Entry 21

Di-μ-oxo-di-n-butylstanniohydroxyborane/Dibutyltin hydrogen borate
C8H19BO3Sn (DBB)
ジ-μ-オキソ-ジ-n-ブチルスタンイオヒドロキシボラン/ ジブチルスズホウ酸塩（DBB)

 

CAS No 75113-37-0, EC No 401-040-5

 

Conditions of restriction

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 %.

 

Entry 22は削除（2020.12.16)

Entry 22（削除）

Pentachlorophenol and its salts and esters
ペンタクロロフェノールおよびその塩、エステル

 

CAS No 87-86-5, EC No 201-778-6

 

Conditions of restriction

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.

 

Entry 23

Cadmium and its compounds
カドミウムおよびその化合物

 

CAS No 7440-43-9, EC No 231-152-8

 

Conditions of restriction

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. Shall not be used in mixtures and articles produced from the following synthetic organic polymers (hereafter referred to as plastic material):
— polymers or copolymers of vinyl chloride (PVC) [3904 10] [3904 21]
— polyurethane (PUR) [3909 50]
— low-density polyethylene (LDPE), with the exception of low-density polyethylene used for the production of coloured masterbatch [3901 10]
— cellulose acetate (CA) [3912 11]
— cellulose acetate butyrate (CAB) [3912 11]
— 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]
— acrylonitrile methylmethacrylate (AMMA)
— cross-linked polyethylene (VPE)
— high-impact polystyrene
— polypropylene (PP) [3902 10]

 

Mixtures and articles produced from plastic material as listed above shall not be placed on the market if the concentration of cadmium (expressed as Cd metal) is equal to or greater than 0,01 % by weight of the plastic material.

 

By way of derogation, the second subparagraph shall not apply to articles placed on the market before 10 December 2011.
The first and second subparagraphs apply without prejudice to Council Directive 94/62/ EC (**) and acts adopted on its basis.
By 19 November 2012, in accordance with Article 69, the Commission shall ask the European Chemicals Agency to prepare a dossier conforming to the requirements of Annex XV in order to assess whether the use of cadmium and its compounds in plastic material, other than that listed in subparagraph 1, should be restricted.

 

2. Shall not be used or placed on the market in paints with codes [3208] [3209] in a concentration (expressed as Cd metal) equal to or greater than 0,01 % by weight.
For paints with codes [3208] [3209] with a zinc content exceeding 10 % by weight of the paint, the concentration of cadmium (expressed as Cd metal) shall not be equal to or greater than 0,1 % by weight.
Painted articles shall not be placed on the market if the concentration of cadmium (expressed as Cd metal) is equal to or greater than 0,1 % by weight of the paint on the painted article.

 

3. By way of derogation, paragraphs 1 and 2 shall not apply to articles coloured with mixtures containing cadmium for safety reasons.

 

4. By way of derogation, paragraph 1, second sub paragraph shall not apply to:
— mixtures produced from PVC waste, hereinafter referred to as ‘recovered PVC’,
— mixtures and articles containing recovered PVC if their concentration of cadmium (expressed as Cd metal) does not exceed 0,1 % by weight of the plastic material in the following rigid PVC applications:
(a) profiles and rigid sheets for building applications;
(b) doors, windows, shutters, walls, blinds, fences, and roof gutters;
(c) decks and terraces;
(d) cable ducts;
(e) pipes for non-drinking water if the recovered PVC is used in the middle layer of a multilayer pipe and is entirely covered with a layer of newly produced PVC in compliance with paragraph 1 above.

 

Suppliers shall ensure, before the placing on the market of mixtures and articles containing recovered PVC for the first time, that these are visibly, legibly and indelibly marked as follows: ‘ Contains recovered PVC ’ or with the following pictogram:

 

In accordance with Article 69 of this Regulation, the derogation granted in paragraph 4 will be reviewed, in particular with a view to reducing the limit value for cadmium and to reassess the derogation for the applications listed in points (a) to (e), by 31 December 2017.

 

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.

 

8. Shall not be used in brazing fillers in concentration equal to or greater than 0,01 % by weight.
Brazing fillers shall not be placed on the market if the concentration of cadmium (expressed as Cd metal) is equal to or greater than 0,01 % by weight.
For the purpose of this paragraph brazing shall mean a joining technique using alloys and undertaken at temperatures above 450 °C.

 

9. By way of derogation, paragraph 8 shall not apply to brazing fillers used in defence and aerospace applications and to brazing fillers used for safety reasons.

 

10. Shall not be used or placed on the market if the concentration is equal to or greater than 0,01 % by weight of the metal in:

 

(i) metal beads and other metal components for jewellery making;
(ii) metal parts of jewellery and imitation jewellery articles and hair accessories,including:
— bracelets, necklaces and rings,
— piercing jewellery,
— wrist-watches and wrist-wear,
— brooches and cufflinks.

 

11. By way of derogation, paragraph 10 shall not apply to articles placed on the market before 10 December 2011 and jewellery more than 50 years old on 10 December 2011.
(*) OJ L 256, 7.9.1987, p. 42.
(**) OJ L 365, 31.12.1994, p. 10

 

Entry 24

Monomethyl — tetrachlorodiphenyl methane
Trade name: Ugilec 141
モノメチル-テトラクロロジフェニルメタン
(商品名：Ugilec 141)

 

CAS No 76253-60-6

 

Conditions of restriction

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.

 

Entry 25

Monomethyl-dichloro-diphenyl methane
Trade name: Ugilec 121, Ugilec 21
モノメチル-ジクロロ-ジフェニルメタン
(商品名：Ugilec 121, Ugilec 21）

 

Conditions of restriction

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.

 

Entry 26

Monomethyl-dibromo-diphenyl methane bromobenzylbromotoluene, mixture of isomers
Trade name: DBBT
モノメチル-ジブロモ-ジフェニルメタン ブロモベンジルブロモトルエン異性体混合物（DBBT)

 

CAS No 99688-47-8

 

Conditions of restriction

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.

 

Entry 27

Nickel and its compounds
ニッケルおよびその化合物

 

CAS No 7440-02-0, EC No 231-111-4

 

Conditions of restriction

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.

 

Entry 28

Substances which are classified as carcinogen category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 1 or Appendix 2, respectively.

 

Conditions of restriction

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 generic concentration limit specified in Part 3 of Annex I of Regulation (EC) No 1272/2008.

 

 

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 Regulation (EC) No 1272/2008;
(e) the substances listed in Appendix 11, column 1, for the applications or uses listed in Appendix 11, column 2. Where a date is specified in column 2 of Appendix 11, the derogation shall apply until the said date.
(f) devices covered by Regulation (EU) 2017/745　（2020.12.16追加）

 

Entry 29

Substances which are classified as germ cell mutagen category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 3 or Appendix 4,
respectively.

 

Conditions of restriction

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 generic concentration limit specified in Part 3 of Annex I of Regulation (EC) No 1272/2008.

 

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 Regulation (EC) No 1272/2008;
(e) the substances listed in Appendix 11, column 1, for the applications or uses listed in Appendix 11, column 2. Where a date is specified in column 2 of Appendix 11, the derogation shall apply until the said date.
(f) devices covered by Regulation (EU) 2017/745　（2020.12.16追加）

Entry 30

Substances which are classified as reproductive toxicant category 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendix 5 or Appendix 6,respectively.

Conditions of restriction

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 generic concentration limit specified in Part 3 of Annex I of  Regulation (EC) No 1272/2008.

 

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 Regulation (EC) No 1272/2008;
(e) the substances listed in Appendix 11, column 1, for the applications or  uses listed in Appendix 11, column 2. Where a date is specified in column 2 of  Appendix 11, the derogation shall apply until the said date.
(f) devices covered by Regulation (EU) 2017/745　（2020.12.16追加）