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Technical enzymes - regulatory aspects

REACH LEGISLATION

Enzymes used in such applications such as laundry, detergents, textile, paper and board (“technical enzymes”) - and placed on, manufactured in or imported into the EU market in quantities above 1 metric ton per year per legal entity- must be registered under the EU REACH Regulation (Regulation 1907/2006 (for “Registration, Evaluation, and Authorisation of Chemicals”). The European Chemicals Authority (ECHA), created by the very same text, supervises the registration process.

Depending on the quantities placed on the EU market and on the classification of the enzyme, different registration deadlines apply. Existing (or, so-called phase-in) substances (and thus, including many but not all enzymes) benefit from extended registration deadlines if they have been pre-registered before 01 December 2008. The principle is that the higher the tonnage is, the earlier the registration deadline is:

  • 30 November 2010 for enzymes substances placed on the EU market in quantities equal or above 1000 metric ton per year, or are Category 1 and 2 CMRs, or are Substances classified with the risk phrase R50/53 (that is, substances classified as very toxic to aquatic organisms which may cause long-term adverse effects in the aquatic environment), if they are manufactured or imported in volumes of 100 tons or more per manufacturer/importer per year;
  • 31 May 2013 for substances enzymes placed on the EU market in quantities equal or above 100 metric ton per year; and finally
  • 31 May 2018 for substances enzymes placed on the EU market in quantities equal or above 1 metric ton per year.

The pre-registration phase has officially ended on 1 December 2008. Yet, if after this date, a phase-in substance is manufactured or placed on the EU market in quantities exceeding 1 metric ton per year for the first time, it is still possible to submit a late pre-registration to ECHA. In that case, the substance could benefit from an extended registration period described above while being allowed to be commercialised in the EU. Such a ‘late pre-registration’ needs to take place within 6 months of the first manufacture or import of the substance in quantities of 1 ton or more per year, and no later than 12 months before the relevant phase-in registration deadline.

In all other cases, the manufacturer or importer should register its substance immediately before placing the product on the EU market.

SEVEN ENZYMES REGISTERED AS OF 31 MAY 2013

As of the second registration deadline of May 2013 (substances manufactured or imported in quantities of 100 to 1000 metric tonnes per year), seven enzymes have been registered. These are glucoamylase, subtilisin, cellulase, mannanase, alpha-amylase, lipase and laccase. The biggest wave of registrations is expected to happen in 2018 when lower tonnage bands (1-100 metric tonnes per year) will have to be registered by the third and final deadline of 31 May 2018.

See also: Enzymes REACH Consortium

CLP LEGISLATION

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. It complements the EU REACH Regulation and will eventually replace the current system contained in the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC). There is a transition period until 2015.The CLP is also applicable to food and feed enzymes, except when - in the finished state – they are intended for the final user.http://echa.europa.eu/web/guest/support/faqs/clp-frequently-asked-questions.

The CLP Regulation is already applicable to substances that are placed on the market since 1 December 2010. It is not mandatory to use the CLP classification system to classify chemical mixtures (preparations) until 1 June 2015. There are certain limited circumstances where these transitional arrangements for substances and preparations/mixtures can be extended: the re-labelling and re-packaging of substances and mixtures which are already labelled and packaged and in the supply chain (‘on the shelves’) on the above compliance dates may be postponed until 1 December 2012 and 1 June 2017 respectively.

For certain substances the classification is harmonised and made obligatory. Currently this is the case for 17 enzymes.

CLP introduces a new 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.

See also: Classification Labelling and Packaging Regulation

BIOCIDAL PRODUCT REGULATION

Consortium  for authorisation of a biocidal product containing sodium benzoate under Biocidal Product Regulation, for “product-type 6: preservatives for products during storage” when used for enzyme mixtures.

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 (herein after Biocidal Product) containining sodium benzoate (EC 208-534-8) as active substance, when Biocidal Product is used as “product-type 6: preservatives for products during storage” for enzyme mixtures. 

Amfep secretariat is a consortium administration manager. If you have any questions, please contact amfep@kellencompany.com

*: 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