A new restricted substance PFOA added into REACH regulation Annex XVII
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On 14 June, 2017, the EU official journal published regulation(EU) 2017/1000, amending Annex XVII in EU REACH regulation and a new restriction toperfluorooctanoic acid(PFOA), its salts and PFOA-related substances. According to the amending regulation, the use of PFOA and its salts at concentrations above 25 parts per billion(ppb)or 1,000 ppb of one or a combination of PFOA-related substance will be prohibited from manufacturing and placing on the market.

According to (EU) 2017/1000, the Annex XVII to regulation (EC) No 1907/2006, the following entry is added:

The name of substance

The requirements of limit

68. Perfluorooctanoic acid(PFOA)

No CAS: 335-67-1
No EC: 206-397-9 and its salts

Any related substance (including its and polymers) having a linear or branched perfluoroheptyl group with the formula C8F17- directive 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 substance are excluded from this designation:

C8F17-X,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 1,000 ppb of one or a combination of PFOA-related substance.

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 theirs health and safety;
(ii)membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment;
(iii)Plasma Nano-coating.
(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) No850/2004;
(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, provide 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 in the production of other firefighting 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;
(b)produced in accordance with point 4(e), provided that, where they are used for training purposes, emissions to the environment are minimized 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 points 3(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(iii)

perfluorooctanoic acid(PFOA) and its salts and related substances, with high frictional resistance, low dielectric capacity, heat resistance, chemical resistance, low surface energy, are widely used in fluoropolymer and fluorine rubber production, fire Foam surfactants, or textile and paper production to provide waterproof, anti-oil, anti-fouling properties.

It is clear when refer to the related-PFOA regulation history. On 14 June, 2013, PFOA was identified as a persistent, bioaccumulative and toxic substance(PBT) , and was included in the candidate List of substances of very high concern(“SVHC”) on the 20 June, 2013 .

On 17 October 2014, Germany and Norway proposed to the EU Chemical Agency (ECHA) that PFOA be added to REACH Annex XVII, to limit the production, market and use of PFOA.

In August and December 2015, the Risk Assessment Commission and committee for Socio-Economic analysis of ECHA have released their views on the proposed changes for limits and management scope . These viewpoints were submitted to European Commission on January 12, 2016. Based on these views, commission considers it necessary to limit the production, use and marketing of PFOA, its salts and related substance, which would have an unacceptable risk to human health and environment.

perfluorooctane sulfonate(PFOS) and its derivatives, one of PFOA-related substance will not be limited by REACH Annex XVII, since it has been regulated by POP (EC) 850/2004.

In addition, PFOA is inevitably produced in the production of perfluorocarbons having a carbon chain length of 6 or less carbon atoms, and this use is also exempted. And there is currently no method for the extraction and analysis of PFOA and its salts and related substances. The analysis method for PFOS CEN / TS 15968: 2010 will be adjusted to apply to PFOA.

The regulation will take into effect since 20thday after the official journal published. After July 4, 2020, the relevant limits of fluorine rubber, fire extinguishing foam and textiles will not be allowed to be sold in the EU market. C&K Testing reminds the business to meet the relevant regulations.


|Further Information:

(EU) 2017/1000

REACH Annex XVII-14/June/2017

EU publishes proposed PFOA limits-12/October/2016

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REACH Annex XVII Testing