günter VERHEUGEN
Vice-President
(1) OJ L 396, 30.12.2006, p. 1.
(2) OJ L 262, 27.9.1976, p. 201.
(3) OJ L 372, 27.12.2006, p. 32.
(4) OJ L 384, 29.12.2006, p. 94.
(5) OJ L 257, 3.10.2007, p. 13.
(6) OJ L 348, 24.12.2008, p. 108.
(7) OJ L 353, 31.12.2008, p. 1.
(8) OJ L 243, 24.9.1996, p. 31.
(9) OJ L 131, 5.5.1998, p. 11.
(10) OJ L 244, 29.9.2000, p. 1.
(11) OJ L 266, 26.9.2006, p. 1.
(12) OJ L 37, 13.2.2003, p. 19.
(13) OJ L 178, 17.7.2003, p. 24.
ANNEX
Annex XVII to Regulation (EC) No 1907/2006 is amended as follows:
1.
the title is replaced by the following:
2.
the table setting out the designation of the substances, groups of substances and mixtures and the conditions of restriction is replaced by the following:
‘For substances which have been incorporated in this Annex as a consequence of restrictions adopted in the framework of Directive 76/769/EEC (Entries 1 to 58), the restrictions shall not apply to storage, keeping, treatment, filling into containers, or transfer from one container to another of these substances for export, unless the manufacture of the substances is prohibited.
Column 1
Designation of the substance, of the group of substances or of the mixture
Column 2
Conditions of restriction
1.
Polychlorinated terphenyls (PCTs)
Shall not be placed on the market, or used:
—
as substances,
—
in mixtures, including waste oils, or in equipment, in concentrations greater than 50 mg/kg (0,005 % by weight).
2.
Chloroethene (vinyl chloride)
CAS No 75-01-4
EC No 200-831-0
Shall not be used as propellant in aerosols for any use.
Aerosols dispensers containing the substance as propellant shall not be placed on the market.
3.
Liquid substances or mixtures, 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 articles, 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 article intended to be used as such, even with ornamental aspects.
2.
Articles not complying with paragraph 1 shall not be placed on the market.
3.
Shall not be placed on the market if they contain a colouring agent unless required for fiscal reasons or perfume or both and if they:
—
present an aspiration hazard and are labelled with R65 or H304, and,
—
can be used as fuel in decorative lamps, and,
—
are packaged in containers of a capacity of 15 litres or less.
4.
Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of substances and mixtures covered by paragraph 3, where intended for use in lamps, is marked visibly, 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
1.
Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.
2.
Articles not complying with paragraph 1 shall not be placed on the market.
5.
Benzene
CAS No 71-43-2
EC No 200-753-7
1.
Shall not be used in toys or parts of toys where the concentration of benzene in the free state is greater than 5 mg/kg (0,0005 %) of the weight of the toy or part of toy.
2.
Toys and parts of toys not complying with paragraph 1 shall not be placed on the market.
3.
Shall not be placed on the market, or used,
—
as a substance,
—
as a constituent of other substances, or in mixtures, in concentrations equal to, or greater than 0,1 % by weight.
4.
However, paragraph 3 shall not apply to:
(a)
motor fuels which are covered by Directive 98/70/EC;
(b)
substances and mixtures for use in industrial processes not allowing for the emission of benzene in quantities in excess of those laid down in existing legislation.
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
CAS No 12001-29-5
CAS No 132207-32-0
1.
The manufacture, placing on the market and use of these fibres and of articles containing these fibres added intentionally is prohibited.
However, Member States may exempt 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.
By 1 June 2011 Member States making use of this exemption shall provide a report to the Commission on the availability of asbestos free substitutes for electrolysis installations and the efforts undertaken to develop such alternatives, on the protection of the health of workers in the installations, on the source and quantities of chrysotile, on the source and quantities of diaphragms containing chrysotile, and the envisaged date of the end of the exemption. The Commission shall make this information publicly available.
Following receipt of those reports, the Commission shall request the Agency to prepare a dossier in accordance with Article 69 with a view to prohibit the placing on the market and use of diaphragms containing chrysotile.
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, restrict, prohibit or make subject to specific conditions, the use of such articles before they are disposed of or reach the end of their service life.
Member States may allow placing on the market of articles in their entirety containing asbestos fibres referred to in paragraph 1 which were already installed and/or in service before 1 January 2005, under specific conditions ensuring a high level of protection of human health. Member States shall communicate these national measures to the Commission by 1 June 2011. The Commission shall make this information publicly available.
3.
Without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances and mixtures, the placing on the market and use of articles containing these fibres, as permitted according to the preceding derogations, shall be permitted only if suppliers ensure before the placing on the market that articles bear a label in accordance with Appendix 7 to this Annex.
7.
Tris(aziridinyl)phosphinoxide
CAS No 545-55-1
EC No 208-892-5
1.
Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.
2.
Articles not complying with paragraph 1 shall not be placed on the market.
8.
Polybromobiphenyls; Polybrominatedbiphenyls (PBB)
CAS No 59536-65-1
1.
Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.
2.
Articles not complying with paragraph 1 shall not be placed on the market.
9.
(a)
Soap bark powder
(Quillaja saponaria) and its derivatives containing saponines
CAS No 68990-67-0
EC 273-620-4
(b)
Powder of the roots of Helleborus viridis and Helleborus niger
(c)
Powder of the roots of Veratrum album and Veratrum nigrum
(d)
Benzidine and/or its derivatives
CAS No 92-87-5
EC No 202-199-1
(e)
o-Nitrobenzaldehyde
CAS No 552-89-6
EC No 209-025-3
(f)
Wood powder
1.
Shall not be used, in jokes and hoaxes or in mixtures or articles intended to be used as such, for instance as a constituent of sneezing powder and stink bombs.
2.
Jokes and hoaxes, or mixtures or articles intended to be used as such, not complying with paragraph 1 shall not be placed on the market.
3.
However, paragraphs 1 and 2 shall not apply to stink bombs containing not more than 1,5 ml of liquid.
10.
(a)
Ammonium sulphide
CAS No 12135-76-1
EC No 235-223-4
(b)
Ammonium hydrogen sulphide
CAS No 12124-99-1
EC No 235-184-3
(c)
Ammonium polysulphide
CAS No 9080-17-5
EC No 232-989-1
1.
Shall not be used, in jokes and hoaxes or in mixtures or articles intended to be used as such, for instance as a constituent of sneezing powder and stink bombs.
2.
Jokes and hoaxes, or mixtures or articles intended to be used as such, not complying with paragraph 1 shall not be placed on the market.
3.
However, paragraphs 1 and 2 shall not apply to stink bombs containing not more than 1,5 ml of liquid.
11.
Volatile esters of bromoacetic acids:
(a)
Methyl bromoacetate
CAS No 96-32-2
EC No 202-499-2
(b)
Ethyl bromoacetate
CAS No 105-36-2
EC No 203-290-9
(c)
Propyl bromoacetate
CAS No 35223-80-4
(d)
Butyl bromoacetate
CAS No 18991-98-5
EC No 242-729-9
1.
Shall not be used, in jokes and hoaxes or in mixtures or articles intended to be used as such, for instance as a constituent of sneezing powder and stink bombs.
2.
Jokes and hoaxes, or mixtures or articles intended to be used as such, not complying with paragraph 1 shall not be placed on the market.
3.
However, paragraphs 1 and 2 shall not apply to stink bombs containing not more than 1,5 ml of liquid.
12.
2-Naphthylamine
CAS No 91-59-8
EC No 202-080-4 and its salts
13.
Benzidine
CAS No 92-87-5
EC No 202-199-1 and its salts
14.
4-Nitrobiphenyl
CAS No 92-93-3
Einecs EC No 202-204-7
15.
4-Aminobiphenyl xenylamine
CAS No 92-67-1
Einecs EC No 202-177-1 and its salts
The following shall apply to entries 12 to 15:
Shall not be placed on the market, or used, as substances or in mixtures in concentrations greater than 0,1 % by weight.
16.
Lead carbonates:
(a)
Neutral anhydrous carbonate (PbCO3)
CAS No 598-63-0
EC No 209-943-4
(b)
Trilead-bis(carbonate)-dihydroxide 2Pb CO3-Pb(OH)2
CAS No 1319-46-6
EC No 215-290-6
Shall not be placed on the market, or used, as substances or in mixtures, where the substance or mixture is intended for use as paint.
However, Member States may, in accordance with the provisions of International Labour Organisation (ILO) Convention 13 on the use of white lead and sulphates of lead in paint, permit the use on their territory of the substance or mixture for the restoration and maintenance of works of art and historic buildings and their interiors.
17.
Lead sulphates:
(a)
PbSO4
CAS No 7446-14-2
EC No 231-198-9
(b)
Pbx SO4
CAS No 15739-80-7
EC No 239-831-0
Shall not be placed on the market, or used, as substances or in mixtures, where the substance or mixture is intended for use as paint.
However, Member States may, in accordance with the provisions of ILO Convention 13 on the use of white lead and sulphates of lead in paint, permit the use on their territory of the substance or mixture for the restoration and maintenance of works of art and historic buildings and their interiors.
18.
Mercury compounds
Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is 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.
18a.
Mercury
CAS No 7439-97-6
EC No 231-106-7
1.
Shall not be placed on the market:
(a)
in fever thermometers;
(b)
in other measuring devices intended for sale to the general public (such as manometers, barometers, sphygmomanometers, thermometers other than fever thermometers).
2.
The restriction in paragraph 1 shall not apply to measuring devices that were in use in the Community before 3 April 2009. However Member States may restrict or prohibit the placing on the market of such measuring devices.
3.
The restriction in paragraph 1(b) shall not apply to:
(a)
measuring devices more than 50 years old on 3 October 2007;
(b)
barometers (except barometers within point (a)) until 3 October 2009.
4.
By 3 October 2009 the Commission shall carry out a review of the availability of reliable safer alternatives that are technically and economically feasible for mercury containing sphygmomanometers and other measuring devices in healthcare and in other professional and industrial uses. On the basis of this review or as soon as new information on reliable safer alternatives for sphygmomanometers and other measuring devices containing mercury becomes available, the Commission shall, if appropriate, present a legislative proposal to extend the restrictions in paragraph 1 to sphygmomanometers and other measuring devices in healthcare and in other professional and industrial uses, so that mercury in measuring devices is phased out whenever technically and economically feasible.
19.
Arsenic compounds
1.
Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use 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.
2.
Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use in the treatment of industrial waters, irrespective of their use.
3.
Shall not be used in the preservation of wood. Furthermore, wood so treated shall not be placed on the market.
4.
By way of derogation from paragraph 3:
(a)
Relating to the substances and mixtures for 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 and if they are authorised in accordance with Article 5(1) of Directive 98/8/EC. Wood so treated shall not be placed on the market before fixation of the preservative is completed.
(b)
Wood treated with CCA solution in accordance with point (a) 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, for example 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.
(c)
Without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that all treated wood placed on the market is 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”.
(d)
Treated wood referred to under point (a) 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 (b),
—
in any application where the treated wood may come into contact with intermediate or finished products intended for human and/or animal consumption.
5.
Wood treated with arsenic compounds that was in use in the Community before 30 September 2007, or that was placed on the market in accordance with paragraph 4 may remain in place and continue to be used until it reaches the end of its service life.
6.
Wood treated with CCA type C that was in use in the Community before 30 September 2007, or that was placed on the market in accordance with paragraph 4:
—
may be used or reused subject to the conditions pertaining to its use listed under points 4(b), (c) and (d),
—
may be placed on the market subject to the conditions pertaining to its use listed under points 4(b), (c) and (d).
7.
Member States may allow wood treated with other types of CCA solutions that was in use in the Community before 30 September 2007:
—
to be used or reused subject to the conditions pertaining to its use listed under points 4 (b), (c) and (d),
—
to be placed on the market subject to the conditions pertaining to its use listed under points 4(b), (c) and (d).
20.
Organostannic compounds
1.
Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is acting as biocide in free association paint.
2.
Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture acts as biocide 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 placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use in the treatment of industrial waters.
21.
Di-μ-oxo-di-n-butylstanniohydroxyborane/Dibutyltin hydrogen borate C8H19BO3Sn (DBB)
CAS No 75113-37-0
EC No 401-040-5
Shall not be placed on the market, or used, as a substance, or in mixtures in a concentration equal to, or greater than 0,1 % by weight.
However, the first paragraph shall not apply to this substance (DBB) or mixtures containing it if these are intended solely for conversion into 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
EC No 201-778-6 and its salts and esters
Shall not be placed on the market, or used,
—
as a substance,
—
as a constituent in other substances, or in mixtures, in a concentration equal to or greater than 0,1 % by weight.
23.
Cadmium
CAS No 7440-43-9
EC No 231-152-8 and its compounds
For the purpose of this entry, the codes and chapters indicated in square brackets are the codes and chapters of the tariff and statistical nomenclature of Common Customs Tariff as established by Council Regulation (EEC) No 2658/87 (1).
1.
Shall not be used to give colour to articles manufactured from the following substances and mixtures:
(a)
—
polyvinyl chloride (PVC) [3904 10] [3904 21] [3904 22]
—
polyurethane (PUR) [3909 50]
—
low-density polyethylene (ld PE), with the exception of low-density polyethylene used for the production of coloured masterbatch [3901 10]
—
cellulose acetate (CA) [3912 11] [3912 12]
—
cellulose acetate butyrate (CAB) [3912 11] [3912 12]
—
epoxy resins [3907 30]
—
melamine — formaldehyde (MF) resins [3909 20]
—
urea — formaldehyde (UF) resins [3909 10]
—
unsaturated polyesters (UP) [3907 91]
—
polyethylene terephthalate (PET) [3907 60]
—
polybutylene terephthalate (PBT)
—
transparent/general-purpose polystyrene [3903 11] [3903 19]
—
acrylonitrile methylmethacrylate (AMMA)
—
cross-linked polyethylene (VPE)
—
high-impact polystyrene
—
polypropylene (PP) [3902 10]
(b)
paints [3208] [3209]
However, if the paints have a high zinc content, their residual concentration of cadmium shall be as low as possible and shall in any event be less than 0,1 % by weight.
In any case, whatever their use or intended final purpose, articles or components of articles manufactured from the substances and mixtures listed above coloured with cadmium shall not be placed on the market if their cadmium content (expressed as Cd metal) is greater than 0,01 % by weight of the plastic material.
2.
However, paragraph 1 shall not apply to articles to be coloured for safety reasons.
3.
Shall not be used to stabilise the following mixtures or articles manufactured from polymers or copolymers of vinyl chloride:
—
packaging materials (bags, containers, bottles, lids) [3923 29 10],
—
office or school supplies [3926 10],
—
fittings for furniture, coachwork or the like [3926 30],
—
articles of apparel and clothing accessories (including gloves) [3926 20],
—
floor and wall coverings [3918 10],
—
impregnated, coated, covered or laminated textile fabrics [5903 10],
—
imitation leather [4202],
—
gramophone records,
—
tubes and pipes and their fittings [3917 23],
—
swing doors,
—
vehicles for road transport (interior, exterior, underbody),
—
coating of steel sheet used in construction or in industry,
—
insulation for electrical wiring.
In any case, whatever their use or intended final purpose, the placing on the market of the above mixtures, articles or components of articles manufactured from polymers or copolymers of vinyl chloride, stabilised by substances containing cadmium is prohibited, if their cadmium content (expressed as Cd metal) exceeds 0,01 % by weight of the polymer.
4.
However, paragraph 3 shall not apply to mixtures and articles using cadmium-based stabilisers for safety reasons.
5.
For the purpose of this entry, “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 following sectors/applications:
(a)
equipment and machinery for:
—
food production [8210] [8417 20] [8419 81] [8421 11] [8421 22] [8422] [8435] [8437] [8438] [8476 11]
—
agriculture [8419 31] [8424 81] [8432] [8433] [8434] [8436]
—
cooling and freezing [8418]
—
printing and book-binding [8440] [8442] [8443]
(b)
equipment and machinery for the production of:
—
household goods [7321] [8421 12] [8450] [8509] [8516]
—
furniture [8465] [8466] [9401] [9402] [9403] [9404]
—
sanitary ware [7324]
—
central heating and air conditioning plant [7322] [8403] [8404] [8415]
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 is prohibited.
6.
The provisions referred to in paragraph 5 shall also be 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] textiles and clothing [8444] [8445] [8447] [8448] [8449] [8451] [8452]
(b)
equipment and machinery for the production of:
—
industrial handling equipment and machinery [8425] [8426] [8427] [8428] [8429] [8430] [8431]
—
road and agricultural vehicles [chapter 87]
—
rolling stock [chapter 86]
—
vessels [chapter 89]
7.
However, the restrictions in paragraphs 5 and 6 shall 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, where that is necessary to ensure the reliability required of the apparatus on which they are installed.
24.
Monomethyl — tetrachlorodiphenyl methane
Trade name: Ugilec 141
CAS No 76253-60-6
1.
Shall not be placed on the market, or used, as a substance or in mixtures.
Articles containing the substance shall not be placed on the market.
2.
By way of derogation, 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;
(b)
in the case of the maintenance of plant and machinery already in service within a Member State on 18 June 1994.
For the purposes of point (a) 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.
25.
Monomethyl-dichloro-diphenyl methane
Trade name: Ugilec 121
Ugilec 21
Shall not be placed on the market, or used, as a substance or in mixtures.
Articles containing the substance shall not be placed on the market.
26.
Monomethyl-dibromo-diphenyl methane bromobenzylbromotoluene, mixture of isomers
Trade name: DBBT
CAS No 99688-47-8
Shall not be placed on the market, or used, as a substance or in mixtures.
Articles containing the substance shall not be placed on the market.
27.
Nickel
CAS No 7440-02-0
EC No 231-111-4 and its compounds
1.
Shall not be used:
(a)
in any 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/cm2/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/cm2/week.
(c)
in articles referred to 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/cm2/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 that paragraph.
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 Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as carcinogen category 1A or 1B (Table 3.1) or carcinogen category 1 or 2 (Table 3.2) and listed as follows:
—
Carcinogen category 1A (Table 3.1)/carcinogen category 1 (Table 3.2) listed in Appendix 1
—
Carcinogen category 1B (Table 3.1)/carcinogen category 2 (Table 3.2) listed in Appendix 2
29.
Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as germ cell mutagen category 1A or 1B (Table 3.1) or mutagen category 1 or 2 (Table 3.2) and listed as follows:
—
Mutagen category 1A (Table 3.1)/mutagen category 1 (Table 3.2) listed in Appendix 3
—
Mutagen category 1B (Table 3.1)/mutagen category 2 (Table 3.2) listed in Appendix 4
30.
Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as toxic to reproduction category 1A or 1B (Table 3.1) or toxic to reproduction category 1 or 2 (Table 3.2) and listed as follows:
—
Reproductive toxicant category 1A adverse effects on sexual function and fertility or on development (Table 3.1) or reproductive toxicant category 1 with R60 (May impair fertility) or R61 (May cause harm to the unborn child) (Table 3.2) listed in Appendix 5
—
Reproductive toxicant category 1B adverse effects on sexual function and fertility or on development (Table 3.1) or reproductive toxicant category 2 with R60 (May impair fertility) or R61 (May cause harm to the unborn child) (Table 3.2) listed in Appendix 6
Without prejudice to the other parts of this Annex the following shall apply to entries 28 to 30:
1.
Shall not be placed on the market, or used,
—
as substances,
—
as constituents of other substances, or,
—
in mixtures,
for supply to the general public when the individual concentration in the substance or mixture is equal to or greater than:
—
either the relevant specific concentration limit specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008, or,
—
the relevant concentration specified in Directive 1999/45/EC.
Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of such substances and mixtures is marked visibly, legibly and indelibly as follows:
“Restricted to professional users”.
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 Directive 76/768/EEC;
(c)
the following fuels and oil products:
—
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
EC No 232-287-5
(b)
Creosote oil; wash oil
CAS No 61789-28-4
EC No 263-047-8
(c)
Distillates (coal tar), naphthalene oils; naphthalene oil
CAS No 84650-04-4
EC No 283-484-8
(d)
Creosote oil, acenaphthene fraction; wash oil
CAS No 90640-84-9
EC No 283-484-8EC No 292-605-3
(e)
Distillates (coal tar), upper; heavy anthracene oil
CAS No 65996-91-0
EC No 266-026-1
(f)
Anthracene oil
CAS No 90640-80-5
EC No 292-602-7
(g)
Tar acids, coal, crude; crude phenols
CAS No 65996-85-2
EC No 266-019-3
(h)
Creosote, wood
CAS No 8021-39-4
EC No 232-419-1
(i)
Low temperature tar oil, alkaline; extract residues (coal), low temperature coal tar alkaline
CAS No 122384-78-5
EC No 310-191-5
1.
Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for the treatment of wood. Furthermore, wood so treated shall not be placed on the market.
2.
By way of derogation from paragraph 1:
(a)
The substances and mixtures 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 50 mg/kg (0,005 % by weight), and
(ii)
water extractable phenols at a concentration of less than 3 % by weight.
Such substances and mixtures 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 substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of such substances and mixtures is visibly, legibly and indelibly marked as follows:
“For use in industrial installations or professional treatment only”.
(b)
Wood treated in industrial installations or by professionals according to subparagraph (a) which is placed on the market for the first time or retreated in situ may be used for professional and industrial use only, for example on railways, in electric power transmission and telecommunications, for fencing, for agricultural purposes (for example 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.
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
EC No 200-663-8
34.
1,1,2-Trichloroethane
CAS No 79-00-5
EC No 201-166-9
35.
1,1,2,2-Tetrachloroethane
CAS No 79-34-5
EC No 201-197-8
36.
1,1,1,2-Tetrachloroethane
CAS No 630-20-6
37.
Pentachloroethane
CAS No 76-01-7
EC No 200-925-1
38.
1,1-Dichloroethene
CAS No 75-35-4
EC No 200-864-0
Without prejudice to the other parts of this Annex, the following shall apply to entries 32 to 38.
1.
Shall not be placed on the market, or used,
—
as substances,
—
as constituents of other substances, or in mixtures in concentrations equal to or greater than 0,1 % by weight,
where the substance or mixture is intended for supply to the general public and/or is intended for 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 substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of such substances and mixtures containing them in concentrations equal to or greater than 0,1 % by weight is visibly, legibly 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 Part 3 of Annex VI to Regulation (EC) No 1272/2008 or not.
1.
Shall not be used, as substance or as mixtures in aerosol dispensers where these aerosol dispensers are intended for supply to 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,
—
horns for parties,
—
decorative flakes and foams,
—
artificial cobwebs,
—
stink bombs.
2.
Without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances, suppliers shall ensure before the placing on the market that the packaging of aerosol dispensers referred to above is marked visibly, legibly and indelibly with:
“For professional users only”.
3.
By way of derogation, paragraphs 1 and 2 shall not apply to the aerosol dispensers referred to Article 8 (1a) of Council Directive 75/324/EEC (2).
4.
The aerosol dispensers 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
EC No 200-666-4
Shall not be placed on the market, or used, as substance or in mixtures, where the substance or mixture is intended for the manufacturing or processing of non-ferrous metals.
42.
Alkanes, C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs)
EC No 287-476-5
CAS No 85535-84-8
Shall not be placed on the market, or used as substances, or as constituents of other substances or in mixtures in concentrations greater than 1 % by weight, where the substance or mixture is intended for:
—
metalworking,
—
fat liquoring of leather.
43.
Azocolourants and Azodyes
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 mg/kg (0,003 % by weight) in the 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 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, as substances, or in mixtures in concentrations greater than 0,1 % by weight, where the substance or the mixture is intended for colouring textile and leather articles.
44.
Diphenylether, pentabromo derivative
C12H5Br5O
1.
Shall not be placed on the market, or used,
—
as a substance,
—
in mixtures in concentrations greater than 0,1 % by weight.
2.
Articles shall not be placed on the market if they, or flame-retarded parts thereof, contain this substance in concentrations greater than 0,1 % by weight.
3.
By way of derogation, paragraph 2 shall not apply
—
to articles that were in use in the Community before 15 August 2004,
—
to electrical and electronic equipment within the scope of Directive 2002/95/EC of the European Parliament and Council (3).
45.
Diphenylether, octabromo derivative
C12H2Br8O
1.
Shall not be placed on the market, or used:
—
as a substance,
—
as a constituent of other substances, or in mixtures, in concentrations greater than 0,1 % by weight.
2.
Articles shall not be placed on the market if they, or flame-retardant parts thereof, contain this substance in concentrations greater than 0,1 % by weight.
3.
By way of derogation, paragraph 2 shall not apply:
—
to articles that were in use in the Community before 15 August 2004,
—
to electrical and electronic equipment within the scope of Directive 2002/95/EC.
46.
(a)
Nonylphenol
C6H4(OH)C9H19
CAS 25154-52-3
EC 246-672-0
(b)
Nonylphenol ethoxylates
(C2H4O)nC15H24O
Shall not be placed on the market, or used, as substances or in mixtures in concentrations equal to or greater than 0,1 % by weight 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. However national authorisations for pesticides or biocidal products containing nonylphenol ethoxylates as co-formulant, granted before 17 July 2003, shall not be affected by this restriction until their date of expiry.
47.
Chromium VI compounds
1.
Cement and cement-containing mixtures shall not be placed on the market, or used, if they contain, when hydrated, more than 2 mg/kg (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 substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of cement or cement-containing mixtures is visibly, 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 mixtures are handled solely by machines and in which there is no possibility of contact with the skin.
48.
Toluene
CAS No 108-88-3
EC No 203-625-9
Shall not be placed on the market, or used, as a substance or in mixtures in a concentration equal to or greater than 0,1 % by weight where the substance or mixture is used in adhesives or spray paints intended for supply to the general public.
49.
Trichlorobenzene
CAS No 120-82-1
EC No 204-428-0
Shall not be placed on the market, or used, as a substance or in mixtures in a concentration equal to or greater than 0,1 % by weight for any use 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-triamino — 2,4,6-trinitrobenzene (TATB).
50.
Polycyclic-aromatic hydrocarbons (PAH)
(a)
Benzo[a]pyrene (BaP)
CAS No 50-32-8
(b)
Benzo[e]pyrene (BeP)
CAS No 192-97-2
(c)
Benzo[a]anthracene (BaA)
CAS No 56-55-3
(d)
Chrysen (CHR)
CAS No 218-01-9
(e)
Benzo[b]fluoranthene (BbFA)
CAS No 205-99-2
(f)
Benzo[j]fluoranthene (BjFA)
CAS No 205-82-3
(g)
Benzo[k]fluoranthene (BkFA)
CAS No 207-08-9
(h)
Dibenzo[a,h]anthracene (DBAhA)
CAS No 53-70-3
1.
From 1 January 2010, extender oils shall not be placed on the market, or used for the production of tyres or parts of tyres if they contain:
—
more than 1 mg/kg (0,0001 % by weight) BaP, or,
—
more than 10 mg/kg (0,001 % by weight) of the sum of all listed PAHs.
These limits shall be regarded as kept, if the polycyclic aromatics (PCA) extract is less than 3 % by weight 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, tyres and treads for retreading manufactured after 1 January 2010 shall not be placed on the market if they contain extender oils exceeding the limits indicated in paragraph 1.
These limits shall be 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.
For the purpose of this entry “tyres” shall mean tyres for vehicles covered by:
—
Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers (4),
—
Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units (5), and
—
Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles and repealing Council Directive 92/61/EEC (6).
51.
The following phthalates (or other CAS and EC numbers covering the substance):
(a)
Bis (2-ethylhexyl) phthalate (DEHP)
CAS No 117-81-7
EC No 204-211-0
(b)
Dibutyl phthalate (DBP)
CAS No 84-74-2
EC No 201-557-4
(c)
Benzyl butyl phthalate (BBP)
CAS No 85-68-7
EC No 201-622-7
1.
Shall not be used as substances or in mixtures, in concentrations greater than 0,1 % by weight of the plasticised material, in toys and childcare articles.
2.
Toys and childcare articles containing these phthalates in a concentration greater than 0,1 % by weight of the plasticised material shall not be placed on the market.
3.
The Commission shall re-evaluate, by 16 January 2010, the measures provided for in relation to this entry in the light of new scientific information on such substances and their substitutes, and if justified, these measures shall be modified accordingly.
4.
For the purpose of this entry “childcare article” shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.
52.
The following phthalates (or other CAS- and EC numbers covering the substance):
(a)
Di-“isononyl” phthalate (DINP)
CAS No 28553-12-0 and 68515-48-0
EC No 249-079-5 and 271-090-9
(b)
Di-“isodecyl” phthalate (DIDP)
CAS No 26761-40-0 and 68515-49-1
EC No 247-977-1 and 271-091-4
(c)
Di-n-octyl phthalate (DNOP)
CAS No 117-84-0
EC No 204-214-7
1.
Shall not be used as substances or in mixtures, in concentrations greater than 0,1 % by weight of the plasticised material, in toys and childcare articles which can be placed in the mouth by children.
2.
Such toys and childcare articles containing these phthalates in a concentration greater than 0,1 % by weight of the plasticised material shall not be placed on the market.
3.
The Commission shall re-evaluate, by 16 January 2010, the measures provided for in relation to this entry in the light of new scientific information on such substances and their substitutes, and if justified, these measures shall be modified accordingly.
4.
For the purpose of this entry “childcare article” shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.
53.
Perfluorooctane sulfonates (PFOS) C8F17SO2X
(X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers)
1.
Shall not be placed on the market, or used, as substances or in mixtures in concentrations equal to or greater than 50 mg/kg (0,005 % by weight).
2.
Shall not be placed on the market in semi-finished products or articles, or parts thereof, if the concentration of PFOS is equal to or greater than 0,1 % by weight calculated with reference to the mass of structurally or microstructurally distinct parts that contain PFOS or, for textiles or other coated materials, if the amount of PFOS is equal to or greater than 1 μg/m2 of the coated material.
3.
By way of derogation, paragraphs 1 and 2 shall not apply to the following items, nor to substances and mixtures needed to produce them:
(a)
photoresists or anti-reflective coatings for photolithography processes;
(b)
photographic coatings applied to films, papers, or printing plates;
(c)
mist suppressants for non-decorative hard chromium (VI) plating and wetting agents for use in controlled electroplating systems where the amount of PFOS released into the environment is minimised, by fully applying relevant best available techniques developed within the framework of Directive 2008/1/EC (7);
(d)
hydraulic fluids for aviation.
4.
By way of derogation from paragraph 1, fire-fighting foams that were placed on the market before 27 December 2006 may be used until 27 June 2011.
5.
By way of derogation, paragraph 2 shall not apply to articles that were in use in the Community before 27 June 2008.
6.
Paragraphs 1 and 2 shall apply without prejudice to Regulation (EC) No 648/2004 of the European Parliament and of the Council (8).
7.
As soon as new information on details of uses and safer alternative substances or technologies for the uses becomes available, the Commission shall review each of the derogations in paragraph 3(a) to (d) so that:
(a)
the uses of PFOS will be phased out as soon as the use of safer alternatives is technically and economically feasible;
(b)
a derogation can only be continued for essential uses for which safer alternatives do not exist and where the efforts undertaken to find safer alternatives have been reported on;
(c)
releases of PFOS into the environment have been minimised, by applying best available techniques.
8.
The Commission shall keep under review the ongoing risk assessment activities and the availability of safer alternative substances or technologies related to the uses of perfluorooctanoic acid (PFOA) and related substances and propose all necessary measures to reduce identified risks, including restrictions on marketing and use, in particular when safer alternative substances or technologies, that are technically and economically feasible, are available.
54.
2-(2-methoxyethoxy)ethanol (DEGME)
CAS No 111-77-3
EC No 203-906-6
Shall not be placed on the market after 27 June 2010, for supply to the general public, as a constituent of paints, paint strippers, cleaning agents, self-shining emulsions or floor sealants in concentrations equal to or greater than 0,1 % by weight.
55.
2-(2-butoxyethoxy)ethanol (DEGBE)
CAS No 112-34-5
EC No 203-961-6
1.
Shall not be placed on the market for the first time after 27 June 2010, for supply to the general public, as a constituent of spray paints or spray cleaners in aerosol dispensers in concentrations equal to or greater than 3 % by weight.
2.
Spray paints and spray cleaners in aerosol dispensers containing DEGBE and not conforming to paragraph 1 shall not be placed on the market for supply to the general public after 27 December 2010.
3.
Without prejudice to other Community legislation concerning the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that paints other than spray paints containing DEGBE in concentrations equal to or greater than 3 % by weight of that are placed on the market for supply to the general public are visibly, legibly and indelibly marked by 27 December 2010 as follows:
“Do not use in paint spraying equipment”.
56.
Methylenediphenyl diisocyanate (MDI)
CAS No 26447-40-5
EC No 247-714-0
1.
Shall not be placed on the market after 27 December 2010, as a constituent of mixtures in concentrations equal to or greater than 0,1 % by weight of MDI for supply to the general public, unless suppliers shall ensure before the placing on the market that the packaging:
(a)
contains protective gloves which comply with the requirements of Council Directive 89/686/EEC (9);
(b)
is marked visibly, legibly and indelibly as follows, and without prejudice to other Community legislation concerning the classification, packaging and labelling of substances and mixtures:
“—
Persons already sensitised to diisocyanates may develop allergic reactions when using this product.
—
Persons suffering from asthma, eczema or skin problems should avoid contact, including dermal contact, with this product.
—
This product should not be used under conditions of poor ventilation unless a protective mask with an appropriate gas filter (i.e. type A1 according to standard EN 14387) is used.”
2.
By way of derogation, paragraph 1(a) shall not apply to hot melt adhesives.
57.
Cyclohexane
CAS No 110-82-7
EC No 203-806-2
1.
Shall not be placed on the market for the first time after 27 June 2010, for supply to the general public, as a constituent of neoprene-based contact adhesives in concentrations equal to or greater than 0,1 % by weight in package sizes greater than 350 g.
2.
Neoprene-based contact adhesives containing cyclohexane and not conforming to paragraph 1 shall not be placed on the market for supply to the general public after 27 December 2010.
3.
Without prejudice to other Community legislation concerning the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that neoprene-based contact adhesives containing cyclohexane in concentrations equal to or greater than 0,1 % by weight that are placed on the market for supply to the general public after 27 December 2010 are visibly, legibly and indelibly marked as follows:
“—
This product is not to be used under conditions of poor ventilation.
—
This product is not to be used for carpet laying.”.
58.
Ammonium nitrate (AN)
CAS No 6484-52-2
EC No 229-347-8
1.
Shall not be placed on the market for the first time after 27 June 2010 as a substance, or in mixtures that contain more than 28 % by weight of nitrogen in relation to ammonium nitrate, for use as a solid fertiliser, straight or compound, unless the fertiliser complies with the technical provisions for ammonium nitrate fertilisers of high nitrogen content set out in Annex III to Regulation (EC) No 2003/2003 of the European Parliament and of the Council (10).
2.
Shall not be placed on the market after 27 June 2010 as a substance, or in mixtures that contain 16 % or more by weight of nitrogen in relation to ammonium nitrate except for supply to:
(a)
downstream users and distributors, including natural or legal persons licensed or authorised in accordance with Council Directive 93/15/EEC (11);
(b)
farmers for use in agricultural activities, either full time or part time and not necessarily related to the size of the land area.
For the purposes of this subparagraph:
(i)
“farmer” shall mean a natural or legal person, or a group of natural or legal persons, whatever legal status is granted to the group and its members by national law, whose holding is situated within Community territory, as referred to in Article 299 of the Treaty, and who exercises an agricultural activity;
(ii)
“agricultural activity” shall mean the production, rearing or growing of agricultural products including harvesting, milking, breeding animals and keeping animals for farming purposes, or maintaining the land in good agricultural and environmental condition as established under Article 5 of Council Regulation (EC) No 1782/2003 (12);
(c)
natural or legal persons engaged in professional activities such as horticulture, plant growing in greenhouses, maintenance of parks, gardens or sport pitches, forestry or other similar activities.
3.
However, for the restrictions in paragraph 2, Member States may until 1 July 2014, for socioeconomic reasons, apply a limit of up to 20 % by weight of nitrogen in relation to ammonium nitrate for substances and mixtures placed on the market within their territories. They shall inform the Commission and other Member States thereof.
3.
in the Appendices 1 to 6, the foreword is replaced by the following:
‘FOREWORD
Explanations of column headings
Substances:
The name corresponds to the International Chemical Identification used for the substance in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
Whenever possible, substances are designated by their IUPAC names. Substances listed in Einecvs (European Inventory of Existing Commercial Chemical Substances), Elincs (European List of Notified Substances) or the list of “No-longer-polymers” are designated using the names in these lists. Other names, such as usual or common names, are included in some cases. Whenever possible, plant protection products and biocides are designated by their ISO names.
Entries for groups of substances:
A number of group entries are included in Part 3 of Annex VI to Regulation (EC) No 1272/2008. In these cases, the classification requirements will apply to all substances covered by the description.
In some cases, there are classification requirements for specific substances that would be covered by the group entry. In such cases a specific entry is included in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance and the group entry will be annotated with the phrase “except those specified elsewhere in Annex VI to Regulation (EC) No 1272/2008”.
In some cases, individual substances may be covered by more than one group entry. In these cases, the classification of the substance reflects the classification for each of the two group entries. In cases where different classifications for the same hazard are given, the most severe classification will be applied.
Index number:
The Index number is the identification code given to the substance in Part 3 of Annex VI to Regulation (EC) No 1272/2008. Substances are listed in the Appendix according to this index number.
EC numbers:
The EC number, i.e. Einecs, Elincs or NLP, is the official number of the substance within the European Union. The Einecs number can be obtained from the European Inventory of Existing Commercial Chemical Substance (Einecs). The Elincs number can be obtained from the European List of Notified Substances. The NLP number can be obtained from the list of “No-longer-polymers”. These lists are published by the Office for Official Publications of the European Communities.
The EC number is a seven-digit system of the type XXX-XXX-X which starts at 200-001-8 (Einecs), at 400-010-9 (Elincs) and at 500-001-0 (NLP). This number is indicated in the column entitled “EC No”.
CAS number:
Chemical Abstracts Service (CAS) numbers have been defined for substances to help in their identification.
Notes:
The full text of the notes can be found in Part 1 of Annex VI to Regulation (EC) No 1272/2008.
The notes to be taken into account for the purposes of this Regulation are the following:
Note A:
Without prejudice to Article 17(2) of Regulation (EC) No 1272/2008, the name of the substance must appear on the label in the form of one of the designations given in Part 3 of Annex VI to that Regulation.
In that Part, use is sometimes made of a general description such as “… compounds” or “… salts”. In this case, the supplier who places such a substance on the market is required to state on the label the correct name, due account being taken of Section 1.1.1.4 of Annex VI to Regulation (EC) No 1272/2008.
Note C:
Some organic substances may be marketed either in a specific isomeric form or as a mixture of several isomers.
Note D:
Certain substances which are susceptible to spontaneous polymerisation or decomposition are generally placed on the market in a stabilised form. It is in this form that they are listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008.
However, such substances are sometimes placed on the market in a non-stabilised form. In this case, supplier who places such a substance on the market must state on the label the name of the substance followed by the words “non-stabilised”.
Note J:
The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (EC No 200-753-7).
Note K:
The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3-butadiene (EC No 203-450-8).
Note L:
The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3 % DMSO extract as measured by IP 346.
Note M:
The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,005 % w/w benzo[a]-pyrene (EC No 200-028-5).
Note N:
The classification as a carcinogen need not apply if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen.
Note P:
The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (EC No 200-753-7).
Note R:
The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter, less two standard errors, greater than 6μm.’;
4.
in Appendices 1, 2, 3, 5 and 6, in the entries, in the column headed ‘notes’, references to notes E, H and S are deleted;
5.
in Appendix 1, the heading is replaced by ‘Entry 28 — Carcinogens: category 1A (Table 3.1)/category 1 (Table 3.2)’;
6.
Appendix 2 shall be amended as follows:
(a)
the heading is replaced by ‘Entry 28 — Carcinogens: category 1B (Table 3.1)/category 2 (Table 3.2)’;
(b)
in the entries index Nos 024-017-00-8, 611-024-00-1, 611-029-00-9, 611-030-00-4 and 650-017-00-8, the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Annex VI to Regulation (EC) No 1272/2008’;
(c)
the entries with index numbers 649-062-00-6, 649-063-00-1, 649-064-00-7, 649-065-00-2, 649-066-00-8, 649-067-00-3, 649-068-00-9, 649-069-00-4, 649-070-00-X, 649-071-00-5, 649-072-00-0, 649-073-00-6, 649-074-00-1, 649-075-00-7, 649-076-00-2, 649-077-00-8, 649-078-00-3, 649-079-00-9, 649-080-00-4, 649-081-00-X, 649-082-00-5, 649-083-00-0, 649-084-00-6, 649-085-00-1, 649-086-00-7, 649-087-00-2, 649-089-00-3, 649-090-00-9, 649-091-00-4, 649-092-00-X, 649-093-00-5, 649-094-00-0, 649-095-00-6, 649-096-00-1, 649-097-00-7, 649-098-00-2, 649-099-00-8, 649-100-00-1, 649-101-00-7, 649-102-00-2, 649-103-00-8, 649-104-00-3, 649-105-00-9, 649-106-00-4, 649-107-00-X, 649-108-00-5, 649-109-00-0, 649-110-00-6, 649-111-00-1, 649-112-00-7, 649-113-00-2, 649-114-00-8, 649-115-00-3, 649-116-00-9, 649-117-00-4, 649-119-00-5, 649-120-00-0, 649-121-00-6, 649-122-00-1, 649-123-00-7, 649-124-00-2, 649-125-00-8, 649-126-00-3, 649-127-00-9, 649-128-00-4, 649-129-00-X, 649-130-00-5, 649-131-00-0, 649-132-00-6, 649-133-00-1, 649-134-00-7, 649-135-00-2, 649-136-00-8, 649-137-00-3, 649-138-00-9, 649-139-00-4, 649-140-00-X, 649-141-00-5, 649-142-00-0, 649-143-00-6, 649-144-00-1, 649-145-00-7, 649-146-00-2, 649-147-00-8, 649-148-00-3, 649-149-00-9, 649-150-00-4, 649-151-0-X, 649-152-00-5, 649-153-00-0, 649-154-00-6, 649-155-00-1, 649-156-00-7, 649-157-00-2, 649-158-00-8, 649-159-00-3, 649-160-00-9, 649-161-00-4, 649-162-00-X, 649-163-00-5, 649-164-00-0, 649-165-00-6, 649-166-00-1, 649-167-00-7, 649-168-00-2, 649-169-00-8, 649-170-00-3, 649-171-00-9, 649-172-00-4, 649-173-00-X, 649-174-00-5, 649-177-00-1, 649-178-00-7, 649-179-00-2, 649-180-00-8, 649-181-00-3, 649-182-00-9, 649-183-00-4, 649-184-00-X, 649-185-00-5, 649-186-00-0, 649-187-00-6, 649-188-00-1, 649-189-00-7, 649-190-00-2, 649-191-00-8, 649-193-00-9, 649-194-00-4, 649-195-00-X, 649-196-00-5, 649-197-00-0, 649-198-00-6, 649-199-00-1, 649-200-00-5, 649-201-00-0, 649-202-00-6, 649-203-00-1, 649-204-00-7, 649-205-00-2, 649-206-00-8, 649-207-00-3, 649-208-00-9, 649-209-00-4 and 649-210-00-X are deleted;
7.
in Appendix 3, the heading is replaced by ‘Entry 29 — Mutagens: category 1A (Table 3.1)/category 1 (Table 3.2)’;
8.
in Appendix 4, the heading is replaced by ‘Entry 29 — Mutagens: category 1B (Table 3.1)/category 2 (Table 3.2)’;
9.
in Appendix 5, the heading is replaced by ‘Entry 30 — Toxic to reproduction: category 1A (Table 3.1)/category 1 (Table 3.2)’;
10.
in Appendix 6, the heading is replaced by ‘Entry 30 — Toxic to reproduction: category 1B (Table 3.1)/category 2 (Table 3.2)’;
11.
in Appendix 8, the heading is replaced by ‘Entry 43 — Azocolourants — List of aromatic amines’;
12.
In Appendix 9, the heading is replaced by ‘Entry 43 — Azocolourants — List of azodyes’;
13.
Appendix 10 shall be amended as follows:
(a)
the heading is replaced by ‘Entry 43 — Azocolourants — List of testing methods’;
(b)
in the footnote, the addresses of CEN and Cenelec are replaced by the following:
‘CEN: Avenue Marnix 17, 1000 Brussels, Belgium, tel. +32 2550 08 11, fax +32 2550 08 19 (http://www.cen.eu/cenorm/homepage.htm)
Cenelec: Avenue Marnix 17, B-1000 Brussels, tel. +32 25196871, fax +32 2519 69 19 (http://www.cenelec.eu/Cenelec/Homepage.htm)’
(1) OJ L 256, 7.9.1987, p. 42.
(2) OJ L 147, 9.6.1975, p. 40.
(3) OJ L 37, 13.2.2003, p. 19.
(4) OJ L 263, 9.10.2007, p. 1.
(5) OJ L 171, 9.7.2003, p. 1.
(6) OJ L 124, 9.5.2002, p. 1.
(7) OJ L 24, 29.1.2008, p. 8.
(8) OJ L 104, 8.4.2004, p. 1.
(9) OJ L 399, 30.12.1989, p. 18.
(10) OJ L 304, 21.11.2003, p. 1.
(11) OJ L 121, 15.5.1993, p. 20.
(12) OJ L 270, 21.10.2003, p. 1.’