REACH規則の附属書XVII制限リストに「C9-C14 PFCAs」が追加

2021年08月05日、EUにおける一般・工業用化学品の基本法令であるREACH規則の附属書XVIIを改正する規則 (EU) 2021/1297が公布されました。施行日は2021年08月25日ですが、附属書XVII制限リストに関係する改正の場合は、要件個別の遵守期限を確認する必要があります。

追加された「C9-C14 PFCAs」とは？

規制対象となったPFCAとは”perfluorocarboxylic acids”の略でC9-C14とは炭素数を表しています。昨今、世界各国で厳しい規制が整備され始めたペルフルオロオクタン酸（PFOA）などの炭素原子の鎖が9個未満のペルフルオロ物質およびポリフルオロ物質の製造時に、C9-C14 PFCAsは意図しない副産物としてEUで発生しているとされています。

C9-C14 PFCAsのうち、鎖中に9個の炭素原子を含むperfluorononan-1-oic acid (‘PFNA’)および鎖中に10個の炭素原子を含むnonadecafluorodecanoic acid (‘PFDA’)とそれらナトリウム塩およびアンモニウム塩は、既に附属書XIV認可対象物質の候補となる物質リスト、いわゆる候補リストに既に収載され、高懸念物質（SVHC）に特定されていました。生殖毒性、難分解性・生物蓄積性・毒性（PBT）がその特定理由として挙げられています。加えて、欧州における化学物質の分類・表示・包装の基本事項を規定するCLP規則では、調和分類表示（CLH）制度により、発がん性カテゴリー2、生殖毒性カテゴリー1Bにそれらの物質を分類しています。

そのほか、鎖中に11個の炭素原子を含むhenicosafluoroundecanoic acid (‘PFUnDA’) 、鎖中に12個の炭素原子を含むtricosafluorododecanoic acid (‘PFDoDA’) 、鎖中に13個の炭素原子を含むpentacosafluorotridecanoic acid (‘PFTrDA’) および鎖中に14個の炭素原子を含むheptacosafluorotetradecanoic acid (‘PFTDA’) は、非常に高い難分解性および生物蓄積性（vPvB）物質として、候補リストに収載されています。

下記、対象物質に記載のあるC9-C14 PFCA関連物質（C9-C14 PFCA-related substance）は、環境中で C9-C14 PFCA に変化・分解されることから、それぞれ PBT物質、vPvB物質とみなされています。

対象物質

対象物質は次のように特定されています。

‘68. Linear and branched perfluorocarboxylic acids of the formula CnF2n +1-C(= O)OH where n = 8, 9, 10, 11, 12, or 13 (C9-C14 PFCAs),

including their salts, and any combinations thereof;

Any C9-C14 PFCA-related substance having a perfluoro group with the formula CnF2n +1- directly attached to another carbon atom, where n = 8, 9, 10, 11, 12, or 13, including their salts and any combinations thereof;

Any C9-C14 PFCA-related substance having a perfluoro group with the formula CnF2n +1- that it is not directly attached to another carbon atom, where n = 9, 10, 11, 12, 13 or 14 as one of the structural elements, including their salts and any combinations thereof.

The following substances are excluded from this designation

— CnF2n +1-X, where X = F, Cl, or Br where n = 9, 10, 11, 12, 13 or 14, including any combinations thereof,

— CnF2n +1-C(= O)OX’ where n> 13 and X’=any group, including salts.

制限条件

遵守期限は各要件別、用途別の要件別に細かく規定されています。最も注目すべきは影響範囲が大きい第2項の規定です。2023年02月25日から、物質や混合物だけでなく、成形品への含有も原則禁止となります。

1. Shall not be manufactured, or placed on the market as substances on their own from 25 February 2023.

2. Shall not, from 25 February 2023, be used in, or placed on the market in:

(a) another substance, as a constituent;

(b) a mixture;

(c) an article,

except if the concentration in the substance, the mixture, or the article is below 25 ppb for the sum of C9-C14 PFCAs and their salts or 260 ppb for the sum of C9-C14 PFCA-related substances.

3. By way of derogation to paragraph 2, the concentration limit shall be 10 ppm for the sum of C9-C14 PFCAs, their salts and C9-C14 PFCA related substances, where they are present in a substance to be used as a transported isolated intermediate, provided that the conditions in points (a) to (f) of Article 18(4) of this Regulation are met for the manufacturing of fluorochemicals with a perfluoro carbon chain length equal to or shorter than 6 atoms. The Commission shall review this limit no later than 25 August 2023.

4. Paragraph 2 shall apply from 4 July 2023 to:

(i) textiles for oil- and water-repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety;

(ii) the manufacture of polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF) for the production of:

— high performance, corrosion resistant gas filter membranes, water filter membranes and membranes for medical textiles;

— industrial waste heat exchanger equipment;

— industrial sealants capable of preventing leakage of volatile organic compounds and PM 2,5 particulates

5. By way of derogation to paragraph 2, the use of C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances shall be allowed until 4 July 2025 for:

(i) photolithography or etch processes in semiconductor manufacturing;

(ii) photographic coatings applied to films;

(iii) invasive and implantable medical devices;

(iv) fire-fighting foam for liquid fuel vapour suppression and liquid fuel fire (Class B fires) already installed in systems, including both mobile and fixed systems, subject to the following conditions:

— fire-fighting foam that contains or may contain C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances shall not be used for training;

— fire-fighting foam that contains or may contain C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances shall not be used for testing unless all releases are contained;

— from 1 January 2023, uses of fire-fighting foam that contains or may contain C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances shall only be allowed to sites where all releases can be contained;

— fire-fighting foam stockpiles that contain or may contain C9-C14 PFCAs, their salts and C9-C14 PFCA-related substances shall be managed in accordance with Article 5 of Regulation (EU) 2019/1021.

6. Paragraph 2(c) shall not apply to articles placed on the market before 25 February 2023.

7. Paragraph 2 shall not apply to the can coating for pressurised metered-dose inhalers until 25 August 2028.

8. Paragraph 2 (c) shall apply from 31 December 2023 to:

(a) semiconductors on their own;

(b) semiconductors incorporated in semi-finished and finished electronic equipment.

9. Paragraph 2(c) shall apply from 31 December 2030 to semiconductors used in spare or replacement parts for finished electronic equipment placed on the market before 31 December 2023.

10. Until 25 August 2024, the concentration limit referred to in paragraph 2 shall be 2 000 ppb for the sum of C9-C14 PFCAs in fluoroplastics and fluoroelastomers that contain perfluoroalkoxy groups. From 25 August 2024, the concentration limit shall be 100 ppb for the sum of C9-C14 PFCAs, in fluoroplastics and fluoroelastomers that contain perfluoroalkoxy groups. All emissions of C9-C14 PFCAs during the manufacture and use of fluoroplastics and fluoroelastomers that contain perfluoroalkoxy groups shall be avoided and, if not possible, reduced as far as technically and practically possible. This derogation shall not apply to articles referred to in paragraph 2(c). The Commission shall review this derogation no later than 25 August 2024.

11. The concentration limit referred to in paragraph 2 shall be 1 000 ppb for the sum of C9-C14 PFCAs, where these are present in PTFE micro powders produced by ionising irradiation or by thermal degradation, as well as in mixtures and articles for industrial and professional uses containing PTFE micro powders. All emissions of C9-C14 PFCAs during the manufacture and use of PTFE micro powders shall be avoided and, if not possible, reduced as far as technically and practically possible. The Commission shall review this derogation no later than 25 August 2024.

12. For the purposes of this entry, C9-C14 PFCA-related substances are substances that, based on their molecular structure, are considered to have the potential to degrade or be transformed to C9-C14 PFCAs.’