Brussels,12 September 2023
EuropaBio welcomes the Revision of the Detergents Regulation. This is a positive development in supporting access to market for innovative products, in line with the EU Chemicals Strategy for Sustainability and overall EU Green Deal objectives for sustainability.
We support revision of the following points in annex II on microbial based cleaning products (MBCPs) to ensure that requirements are risk-based considering the safety, efficacy, and sustainability profile of products:
− Annex II, point 1:
o Microorganisms should be fully identifiable, but it is not necessary to specify the American Type Culture Collection (ATCC) when there are several other well-established culture collections.
o For identification purposes, the requirement for 16s ribosomal DNA should be replaced with a more reliable identification method such as Whole Genome Sequencing.
o The microorganisms used should be safe, even if not present on the Risk Group I or QPS list.
− Annex II, point 2: We fully agree to the exclusion list of pathogens in the final product but the reference to strain in the text is incorrect and should be deleted. The final product shall be free of pathogenic microorganisms.
− Annex II, point 3: The primary focus should be to assess the safety of genetically modified microorganisms deliberately released into the environment, rather than completely excluding their use in detergents. The text should be amended to include a reference to Directive 2001/18/EC on deliberate release of genetically modified microorganisms into the environment which provides guidance on the preparation of an environmental risk assessment (ERA) and on the establishment of an environmental monitoring plan.
− Annex II, point 6:
o There should not be an additional requirement for minimum shelf life for MBCPs compared to conventional detergents. This requirement should be amended to include that the product is stable for the declared period of shelf life.
o Delete the requirement of <10% microbial count decrease. The key requirement should be that the product is stable for the declared period of shelf life.
− Annex II, point 7: Animal tests should only be performed as a last resort, particularly where other tests can provide information to address concerns. The text should be amended to include this nuance and prioritize other tests such as immune tests or particle size distribution measurements.
− Annex II, point 9 and 11: Producers should be able to perform tests related to functionality and marketing claims themselves, rather than requiring an external lab. This requirement should be removed.
− Annex V, point 6(a): Further clarification and guidance is needed for the point on ‘surfaces in contact with food’. This point shall be amended to refer to “instructions or special precautions, where relevant” to address safety concerns.