On December 9, 2021, the European Commission for Socio-Economic Analysis (SEAC) adopted a final opinion on the German proposal to restrict perfluorohexanoic acid (PFHxA) and its salts and related substances.
Previously, the Risk Assessment Committee (RAC) issued an opinion in June 2021, requiring the restriction of PFHxA and its salts and related substances.
The opinions of the two committees will help the European Commission to make corresponding decisions. After receiving the opinions of the two committees, the European Commission will usually develop a draft document on the revision of the REACH regulation within three months. The draft document After the adoption, the control of PFHxA and its salts and related substances will be officially included in the control of REACH regulations.
The proposed control requirements for PFHxA and its salts and related substances are as follows:
Substance information
Perfluorohexanoic acid (PFHxA) and its salts and related substances:
(A) Compounds with a linear or branched C5F11- perfluoropentyl group linked to a carbon atom;
(B) It has a linear or branched C6F13-perfluorohexyl group.
The following substances are not included:
(A) C6F14;
(B) C6F13-C(= O)OH, C6F13-C(= O)OX' or C6F13-CF2-X' (where X'=any group, including salt);
(C) Any substance that has a perfluoroalkyl C6F13- directly attached to the sulfur atom.
Uses: paper and cardboard (food contact materials), textiles (such as personal protective equipment), home textiles and clothing, and fire-fighting foam, etc.
The main control requirements of the REACH restriction proposal: the substance itself must not be manufactured or put on the market; the PFHxA and its salt content in the composition, mixture, and articles of other substances is less than 25ppb, and the sum of PFHxA related substances is less than 1000ppb (note that this control requirement should be revised by REACH regulations The official document of the instruction shall prevail).
PFHxA and its salts and related substances belong to a class of perfluorinated and polyfluoroalkyl compounds (PFAS). PFAS has persistence, long-distance migration, toxicity and bioaccumulation, and is currently used in many animals worldwide And human blood samples have detected the presence of perfluorinated compounds. The hazards of perfluorinated compounds to humans and the environment have aroused widespread concern in relevant countries and international organizations. More and more perfluorinated compounds have been included or will soon be included in the control of laws and regulations. Among them, substances that have been included in regulatory control include PFOA, PFOS, C9-C14 PFCAs, etc.
So what are PFAS, C9-C14 PFCAs, PFOA, PFOS, PFHxS and other perfluorinated substances?
PFAS
Material information: perfluoro and polyfluoroalkyl compounds
Main control requirements: US TPCH ("Model Regulations on the Control of Toxic Substances in Packaging Materials") requires that it be prohibited;
The Netherlands is working with Denmark, Germany, Norway, and Sweden to develop a European proposal to ban PFAS. The proposal will focus on all PFAS substances to prevent one PFAS from being replaced by another.
C9-C14 PFCAs
Material information: C9-C14 perfluorocarboxylic acids (C9-C14 PFCAs) and their salts and related substances.
(ii) Salts of C9-C14 perfluorocarboxylic acid;
(iii) C9-C14 perfluorocarboxylic acid related substances, which have a perfluorocarbon which is not directly connected to another carbon atom and the formula is CnF2n+1-(n = 8,9,10,11,12,13 or 14) Group, including its salts and any combination thereof.
The following substances are not C9-C14 perfluorocarboxylic acid related substances:
-CnF2n+1 -X, where X=F, Cl, or Br, and n=8,9,10,11,12,13 or 14, including any combination thereof.
-CnF2n+1 -COOX', where n>13 and X'=any group, including salts.
The main control requirements of REACH Restrictions: After February 25, 2023, such substances shall not be manufactured or placed on the EU market; after February 25, 2023, the content of C9-C14 PFCAs and their salts in substances, mixtures or articles shall be less than or equal to 0.025mg /kg; C9-C14 PFCAs related substances in substances, mixtures or articles individually or in total ≤260mg/kg.
PFOA
Substance information: Perfluorooctanoic acid (PFOA) and its salts and related substances include:
(i) Perfluorooctanoic acid, including branched isomers;
(ii) Salts of perfluorooctanoic acid;
(iii) As far as the Convention is concerned, PFOA-related substances refer to any substance that can be decomposed to produce PFOA, including any carbon chain structure containing branched or straight chain perfluoroheptyl groups and having (C7F15)C as a structural element. One substance (including salts and polymers).
The following substances are not PFOA related substances:
(i) C8F17-X, X = F, Cl, Br;
(ii) Perfluoropolymer with CF3[CF2]n-R' structure, where R'can be any functional group, n>16;
(iii) Perfluorocarboxylic acids containing 8 or more carbon atoms (including their salts, esters, halides and acid anhydrides);
(iv) Perfluoroalkyl sulfonic acid and perfluorophosphonic acid (including their salts, esters, halides and acid anhydrides) containing 9 or more carbon atoms;
(v) Perfluorooctane sulfonic acid and its derivatives listed in this annex.
EU POPs main control requirements: PFOA and its salt content in substances, mixtures or articles is less than or equal to 0.025mg/kg; PFOA-related substances in substances, mixtures or articles are single item or total ≤1mg/kg.
PFOS
Since 2009, perfluorooctane sulfonic acid and its derivatives (PFOS) have been included in the international "Stockholm Convention." Contracting parties should take measures to eliminate this substance. National regulations). The European Union included PFOS in the European Union's POPs regulations in 2010, and PFOS and its derivatives have also been regulated in the European Union for more than ten years.
Material information: PFOS and its derivatives C8F17SO2X (X = OH, salts (O-M+), halides, amides and other derivatives, including polymers).
EU POPs main control requirements: substances/mixtures ≤10ppm, articles ＜1000ppm, textiles or coated materials ＜1ug/m2.
PFHxS
PFHxS and its salts have been included in the list of SVHC candidate substances on July 7, 2017. Norway has put forward a proposal to control PFHxS and its salts and related substances in the REACH regulation. On June 17, 2020, the European Union announced that the Socio-Economic Analysis Committee (SEAC) supports this proposal. The proposal on the restriction of PFHxS and its salts and related substances has been adopted by the European Commission, and no resolution has been officially issued yet. Once the relevant resolution is issued, the restriction on such substances will be officially included in the REACH Regulation Restrictions. In addition, such substances are also being considered for joining the "Stockholm Convention." If they are joined, they need to be eliminated globally.
Substance information: Perfluorohexyl sulfonic acid (PFHxS) (branched and straight chain) and its salts and related substances
a. Perfluorohexane sulfonic acid has a structure of C6F13SO3H, and salts and any combination thereof; b. Any substance with a perfluoroalkyl group C6F13- directly connected to a sulfur atom.
The main control requirements of the REACH restriction proposal: the substance itself shall not be manufactured or put on the market; the PFHxS and its salt content in the composition, mixture, and articles of other substances is less than 25ppb, and the sum of PFHxS related substances is less than 1000ppb (note that this control requirement should be revised by REACH regulations The official document of the instruction shall prevail).
Reminder
As more and more perfluorinated substances are included in regulatory control, law enforcement agencies have also increased the enforcement of perfluorinated substances. ZRLK recommends that relevant companies combine the control of laws and regulations to investigate the compliance of perfluorinated substances in products as soon as possible. To ensure that products put on the market meet the regulatory requirements of laws and regulations, and to avoid economic losses caused by violations of regulations after the products are put on the market.
