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EU adds PFOA restrictions to EU REACH Annex XVII

From: 中鼎检测 Date: 2017-06-15 Tits: 7566 Times

On June 14, 2017, the European Commission published Commission Regulation (EU) 2017/1000 which amended REACH Annex XVII by creating a new entry 68 to include a new restriction of Perfluorooctanoic acid (PFOA), its salts and PFOA-related substances in the Official Journal of the European Union (OJ). According to the regulation, from 4 July 2020, the substances, mixtures or articles in a concentration equal to or above 25 ppb of PFOA including its salts or 1000ppb of one or a combination of PFOA-related substances shall not be used in the production, or placed on the market.

In Annex XVII to Regulation (EC) No 1907/2006, the following entry is added:

68. Perfluorooctanoic acid (PFOA)

CAS  No 335-67-1

EC  No 206-397-9

and  its salts.

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).

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  000ppb 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).’

The applications of PFOA and its salts and related substances:

Perfluorooctanoic acid (PFOA), its salts and PFOA-related substances have some specific properties such as high friction resistance, dielectricality, resistance to heat and chemical agents, and low surface energy. They are used in a wide variety of applications such as in the fluoropolymer and fluoroelastomer production, as surfactants in fire-fighting foams, and in textile and paper production to provide water, grease, oil and/or dirt repellency.

CTT advice: Relevant enterprises shall focus on the regulation, and develop solution during the transition period to restrict the concentrations of PFOA, its saltsand PFOA-related substances in the products which ensure the relevant products to meet the requirements of the regulations and avoid trade risks.

Commission Regulation(EU) 2017/1000 link:http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1497486764566&uri=CELEX:32017R1000

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