The European Commission has introduced a regulation adding an extra entry in Annex XVII of REACH Regulation (EC) No 1907/2006 for restriction on Perfluorooctanoic acid (PFOA), salts and PFOA-related substances.

Commission Regulation (EU) 2017/1000 as regards perfluorooctanoic acid (PFOA), its salts and PFOA-related substances amends Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) has been published in the Official Journal.

The restriction will be implemented under Entry 68 of Annex XVII of REACH and a link to the Regulation is below:

http://eur-lex.europa.eu/legal-content/EN/
TXT/?uri=uriserv:OJ.L_.2017.150.01.0014.01.ENG&toc=OJ:L:2017:150:TOC

Perfluoroctanoic acid and related substances have been used in a variety of consumer products for many years. One of the significant uses of the substance has been used to provide water-resistant coatings to textile products. PFOA-related substances have also been used to provide stain-resistant coatings to apparel, other textile products and to carpets.

The limits have been set for PFOA and its salts and also for products containing these substances.

The restrictions on the use of substances states:

• PFOA and its salts shall not be manufactured, or placed on the market as substance on their own form.
  The substances are also restricted in mixtures and in articles as below:
• PFOA and its salts shall not be used when the concentration of PFOA including its salts exceeds 25 ppb or the concentration of one or a combination of PFOA-related substances exceeds 1000 ppb in the production of, or placed on the market in:
1. Another substance, as a constituent;
2. A mixture;
3. Any part of an article

The restrictions will be applicable from 4 July 2020.

There are some articles which are indicated to be within the scope of the restriction, but the restrictions will be applicable from a later date:

• Equipment used to manufacture semi-conductors
• Latex printing inks
• Textiles for the protection of workers
• Membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment
• Plasma nano-coatings
• Medical devices other than implantable medical devices

Points 1 and 2 shall not apply to any of the following:

1. perfluorooctane sulfonic acid and its derivatives, which are listed in Part A of Annex I to Regulation (EC) No 850/2004;
2. 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;
3. 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;
4. a substance, constituent of another substance or mixture that is to be used, or is used:
   1. in the production of implantable medical devices within the scope of Directive 93/42/EEC;
   2. in photographic coatings applied to films, papers or printing plates;
   3. in photo-lithography processes for semiconductors or in etching processes for compound semiconductors;
5. 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.

Point 2(b) shall not apply to fire-fighting foam mixtures which were:

1. placed on the market before 4 July 2020; or
2. 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.

Point 2(c) shall not apply to:

1. articles placed on the market before 4 July 2020;
2. implantable medical devices produced in accordance with point 4(d)(i);
3. articles coated with the photographic coatings referred to in point 4(d)(ii);
4. semiconductors or compound semiconductors referred to in point 4(d)(iii).

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