For a more in-depth understanding of the issues surrounding fluoropolymers, see here for a list of regularly used terminology.
The European Chemicals Agency (ECHA) is a European Union regulatory agency responsible for implementing and administering chemicals legislation. ECHA provides guidance and assistance to organizations with regards to chemical legislation compliance, advances the safe use of chemicals, provides information about chemicals, and highlights and addresses chemicals of concern. ECHA is also responsible for the management of the technical and administrative aspects of a variety of legislative frameworks, including the REACH Regulation..
At present the European Union does not have a definition of “essential use” (nor of “non-essential use”) and the concept is not legally enshrined within the EU. As such the REACH restriction process does not accommodate for the regulation of substances on the basis of essential use.
may meet the REACH definition to be considered persistent but are not mobile in the environment. Fluoropolymers have a negligible solubility and have been demonstrated to have no systemic toxicity. In our opinion, persistence in the environment does not equate to toxicity, bioaccumulation and mobility.
Fluoroplastics and fluoroelastomers (rubbers) are two important categories of fluoropolymers. Both subsets are based on the same monomers and are structurally similar. Their main difference is the higher elasticity of fluoroelastomers, achieved through chemical cross-linking. In a fluoroplastic, hydrogen atoms are replaced with fluorine atoms, giving them the unique properties associated with fluoropolymers. A fluoroelastomer is a fluorocarbon based synthetic rubber with high temperature and chemical resistance properties.
‘Persistency’ is a technical term and defined based on very specific results of specific tests. In a lot of cases persistency and durability are the other side of the same coin. Automotive, aerospace and construction applications frequently require more than 10 years durability in the application.
Fluoropolymers may meet the REACH definition to be considered persistent but are not mobile in the environment. Fluoropolymers have a negligible solubility and have been demonstrated to have no systemic toxicity. In our opinion, persistence in the environment does not equate to toxicity, bioaccumulation and mobility.
Per- and polyfluoroalkyl substances (PFAS) are a vast and diverse group of chemical compounds consisting of approximately 4,700 individual substances. Despite their chemical structure fluoropolymers are different to other PFAS and have specific toxicological and environmental profiles.
REACH is the European Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force in 2007, replacing the former legislative framework for chemicals in the EU. It set the legal framework to manufacture, place on the market (including imports) or use a substance within the EU internal market.
Restrictions are normally used to limit or ban the manufacture, placing on the market (including imports) or use of a substance, but can impose any relevant condition, such as requiring technical measures or specific labels. A restriction may apply to any substance on its own, in a mixture or in an article, including those that do not require registration, for example, substances manufactured or imported below one tonne per year or certain polymers.