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制限条件 Entry 71-

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Entry 71

1-methyl-2-pyrrolidone (NMP)
1-メチル-2-ピロリドン
CAS No 872-50-4, EC No 212-828-1

 

Conditions of restriction

1. Shall not be placed on the market as a substance on its own or in mixtures in a concentration equal to or greater than 0,3 % after 9 May 2020 unless manufacturers, importers and downstream users have included in the relevant chemical safety reports and safety data sheets, Derived No-Effect Levels (DNELs) relating to exposure of workers of 14,4 mg/m3 for exposure by inhalation and 4,8 mg/kg/day for dermal exposure.

 

2. Shall not be manufactured, or used, as a substance on its own or in mixtures in a concentration equal to or greater than 0,3 % after 9 May 2020 unless manufacturers and downstream users take the appropriate risk management measures and provide the appropriate operational conditions to ensure that exposure of workers is below the DNELs specified in paragraph 1.

 

3. By way of derogation from paragraphs 1 and 2, the obligations laid down therein shall apply from 9 May 2024 in relation to placing on the market for use, or use, as a solvent or reactant in the process of coating wires.

1. 2020年5月9日以降、製造者、輸入者および川下使用者が、関連する化学物質安全性報告書および安全データシートに、労働者の曝露に関する導出無影響量(DNEL)を、吸入による曝露の場合は14,4 mg/m3、経皮による曝露の場合は4,8 mg/kg/dayと記載しない限り、0.3%以上の濃度で、単独または混合物として市場に出してはならない。

 

2. 製造者および川下使用者が、労働者の暴露が第1項で指定されたDNEL以下であることを保証するために、適切なリスク管理措置を講じ、適切な運用条件を提供しない限り、2020年5月9日以降、単体または混合物中に0.3%以上の濃度で物質として製造または使用してはならない。

 

3. 第1項および第2項の適用除外として、ワイヤーの被覆工程における溶剤または反応剤としての使用、または使用のための市場投入に関しては、2024年5月9日より、ここに定められた義務が適用される。

Entry 72

The following substances which are classified as carcinogenic, mutagenic or toxic for reproduction, category 1A or 1B (See group members)
The substances listed in column 1 of the Table in Appendix 12

発がん性、変異原性または生殖毒性のカテゴリー1Aまたは1Bに分類される以下の物質(グループメンバー参照)。

付録12の表の1列目に記載されている物質

 

Conditions of restriction

1. Shall not be placed on the market after 1 November 2020 in any of the following:
(a) clothing or related accessories;
(b) textiles other than clothing which, under normal or reasonably foreseeable conditions of use, come into contact with human skin to an extent similar to clothing;
(c) footwear;
if the clothing, related accessory, textile other than clothing or footwear is for use by consumers and the substance is present in a concentration, measured in homogeneous material, equal to or greater than that specified for that substance in Appendix 12.

1. 以下のいずれかにおいて、2020年11月1日以降に市場に出してはならない。

(a) 衣類または関連付属品。
(b) 衣類以外の織物で、通常の使用条件または合理的に予見可能な使用条件の下で、衣類と同様の程度に人の皮膚と接触するもの。
(c) 履物。
衣類、関連付属品、衣類以外の繊維製品、または履物が消費者の使用に供されるものであり、その物質が均質材料で測定された濃度が付属書12でその物質について規定されている濃度以上で存在する場合。

 

 

2. By way of derogation, in relation to the placing on the market of formaldehyde [CAS No 50-00-0] in jackets, coats or upholstery, the relevant concentration for the purposes of paragraph 1 shall be 300 mg/kg during the period between 1 November 2020 and 1 November 2023. The concentration specified in Appendix 12 shall apply thereafter.

2. 特例として、ジャケット、コート、椅子張り生地に含まれるホルムアルデヒド[CAS No.50-00-0]の上市に関しては、2020年11月1日から2023年11月1日までの間、第1項の目的である関連濃度は300mg/kgとする。その後は、付属書12に規定された濃度が適用されるものとする。

 

3. Paragraph 1 shall not apply to:
(a) clothing, related accessories or footwear, or parts of clothing, related accessories or footwear, made exclusively of natural leather, fur or hide;
(b) non-textile fasteners and non-textile decorative attachments;
(c) second-hand clothing, related accessories, textiles other than clothing or footwear
(d) wall-to-wall carpets and textile floor coverings for indoor use, rugs and runners.

3. 第1項は、以下には適用されない。

(a) 天然皮革、毛皮、皮のみで作られた衣類、関連付属品、履物、または衣類、関連付属品、履物の一部。
(b) 織物ではないファスナーおよび織物ではない装飾用アタッチメント。
(c) 中古の衣類、関連付属品、衣類・履物以外の繊維製品
(d) 屋内用の壁から壁までのカーペットおよび繊維製の床材、ラグおよびランナー。

 

4. Paragraph 1 shall not apply to clothing, related accessories, textiles other than clothing, or footwear within the scope of Regulation (EU) 2016/425 of the European Parliament and of the Council1 or Regulation (EU) 2017/745 of the European Parliament and of the Council2.

4. 第1項は、欧州議会及び理事会の規則(EU)2016/4251又は欧州議会及び理事会の規則(EU)2017/7452の範囲内の衣類、関連付属品、衣類以外の織物、又は履物には適用されない。

 

5. Paragraph 1(b) shall not apply to disposable textiles. ‘Disposable textiles’ means textiles that are designed to be used only once or for a limited time and are not intended for subsequent use for the same or a similar purpose.

5. 第1項(b)は、使い捨てのテキスタイルには適用されない。使い捨てテキスタイル」とは、一度だけまたは限られた期間のみ使用することを目的とし、同一または類似の目的での再使用を意図していないテキスタイルをいう。

 

6. Paragraphs 1 and 2 shall apply without prejudice to the application of any stricter restrictions set out in this Annex or in other applicable Union legislation.

6. 第1項および第2項は、本付属書または他の適用される組合法に定められたより厳しい制限の適用を妨げることなく適用されるものとする。

 

7.The Commission shall review the exemption in paragraph 3(d) and, if appropriate, modify that point accordingly.

7.欧州委員会は、第3項(d)の除外事項を見直し、適切であれば、その点を適宜修正する。

 

Entry 73

(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) silanetriol
Any of its mono-, di- or tri-O-(alkyl) derivatives (TDFAs)
(3,3,4,4,5,5,6,6,7,7,8,8,8-トリデカフルオロオクチル) シラントリオール
そのモノ-、ジ-またはトリ-O-(アルキル)誘導体(TDFAs)

 

Conditions of restriction

1.Shall not be placed on the market for supply to the general public after 2 January 2021 individually or in any combination, in a concentration equal to or greater than 2 ppb by weight of the mixtures containing organic solvents, in spray products.

1.2021年1月2日以降、スプレー製品において、有機溶剤を含む混合物の重量で2ppb以上の濃度で、個別に、またはいかなる組み合わせでも、一般大衆に供給するために市場に出してはならない。

 

2.For the purpose of this entry, “spray products” means aerosol dispensers, pump sprays, trigger sprays, marketed for proofing or impregnation spray applications.

2.本項目において、「スプレー製品」とは、プルーフィングまたは含浸スプレー用に販売されているエアゾールディスペンサー、ポンプスプレー、トリガースプレーをいう。

 

3.Without prejudice to the implementation of other Union provisions concerning the classification, packaging and labelling of substances and mixtures, the packaging of spray products containing (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) silanetriol and/or TDFAs combined with organic solvents as referred to in paragraph 1 and placed on the market for professional use shall be marked clearly and indelibly: “for professional users only” and “Fatal if inhaled” with the pictogram GHS06.

3.物質および混合物の分類、包装、表示に関する他の連合規定の実施を損なうことなく、(3,3,4,4,5,5,6,6,7,7,8,8-トリデカフルオロオクチル)シラネトリオールおよび/またはTDFAと、第1項で言及されている有機溶剤とを組み合わせたものを含み、業務用として市販されるスプレー製品の包装には、はっきりと消えないように表示すること。「専門ユーザーのみ」および「吸入すると生命に危険」のピクトグラムGHS06を明確かつ不可解に表示しなければならない。

 

4.Section 2.3 of Safety Data Sheets shall contain the following information: “mixtures of (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) silanetriol and/or any of its mono-, di- or tri-O-(alkyl) derivatives in a concentration equal to or greater than 2 ppb and organic solvents in spray products, are for professional users only and marked ‘Fatal if inhaled’”.

4.安全データシートの第2.3項には、以下の情報を記載すること。"スプレー製品に含まれる2ppb以上の濃度の(3,3,4,4,5,6,6,7,7,8,8-トリデカフルオロオクチル)シラネトリオールおよび/またはそのモノ-、ジ-、トリ-O-(アルキル)誘導体と有機溶剤との混合物は、専門家ユーザーのみが使用でき「吸入すると生命に危険」と表示されていること。

 

5. Organic solvents referred to in paragraph 1, 3, and 4 include organic solvents used as aerosol propellants.

5. 第1項、第3項、第4項の有機溶剤には、エアゾールの噴射剤として使用される有機溶剤も含まれます。

 

Entry 74

Diisocyanates, O = C=N-R-N = C=O, with R an aliphatic or aromatic hydrocarbon unit of unspecified length

 

Conditions of restriction

1. Shall not be used as substances on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) after 24 August 2023, unless:
(a) the concentration of diisocyanates individually and in combination is less than 0,1 % by weight, or
(b) the employer or self-employed ensures that industrial or professional user(s) have successfully completed training on the safe use of diisocyanates prior to the use of the substance(s) or mixture(s).

 

2. Shall not be placed on the market as substances on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) after 24 February 2022, unless:
(a) the concentration of diisocyanates individually and in combination is less than 0,1 % by weight, or
(b) the supplier ensures that the recipient of the substance(s) or mixture(s) is provided with information on the requirements referred to in point (b) of paragraph 1 and the following statement is placed on the packaging, in a manner that is visibly distinct from the rest of the label information: “As from 24 August 2023 adequate training is required before industrial or professional use”.

 

3. For the purpose of this entry “industrial and professional user(s)” means any worker or self-employed worker handling diisocyanates on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) or supervising these tasks.

 

4. The training referred to in point (b) of paragraph 1 shall include the instructions for the control of dermal and inhalation exposure to diisocyanates at the workplace without prejudice to any national occupational exposure limit value or other appropriate risk management measures at national level. Such training shall be conducted by an expert on occupational safety and health with competence acquired by relevant vocational training. That training shall cover as a minimum:
(a) the training elements in point (a) of paragraph 5 for all industrial and professional use(s).
(b) the training elements in points (a) and (b) of paragraph 5 for the following uses:
— handling open mixtures at ambient temperature (including foam tunnels);
— spraying in a ventilated booth;
— application by roller;
— application by brush;
— application by dipping and pouring;
— mechanical post treatment (e.g. cutting) of not fully cured articles which are not warm anymore;
— cleaning and waste;
— any other uses with similar exposure through the dermal and/or inhalation route;
(c) the training elements in points (a), (b) and (c) of paragraph 5 for the following uses:
— handling incompletely cured articles (e.g. freshly cured, still warm);
— foundry applications;
— maintenance and repair that needs access to equipment;
— open handling of warm or hot formulations (> 45 °C);
— spraying in open air, with limited or only natural ventilation (includes large industry working halls) and spraying with high energy (e.g. foams, elastomers);
— and any other uses with similar exposure through the dermal and/or inhalation route.

 

5. Training elements:
(a) general training, including on-line training, on:
— chemistry of diisocyanates;
— toxicity hazards (including acute toxicity);
— exposure to diisocyanates;
— occupational exposure limit values;
— how sensitisation can develop;
— odour as indication of hazard;
— importance of volatility for risk;
— viscosity, temperature, and molecular weight of diisocyanates;
— personal hygiene;
— personal protective equipment needed, including practical instructions for its correct use and its limitations;
— risk of dermal contact and inhalation exposure;
— risk in relation to application process used;
— skin and inhalation protection scheme;
— ventilation;
— cleaning, leakages, maintenance;
— discarding empty packaging;
— protection of bystanders;
— identification of critical handling stages;
— specific national code systems (if applicable);
— behaviour-based safety;
— certification or documented proof that training has been successfully completed
(b) intermediate level training, including on-line training, on:
— additional behaviour-based aspects;
— maintenance;
— management of change;
— evaluation of existing safety instructions;
— risk in relation to application process used;
— certification or documented proof that training has been successfully completed
(c) advanced training, including on-line training, on:
— any additional certification needed for the specific uses covered;
— spraying outside a spraying booth;
— open handling of hot or warm formulations (> 45 °C);
— certification or documented proof that training has been successfully completed

 

6. The training shall comply with the provisions set by the Member State in which the industrial or professional user(s) operate. Member States may implement or continue to apply their own national requirements for the use of the substance(s) or mixture(s), as long as the minimum requirements set out in paragraphs 4 and 5 are met.

 

7. The supplier referred to in point (b) of paragraph 2 shall ensure that the recipient is provided with training material and courses pursuant to paragraphs 4 and 5 in the official language(s) of the Member State(s) where the substance(s) or mixture(s) are supplied. The training shall take into consideration the specificity of the products supplied, including composition, packaging, and design.

 

8. The employer or self-employed shall document the successful completion of the training referred to in paragraphs 4 and 5. The training shall be renewed at least every five years.

 

9. Member States shall include in their reports pursuant to Article 117(1) the following information:
(a) any established training requirements and other risk management measures related to the industrial and professional uses of diisocyanates foreseen in national law;
(b) the number of cases of reported and recognised occupational asthma and occupational respiratory and dermal diseases in relation to diisocyanates;
(c) national exposure limits for diisocyanates, if there are any;
Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
(d) information about enforcement activities related to this restriction.

 

10. This restriction shall apply without prejudice to other Union legislation on the protection of safety and health of workers at the workplace.

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