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Cellulose ethers not in scope of REACH
The European Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation, commonly referred to as REACH, places an obligation on European manufacturers and importers of substances to register the substances in order to continue production in or import into the European market.
Cellulose ethers are polymers derived by chemical modification of the natural polymer cellulose that is obtained from renewable botanical sources.
Cellulose pulp is specifically exempted from the requirements of registration defined in Article 2(7)(a) and is included in the current Annex IV (Exemptions from the obligation to register in accordance with Article 2(7)(a)).
Naturally occurring polymers fall under the definition of polymers contained in REACH (Article 3(5)), and being naturally occurring substances, they are considered to qualify for the exemption of registration as in the current version of Annex V paragraph 8. A manufacturer or importer of a naturally occurring polymer is exempted from the obligation to register the monomer substances or any other substances, provided that the polymer fulfils the definition of a naturally occurring substance and that the polymer has not been chemically modified and does not meet the criteria for classification as dangerous in accordance to Directive 67/548/EEC (see Article 2(7) (b) and Annex V(8)).
When natural cellulose is chemically modified, the resultant cellulose ether substance still meets the definition of a polymer (Article 3(5)) and hence is exempted from the REACH registration requirements (Article 2(9)). [The monomers used in manufacturing the cellulose ether may be subject to registration under Article 6(3) unless they are exempted under Annex V(8).]. The cellulose ethers manufactured by members of the European Cellulose Ethers Industry Association Sector group of Cefic (European Chemical Industry Council) all meet these criteria, and so are exempted from the REACH registration requirements. However, as noted above the monomers used may be subject to registration under Article 6(3).
This position is further supported since monomers that meet the definition of a naturally occurring substance and any other naturally occurring substances identified as building blocks of the polymers do not need to be registered, unless they meet the criteria for classification as dangerous in accordance to Directive 67/548/EEC (see Article 2(7)(b) and Annex V(8)) or they have been chemically modified. In the case of cellulose ethers, the “monomer” is in fact the naturally-occurring anhydro glucose units that constitute the natural polymer cellulose and which are thus specifically exempted from the requirements of registration (Annex IV).
However, it is recognised that the substances used to chemically modify the natural cellulose must themselves be considered for registration under REACH (whether as substances, monomers (since they are repeating units on the cellulose backbone) or intermediates), either by their European producer, their European importer or the appointed Only Representative of a non-European producer. Members of the European Cellulose Ethers Industry Association Sector group will thus be determining the appropriate registration status of these, and where the substances are purchased raw materials such requests will be made to their suppliers.
The European Cellulose Ethers Industry Association Sector group therefore will not be submitting registration dossiers to the REACH Agency for their finished Cellulose Ethers.
(also available as pdf version in several languages see publications)
The Cellulose Ethers Association is a Sector Group of Cefic. It is a non-profit organisation representing major producers of cellulose ethers in Europe.