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Entry 51

2019.1.11 Entry 51 update

The following phthalates (or other CAS and EC numbers covering the substance):
以下のフタル酸エステル類

(a) Bis (2-ethylhexyl) phthalate (DEHP)
　フタル酸ビス(2-エチルヘキシル）(DEHP)
　CAS No 117-81-7, EC No 204-211-0

(b) Dibutyl phthalate (DBP)
　フタル酸ジブチル(DBP)
　CAS No 84-74-2, EC No 201-557-4

(c) Benzyl butyl phthalate (BBP)
　フタル酸ベンジルブチル(BBP)
　CAS No 85-68-7,EC No 201-622-7

(d) Diisobutyl phthalate (DIBP)
　フタル酸ジイソブチル(DIBP)
　CAS No 84-69-5, EC No 201-553-2

Conditions of restriction

1. Shall not be used as substances or in mixtures, individually or in any combination of the phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material, in toys and childcare articles.

2. Shall not be placed on the market in toys or childcare articles, individually or in any combination of the first three phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material.
In addition, DIBP shall not be placed on the market after 7 July 2020 in toys or childcare articles, individually or in any combination with the first three phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight of the plasticised material.

3. Shall not be placed on the market after 7 July 2020 in articles, individually or in any combination of the phthalates listed in column 1 of this entry, in a concentration equal to or greater than 0,1 % by weight ofthe plasticised material in the article.

4. Paragraph 3 shall not apply to:
(a) articles exclusively for industrial or agricultural use, or for use exclusively in the open air, provided that no plasticised material comes into contact with human mucous membranes or into prolonged contact with human skin;
(b) aircraft, placed on the market before 7 January 2024, or articles, whenever placed on the market, for use exclusively in the maintenance or repair of those aircraft, where those articles are essential for the safety and airworthiness of the aircraft;
(c) motor vehicles within the scope of Directive 2007/46/EC, placed on the market before 7 January 2024, or articles, whenever placed on the market, for use exclusively in the maintenance or repair of those vehicles, where the vehicles cannot function as intended without those articles;
(d) articles placed on the market before 7 July 2020;
(e) measuring devices for laboratory use, or parts thereof;
(f) materials and articles intended to come into contact with food within the scope of Regulation (EC) No 1935/2004 or Commission Regulation (EU) No 10/20111;
(g) medical devices within the scope of Directives 90/385/EEC, 93/42/EEC or 98/79/EC, or parts thereof;
(h) electrical and electronic equipment within the scope of Directive 2011/65/EU;
(i) the immediate packaging of medicinal products within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC;
(j) toys and childcare articles covered by paragraphs 1 or 2.

5. For the purposes of paragraphs 1, 2, 3 and 4(a),
(a) ‘plasticised material’ means any of the following homogeneous materials:
- polyvinyl chloride (PVC), polyvinylidene chloride (PVDC),polyvinyl acetate (PVA),polyurethanes,
- any other polymer (including, inter alia, polymer foams and rubber material) except silicone rubber and natural latex coatings,
- surface coatings, non-slip coatings, finishes, decals, printed designs,
- adhesives, sealants, paints and inks.
(b) ‘prolonged contact with human skin’ means continuous contact of more than 10 minutes duration or intermittent contact over a period of 30 minutes, per day.
(c) ‘childcare article’ shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.

6. For the purposes of paragraph 4(b), ‘aircraft’ means one of the following:
(a) a civil aircraft produced in accordance with a type certificate issued under Regulation (EC) No 216/2008 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 ICAO contracting State under Annex 8 to the Convention on International Civil Aviation, signed on December 7, 1944 , in Chicago;
(b) a military aircraft.

Entry 52

The following phthalates (or other CAS and EC numbers covering the substance):
以下のフタル酸エステル類

(a) Di-isononyl phthalate (DINP)
　フタル酸ジイソノニル(DINP)
　CAS No 28553-12-0 and 68515-48-0, EC No 249-079-5 and 271-090-9

(b) Di-isodecyl phthalate (DIDP)
　フタル酸ジイソデシル(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)
　フタル酸ジ-n-オクチル(DNOP)
　CAS No 117-84-0, EC No 204-214-7

Conditions of restriction

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. Regulation (EU) No 326/2015: paragraph 3 is deleted.)

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.

Entry 54

2-(2-methoxyethoxy)ethanol (DEGME)
2-(2-メトキシエトキシ)エタノール(DEGME)
CAS No 111-77-3, EC No 203-906-6

Conditions of restriction

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.

Entry 55

2-(2-butoxyethoxy)ethanol (DEGBE)
2-(2-ブトキシエトキシ)エタノール(DEGBE)
CAS No 112-34-5, EC No 203-961-6

Conditions of restriction

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’.

Entry 56

Methylenediphenyl diisocyanate (MDI)
メチレンジフェニルジイソシアネート（MDI）
　CAS No 26447-40-5, EC No 247-714-0

including the following specific isomers:
以下の特定の異性体を含む

(a) 4,4’-Methylenediphenyl diisocyanate:
　4,4'-メチレンジフェニルジイソシアネート
　CAS No 101-68-8, EC No 202-966-0

(b) 2,4’-Methylenediphenyl diisocyanate:
　2,4'-メチレンジフェニルジイソシアネート
　CAS No 5873-54-1, EC No 227-534-9

(c) 2,2’-Methylenediphenyl diisocyanate:
　2,2'-メチレンジフェニルジイソシアネート
　CAS No 2536-05-2, EC No 219-799-4

Conditions of restriction

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(*);
(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.
(*) OJ L 399, 30.12.1989, p. 18.

Entry 57

Cyclohexane
シクロヘキサン
　CAS No 110-82-7, EC No 203-806-2

Conditions of restriction

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.’.

Entry 58

Ammonium nitrate (AN)
硝酸アンモニウム(AN)
CAS No 6484-52-2, EC No 229-347-8

Conditions of restriction

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(*).

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 (**);

(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 (***);

(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 socio-economic 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.
(*) OJ L 304, 21.11.2003, p. 1.
(**) OJ L 121, 15.5.1993, p. 20.
(***) OJ L 270, 21.10.2003, p. 1.

Entry 59

Dichloromethane
ジクロロメタン
CAS No 75-09-2, EC No 200-838-9

Conditions of restriction

1. Paint strippers containing dichloromethane in a concentration equal to or greater than 0,1 % by weight shall not be:

(a) placed on the market for the first time for supply to the general public or to professionals after 6 December 2010;
(b) placed on the market for supply to the general public or to professionals after 6 December 2011;
(c) used by professionals after 6 June 2012.

For the purposes of this entry:
(i) ‘professional’ means any natural or legal person, including workers and selfemployed workers undertaking paint stripping in the course of their professional activity outside an industrial installation;
(ii) ‘industrial installation’ means a facility used for paint stripping activities.

2. By way of derogation from paragraph 1, Member States may allow on their territories and for certain activities the use, by specifically trained professionals, of paint strippers containing dichloromethane and may allow the placing on the market of such paint strippers for supply to those professionals.

Member States making use of this derogation shall define appropriate provisions for the protection of the health and safety of those professionals using paint strippers containing dichloromethane and shall inform the Commission thereof.

Those provisions shall include a requirement that a professional shall hold a certificate that is accepted by the Member State in which that professional operates, or provide other documentary evidence to that effect, or be otherwise approved by that Member State, so as to demonstrate proper training and competence to safely use paint strippers containing dichloromethane.

The Commission shall prepare a list of the Member States which have made use of the derogation in this paragraph and make it publicly available over the Internet.

3. A professional benefiting from the derogation referred to in paragraph 2 shall operate only in Member States which have made use of that derogation. The training referred to in paragraph 2 shall cover as a minimum:

(a) awareness, evaluation and management of risks to health, including information on existing substitutes or processes, which under their conditions of use are less hazardous to the health and safety of workers;
(b) use of adequate ventilation;
(c) use of appropriate personal protective equipment that complies with Directive 89/686/EEC.

Employers and self-employed workers shall preferably replace dichloromethane with a chemical agent or process which, under its conditions of use, presents no risk, or a lower risk, to the health and safety of workers.

Professional shall apply all relevant safety measures in practice, including the use of personal protective equipment.

4. Without prejudice to other Community legislation on workers protection, paint strippers containing dichloromethane in concentrations equal to or greater than 0,1 % by weight may be used in industrial installations only if the following minimum conditions are met:

(a) effective ventilation in all processing areas, in particular for the wet processing and the drying of stripped articles: local exhaust ventilation at strip tanks supplemented by forced ventilation in those areas, so as to minimise exposure and to ensure compliance, where technically feasible, with relevant occupational exposure limits;

(b) measures to minimise evaporation from strip tanks comprising: lids for covering strip tanks except during loading and unloading; suitable loading and unloading arrangements for strip tanks; and wash tanks with water or brine to remove excess solvent after unloading;

(c) measures for the safe handling of dichloromethane in strip tanks comprising: pumps and pipework for transferring paint stripper to and from strip tanks; and suitable arrangements for safe cleaning of tanks and removal of sludge;

(d) personal protective equipment that complies with Directive 89/686/EEC comprising: suitable protective gloves, safety goggles and protective clothing; and appropriate respiratory protective equipment where compliance with relevant occupational exposure limits cannot be otherwise achieved;

(e) adequate information, instruction and training for operators in the use of such equipment.

5. Without prejudice to other Community provisions concerning the classification, labelling and packaging of substances and mixtures, by 6 December 2011 paint strippers containing dichloromethane in a concentration equal to or greater than 0,1 % by weight shall be visibly, legibly and indelibly marked as follows:

‘Restricted to industrial use and to professionals approved in certain EU Member States —verify where use is allowed.’

Entry 60

Acrylamide
アクリルアミド
CAS No 79-06-1

Conditions of restriction

Shall not be placed on the market or used as a substance or constituent of mixtures in a concentration, equal to or greater than 0,1 % by weight for grouting applications after 5 November 2012.