Document pmZ5e8GoovO3EbvmxGOOJY83j

Ref. Ares(2023)2188876 - 27/03/2023 Extension of the GRA AMFEP & A.I.S.E. example 13 May 2022 Enzymes are... biological proteins produced by fermentation. act as catalysts - make and improve nearly 400 everyday consumer and commercial products (food and beverage, animal nutrition and textiles through to household cleaning, biofuels and energy generation). readily biodegradable exhibit no specific environmental toxicity - not classified for the environment have an excellent safety profile - no risk of acute toxicity, repeat dose toxicity, genotoxicity, carcinogenicity or reproductive and developmental toxicity The safety of enzymes Enzymes are classified as Respiratory Sensitizer Category 1 Despite this intrinsic hazard, the use of enzymes has been documented safe: - No reporting of enzyme allergies to consumers for 50+ years* - Occupational exposure leads to very limited number of enzyme allergies. Few incidents have been reported where exposure control has not been in place. - REACH evaluation conducted (CoRAP and RMOA) for all technical applications of alpha-amylase 2015-2018. Concluded that the uses of enzymes are safe to both consumers and workers, and that this conclusion can cover all enzyme classes. *) Prevalence of sensitization in population very rare, 0.126% in 1977-2010 Product Stewardship A Derived Minimal Effect Level (DMEL) has been set for all enzymes, e.g. in the cleaning & laundry uses: - 60 ng/m3 for workers - 15 ng/m3 for consumers Based on published clinical studies, and data generated for decades* Focus on product design, low-dusting and non-volatile Development of publicly available guidance material: - Comprehensive guidance document - Webinars introducing specific subjects - Posters for professional workers (17 languages) - Guidance document for risk assessment of enzyme-containing consumer products *) 40 years at the time of establishing the DMELs Sustainability benefits of enzymes in cleaning products Highly targeted bio-catalysts used in detergents for better stain removal, whiteness, fabric and colour care and overall cleaning performance Significant environmental benefits Washing at low temperatures Innovating compact products Alternative technology to phosphates Readily biodegradable- no environmental impact GRA extension and enzymes The issue: The Chemicals Strategy for Sustainability (CSS) - Proposal to extend the current GRA to uses by professionals and to additional chemicals e.g. those affecting the respiratory system. Enzymes are classified as Respiratory Sensitizers Category 1 under the CLP Regulation. Our view: It is a far reaching extension of the GRA, based only on the intrinsic properties of substances, without consideration of risk assessment and proven safe use a blanket ban on these ingredients simply due to their hazard would have a huge impact on the enzyme industry and its downstream users (the detergent industry) - depriving them of important environmental, societal and technological benefits. The sector would need a workable procedure with a meaningful derogation process to be designed and implemented. In conclusion Enzymes: a successful example - ahead of its time (1960s) - of innovative ingredients in cleaning products, with wide-ranging functionalities and significant sustainability benefits Opportunity: Enzymes - enablers for multiple sectors to become aligned with EU sustainability policy ambitions: Green Deal, EU Taxonomy, CSS, Farm to Fork, Zero Pollution, ESPR Risk: if GRA is extended to include respiratory sensitizers used in consumer (and professional) uses: Sustainability benefits will be lost for the Cleaning sector - after decades of safe and sustainable performance Leaves the sector with no other sustainable alternatives for their products, thereby impacting consumers' demands. Our Ask: Carefully assess the demonstrated safe use and sustainability benefits of substances, such as enzymes, prior to inclusion in the scope of the GRA.