What is a restriction?
The Restriction procedure allows the management of those hazards which are not adequately evaluated by specific dispositions of the REACH Regulation. Restriction proposals may concern different things, such as manufacturing conditions, use, placing on the market, or specific prohibitions.
These proposals are suggested by member states or ECHA following requests by the Commission, under the form of dossiers, and are approved as definitive by the Commission.
What changes does this new regulation bring to REACH Annex XVII?
Regulation EU 2017/1000 introduces restriction number 68 to Annex XVII of REACH. This regulation comes into force starting from July 4th 2017, while the restriction itself comes into force starting from July 4th 2020.
This new restriction concerns perfluorooctanoic acid (“PFOA”) (CAS: 335-67-1; EC: 206-397-9), its salts, and any related substance (including its salts and polymers) having, as one of the structural elements, a linear or branched perfluorooctyl group with the formula C8F17-, or a linear or branched perfluoroheptyl group with the formula C7F15- directly attached to another carbon atom.
The following substances are excluded:
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).
Restriction 68 specifies that PFOA:
- “Shall not be manufactured, or placed on the market as substances on their own from 4 July 2020”, and
- “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 1000 ppb of one or a combination of PFOA-related substances”.
This restriction gives further exceptions and information regarding its coming into force, which can be read directly from Reg. 2017/1000.
For further information regarding Reg. 2017/1000 and the new restriction added to Annex XVII, follow this link