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
|Our Services:
REACH Annex XVII Testing