Enzyme Sameness Webinar
9 June 2009

The Association of Manufacturers and Formulators of Enzyme Products (AMFEP) is a non-profit European industry association (www.amfep.org), founded in 1977. The Enzyme REACH Consortium (ERC, www.enzymes-reach.org) was established on AMFEP’s initiative with the purpose of facilitating a smooth REACH implementation. ERC members have pre-registered enzyme substances according to AMFEP’s guidance on pre-registration.

The next step towards the formation of enzyme SIEFs is the establishment of sameness of substance.

The ERC is proceeding, on behalf of its members, to facilitating the sameness discussions on enzyme substances.

According to the REACH Guidance on Substance Identification (Section 4.3.2.3), enzyme substances are identified by:

1) the catalytic activity of the enzyme protein (IUBMB nomenclature) and
2) the other constituents from the fermentation.

The ERC proposes to facilitate sameness determination by following the above definition.

Step 1: IUBMB nomenclature

IUBMB nomenclature is defined by the International Union of Biochemistry and Molecular Biology (www.chem.qmul.ac.uk/iubmb/enzyme/index.html). The primary criterion for establishing a SIEF for enzymes is the IUBMB nomenclature. This is in particular because some enzyme entries on EINECS are either too broad or narrow respectively compared to the IUBMB classification. Thus, some of the enzyme pre-SIEFs will have to be merged/split primarily according to IUBMB. To facilitate this process, AMFEP made a list of EINECS-IUBMB correspondences in Annex I of the AMFEP guidance on pre-registration.

Step 2: The other constituents

The ERC policy document on “Safety evaluation of technical enzyme products with regards to the REACH legislation” describes two ways of documenting sameness of the other constituents based upon objective and transparent criteria. ERC will propose each member of a SIEF to adhere to this policy and to use these criteria in order to define sameness in a SIEF.

Please send your questions or comments to the ERC coordinator:

Mr. Youri Skaskevitch
Telephone: +32 (0)2 740 29 62
E-mail: coordinator@enzymes-reach.org

Webinar on enzyme sameness of substance

On 9 June 2009 ERC organised a webinar on the issue of enzyme sameness of substance. All potential REACH registrants of enzyme substances were invited to participate.

Presentations are now available :

1. Introduction
2. Competition law
3. Safety evaluation