Major regulatory aspects on technical enzymes
EU REACH regulation
Enzyme substances included in products destined for technical applications such as detergents, textile processing, biofuels, pulp & paper processing etc., need to be registered under the EU REACH Regulation [Regulation 1907/2006 (for “Registration, Evaluation, and Authorisation of Chemicals”)] before they can be manufactured and/or imported into the EU in a volume above 1 ton per year. The European Chemicals Agency (ECHA) is the implementing authority on an EU level and supervises the registration process.
Activities regarding REACH implementation are discussed and facilitated within the Enzymes REACH Consortium (ERC) created by AMFEP.
Since the third and final registration deadline of May 2018, the majority of enzymes has been registered following the guidance documents developed by the ERC. If an enzyme is in the scope of REACH registration, it should be registered before its tonnage exceeds 1 ton/year.
Please visit website of Enzymes REACH Consortium for the latest versions of relevant tools and guidance documents.
The EU CLP Regulation 1272/2008 (for “Classification, Labelling and Packaging”) adopts the United Nations’ Globally Harmonised System on the classification and labelling of chemicals (GHS) across all European Union countries. The regulation requires companies to appropriately classify, label and package their substances and mixtures before placing them on the market. The CLP Regulation amended the Dangerous Substances Directive (67/548/EEC (DSD)), the Dangerous Preparations Directive (1999/45/EC (DPD)) and Regulation (EC) No 1907/2006 (REACH), and since 1 June 2015, is the only legislation in force in the EU for classification and labelling of substances and mixtures.
Companies should (self) classify and label hazardous substances and mixtures. For certain substances (including several enzymes) classification and labelling should be harmonised throughout the EU to ensure an adequate risk management. This is done through harmonised classification and labelling (CLH). Harmonised classifications are listed in Annex VI to the CLP Regulation and should be applied by all manufacturers, importers or downstream users of such substances and of mixtures containing such substances.
CLP introduces a duty on any manufacturer or importer to notify details of the substances they place on the market to the Classification & Labelling (C&L) Inventory. This is the case for:
- substances subject to REACH registration and placed on the market;
- substances classified as hazardous and placed on the market on their own;
- substances classified as hazardous and placed on the market in a mixture, resulting in that mixture being classified as hazardous.
Notification can be done as a group of importers (e.g. legal entities of the same company), and substances need to be notified within one month from being placed on the market.
As a consequence of Art. 45 of CLP Member States can have an institution, e.g. Poison Center or Product register, to which companies placing on the market mixtures classified as hazardous should notify product details like chemical composition. This information is to be used in the event of emergency health response.
On the 22nd of March 2017, the Commission adopted Regulation (EU) No 2017/542 which implements Art. 45 of CLP on harmonising information related to emergency health response.
The two main elements introduced by the implementing Regulation describe a:
- Harmonised format for submitting information to appointed bodies. A common EU format will gradually replace the current national information requirements. Information to be provided relates to the chemical composition of hazardous mixtures, identity and concentration ranges of ingredients, and the product category according to a harmonised EU Product Categorisation System (PCS).
- Unique formula identifier (UFI). The UFI is a unique code to be printed on the label of the product.
- Importers and downstream users placing hazardous mixtures on the market will be responsible for submitting the required information in the Member States where the mixture is placed on the market. Phased deadlines for the submission of information will apply on 1 January 2019 in a stepwise manner, depending on the intended use of the mixture.
Please see AMFEP’s guidance on Classification and Labelling and Packaging Regulation: https://amfep.org/publications/position-papers-statements/
For more details you can visit this web page: https://poisoncentres.echa.europa.eu/information
Biocidal Product Regulation (BPR)
Enzyme products may contain preservative(s) which may fall under Biocidal Product Regulation (BPR)*. AMFEP set up a consortium for sodium benzoate in 2015, where the members collaborate to get authorisation for a biocidal product containing sodium benzoate (EC 208-534-8) as active substance, when used as “product-type 6: preservatives for products during storage” for enzyme mixtures.
AMFEP also set up a consortium for potassium sorbate in 2017, where the members collaborate to generate the necessary efficacy data for the use of potassium sorbate as a preservative in enzyme products.
AMFEP secretariat is the consortiums’ administration manager. If you have any questions, please contact firstname.lastname@example.org
*: Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products