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制限条件(英文)Entry 61-70

Entry 61

Dimethylfumarate (DMF)
 CAS No 624-49-7,EC No 210-849-0

 

Conditions of restriction

Shall not be used in articles or any parts thereof in concentrations greater than 0,1 mg/kg.

 

Articles or any parts thereof containing DMF in concentrations greater than 0,1 mg/kg shall not be placed on the market.

 

Entry 62

(a) Phenylmercury acetate
 CAS No 62-38-4, EC No 200-532-5
(b) Phenylmercury propionate
 CAS No 103-27-5, EC No 203-094-3
(c) Phenylmercury 2-ethylhexanoate
 CAS No 13302-00-6, EC No 236-326-7
(d) Phenylmercury octanoate
 CAS No 13864-38-5
(e) Phenylmercury neodecanoate
 CAS No 26545-49-3, EC No 247-783-7

 

Conditions of restriction

1.Shall not be manufactured, placed on the market or used as substances or in mixtures after 10 October 2017 if the concentration of mercury in the mixtures is equal to or greater than 0,01 % by weight.

 

2. Articles or any parts thereof containing one or more of these substances shall not be placed on the market after 10 October 2017 if the concentration of mercury in the articles or any part thereof is equal to or greater than 0,01 % by weight.

 

Entry 63

Lead and its compounds
 CAS No 7439-92-1, EC No 231-100-4

 

Conditions of restriction

1. Shall not be placed on the market or used in any individual part of jewellery articles if the concentration of lead (expressed as metal) in such a part is equal to or greater than 0,05 % by weight.

 

2. For the purposes of paragraph 1:
(i) ‘jewellery articles’ shall include jewellery and imitation jewellery articles and hair accessories, including:
 (a) bracelets, necklaces and rings;
 (b) piercing jewellery;
 (c) wrist watches and wrist-wear;
 (d) brooches and cufflinks;

 

(ii) ‘any individual part’ shall include the materials from which the jewellery is made,
as well as the individual components of the jewellery articles.

 

3. Paragraph 1 shall also apply to individual parts when placed on the market or used for jewellery-making.

 

4. By way of derogation, paragraph 1 shall not apply to:
(a) crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Council Directive 69/493/EEC(*);
(b) internal components of watch timepieces inaccessible to consumers;
(c) non-synthetic or reconstructed precious and semiprecious stones (CN code 7103, as established by Regulation (EEC) No 2658/87), unless they have been treated with lead or its compounds or mixtures containing these substances;
(d) enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of minerals melted at a temperature of at least 500 °C.

 

5. By way of derogation, paragraph 1 shall not apply to jewellery articles placed on the market for the first time before 9 October 2013 and jewellery articles produced before 10 December 1961.

 

6. By 9 October 2017, the Commission shall re-evaluate this entry in the light of new scientific information, including the availability of alternatives and the migration of lead from the articles referred to in paragraph 1 and, if appropriate, modify this entry accordingly.

 

7. Shall not be placed on the market or used in articles supplied to the general public, if the concentration of lead (expressed as metal) in those articles or accessible parts thereof is equal to or greater than 0,05 % by weight, and those articles or accessible parts thereof may, during normal or reasonably foreseeable conditions of use, be placed in the mouth by children.

 

That limit shall not apply where it can be demonstrated that the rate of lead release from such an article or any such accessible part of an article, whether coated or uncoated, does not exceed 0,05 μg/cm² per hour (equivalent to 0,05 μg/g/h), and, for coated articles, that the coating is sufficient to ensure that this release rate is not exceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of the article.

 

For the purposes of this paragraph, it is considered that an article or accessible part of an article may be placed in the mouth by children if it is smaller than 5 cm in one dimension or has a detachable or protruding part of that size.

 

8. By way of derogation, paragraph 7 shall not apply to:
(a) jewellery articles covered by paragraph 1;
(b) crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Directive 69/493/EEC;
(c) non-synthetic or reconstructed precious and semi-precious stones (CN code 7103 as established by Regulation (EEC) No 2658/ 87) unless they have been treated with lead or its compounds or mixtures containing these substances;
(d) enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of mineral melted at a temperature of at least 500 ° C;
(e) keys and locks, including padlocks;
(f) musical instruments;
(g) articles and parts of articles comprising brass alloys, if the concentration of lead
(expressed as metal) in the brass alloy does not exceed 0,5 % by weight;
(h) the tips of writing instruments;
(i) religious articles;
(j) portable zinc-carbon batteries and button cell batteries;
(k) articles within the scope of:
 (i) Directive 94/62/EC;
 (ii) Regulation (EC) No 1935/2004;
 (iii) Directive 2009/48/EC of the European Parliament and of the Council (**);
 (iv) Directive 2011/65/EU of the European Parliament and of the Council (***)

 

9.By 1 July 2019, the Commission shall re-evaluate paragraphs 7 and 8(e), (f), (i) and (j) of this entry in the light of new scientific information, including the availability of alternatives and the migration of lead from the articles referred to in paragraph 7, including the requirement on coating integrity, and, if appropriate, modify this entry accordingly.

 

10. By way of derogation paragraph 7 shall not apply to articles placed on the market for the first time before 1 June 2016.

 

(*) OJ L 326, 29.12.1969, p. 36.
(**) Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1).
(***) Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88).

 

Entry 64

1,4-dichlorobenzene
 CAS No 106-46-7, EC No 203-400-5

 

Conditions of restriction

Shall not be placed on the market or used, as a substance or as a constituent of mixtures in a concentration equal to or greater than 1 % by weight, where the substance or the mixture is placed on the market for use or used as an air freshener or deodoriser in toilets, homes, offices or other indoor public areas

 

Entry 65

Inorganic ammonium salts

 

Conditions of restriction

1. Shall not be placed on the market, or used, in cellulose insulation mixtures or cellulose insulation articles after 14 July 2018 unless the emission of ammonia from those mixtures or articles results in a concentration of less than 3 ppm by volume (2,12 mg/m3) under the test conditions specified in paragraph 4.

 

A supplier of a cellulose insulation mixture containing inorganic ammonium salts shall inform the recipient or consumer of the maximum permissible loading rate of the cellulose insulation mixture, expressed in thickness and density.

 

A downstream user of a cellulose insulation mixture containing inorganic ammonium salts shall ensure that the maximum permissible loading rate communicated by the supplier is not exceeded.

 

2. By way of derogation, paragraph 1 shall not apply to placing on the market of cellulose insulation mixtures intended to be used solely for the production of cellulose insulation articles, or to the use of those mixtures in the production of cellulose insulation articles.

 

3. In the case of a Member State that, on 14 July 2016, has national provisional measures in place that have been authorised by the Commission pursuant to Article 129(2)(a), the provisions of paragraphs 1 and 2 shall apply from that date.

 

4. Compliance with the emission limit specified in the first subparagraph of paragraph 1 shall be demonstrated in accordance with Technical Specification CEN/TS 16516, adapted as follows:
(a) the duration of the test shall be at least 14 days instead of 28 days;
(b) the ammonia gas emission shall be measured at least once per day throughout the test;
(c) the emission limit shall not be reached or exceeded in any measurement taken during the test;
(d) the relative humidity shall be 90 % instead of 50 %;
(e) an appropriate method to measure the ammonia gas emission shall be used;
(f) the loading rate, expressed in thickness and density, shall be recorded during the sampling of the cellulose insulation mixtures or articles to be tested.’

 

Entry 66

Bisphenol A
 CAS No 80-05-7, EC No 201-245-8

 

Conditions of restriction

Shall not be placed on the market in thermal paper in a concentration equal to or greater than 0,02 % by weight after 2 January 2020.

 

Entry 67

Bis(pentabromophenyl)ether (decabromodiphenyl ether; decaBDE)
 CAS No 1163-19-5, EC No 214-604-9

 

Conditions of restriction

1. Shall not be manufactured or placed on the market as a substance on its own after 2 March 2019.

 

2. Shall not be used in the production of, or placed on the market in:
(a) another substance, as a constituent;
(b) a mixture;
(c) an article, or any part thereof, in a concentration equal to or greater than 0,1 % by weight, after 2 March 2019.

 

3. Paragraphs 1 and 2 shall not apply to a substance, constituent of another substance or mixture that is to be used, or is used:
(a) in the production of an aircraft before 2 March 2027.
(b) in the production of spare parts for either of the following:
(i) an aircraft produced before 2 March 2027;
(ii) motor vehicles within the scope of Directive 2007/46/EC, agricultural and forestry vehicles within the scope of Regulation (EU) No 167/2013 of the European Parliament and of the Council1 or machinery within the scope of Directive 2006/42/EC of the European Parliament and of the Council2, produced before 2 March 2019.

 

4. Subparagraph 2(c) shall not apply to any of the following:
(a) articles placed on the market before 2 March 2019;
(b) aircraft produced in accordance with subparagraph 3(a);
(c) spare parts of aircraft, vehicles or machines produced in accordance with subparagraph 3(b);
(d) electrical and electronic equipment within the scope of Directive 2011/65/EU.

 

5. For the purposes of this entry ‘aircraft’ means one of the following:
(a) a civil aircraft produced in accordance with a type certificate issued under Regulation (EU) No 216/2008 of the European Parliament and of the Council3 or with a design approval issued under the national regulations of a contracting State of the International Civil Aviation Organisation (ICAO), or for which a certificate of airworthiness has been issued by an ICAOcontracting State under Annex 8 to the Convention on International CivilAviation;
(b) a military aircraft.

 

Entry 68

Perfluorooctanoic acid (PFOA) and its salts.
 CAS No 335-67-1, EC No 206-397-9

 

Any related substance (including its salts and polymers) having a linear or branched perfluoroheptyl group with the formula C7F15- directly attached to another carbon atom, as one of the structural elements.

 

Any related substance (including its salts and polymers) having a linear or branched perfluorooctyl group with the formula C8F17- as one of the structural elements.

 

The following substances are excluded from this designation:
— C8F17-X, where X = F, Cl, Br.
— C8F17-C(=O)OH, C8F17-C(=O)O-X′ or C8F17-CF2-X′ (where X′ = any group, including salts).

 

Conditions of restriction

1. Shall not be manufactured, or placed on the market as substances on their own from 4 July 2020.

 

2. Shall not, from 4 July 2020, be used in the production of, or placed on the market in:
(a) another substance, as a constituent;
(b) a mixture;
(c) an article,
in a concentration equal to or above 25 ppb of PFOA including its salts or 1 000 ppb of one or a combination of PFOA-related substances.

 

3. Points 1 and 2 shall apply from:
(a) 4 July 2022 to:
 (i) equipment used to manufacture semi-conductors;
 (ii) latex printing inks.

 

(b) 4 July 2023 to:
 (i) textiles for the protection of workers from risks to their health and safety;
 (ii) membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment;
 (iii) plasma nano-coatings.

 

(c) 4 July 2032 to medical devices other than implantable medical devices within the scope of Directive 93/42/EEC.

 

4. Points 1 and 2 shall not apply to any of the following:
(a) perfluorooctane sulfonic acid and its derivatives, which are listed in Part A of Annex I to Regulation (EC) No 850/2004;

 

(b) the manufacture of a substance where this occurs as an unavoidable by-product of the manufacture of fluorochemicals with a carbon chain equal to or shorter than 6 atoms;

 

(c) a substance that is to be used, or is used as a transported isolated intermediate, provided that the conditions in points (a) to (f) of Article 18(4) of this Regulation are met;

 

(d) a substance, constituent of another substance or mixture that is to be used, or is used:
 (i) in the production of implantable medical devices within the scope of Directive 93/42/EEC;
 (ii) in photographic coatings applied to films, papers or printing plates;
 (iii) in photo-lithography processes for semiconductors or in etching processes for compound semiconductors;

 

(e) concentrated fire-fighting foam mixtures that were placed on the market before 4 July 2020 and are to be used, or are used in the production of other fire-fighting foam mixtures.

 

5. Point 2(b) shall not apply to fire-fighting foam mixtures which were:
(a) placed on the market before 4 July 2020; or
(b) produced in accordance with point 4(e), provided that, where they are used for training purposes, emissions to the environment are minimised and effluents collected are safely disposed of.

 

6. Point 2(c) shall not apply to:
(a) articles placed on the market before 4 July 2020;
(b) implantable medical devices produced in accordance with point 4(d)(i);
(c) articles coated with the photographic coatings referred to in point 4(d)(ii);
(d) semiconductors or compound semiconductors referred to in point 4(d)(iii)

 

Entry 69

Methanol
 CAS No 67-56-1, EC No 200-659-6

 

Conditions of restriction

Shall not be placed on the market to the general public after 9 May 2019 in windscreen washing or defrosting fluids, in a concentration equal to or greater than 0,6 % by weight.

 

Entry 70

Octamethylcyclotetrasiloxane (D4)
 CAS No 556-67-2, EC No 209-136-7
Decamethylcyclopentasiloxane (D5)
 CAS No 541-02-6, EC No 208-764-9

 

Conditions of restriction

1. Shall not be placed on the market in wash-off cosmetic products in a concentration equal to or greater than 0,1 % by weight of either substance, after 31 January 2020.

 

2. For the purposes of this entry, “wash-off cosmetic products” means cosmetic products as defined in Article 2(1)(a) of Regulation (EC) No 1223/2009 that, under normal conditions of use, are washed off with water after application.

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