Document JJmaEkOX58Nk6DQrn74v5ea46

Extension of the GRA AMFEP & A.I.S.E. example 13 May 2022 Enzymes are... proteins produced by fermentation. * act as catalysts - make and improve nearly 400 everyday consumer and commercial products (food ahnodusbeehvoelrdagcel,eaanniingm,albinouftureiltsioannadnednteerxgtyilgesentehrraotiuognh).to + readily biodegradable celxahsisbiiftiendofsoprectihfeicenenvviirroonnmmeennttal toxicity - not thoaxviceitayn, reexpceealtlednotsseafteotxiyciptryo,figleeno-tonxoicriitsky,of acute tocxaircciintoygenicity or reproductive and developmental TEAST en a Tr rd 3 1 ay De v Arch $) i | = Lf a -a 3 LX 4 amie) The safety of enzymes + Enzymes are classified as Respiratory Sensitizer Category 1 q == * dDeoscpuimteentthiesdinstarfien:sic hazard, the useof enzymes has been e -- s - No reporting of enzyme allergies to consumers for 50+ years* === e- Onczcyumpeatailolenraglieesx.pFoeswuriencliedaednststohvaevreybleiemniterdepnourmtebderwhoefre exposure control has not been in place. D J em orsAbay ne Ee et mtn 9730 amide) t-eRcEhnAiCcHaleavpaplluiactaitoinoncsoonfdaulcpthead-a(mCyolRaAsPea2n0d15R-M20O1A8). fCoornacllluded ---------- twhoartketrhse,uasneds tohfaetntzhyismecosnacrleussiaofne ctaonbcootvhecroanllseumnezrysmeancdlassesm ." E~' i 7% . Product Stewardship A Derived Minimal Effect Level (DMEL) has been set for | cu..... all enzymes, e.g. in the cleanin&g laundry uses: Eo - 60 ng/m? for workers boi -15 ng/m? 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) - cGounisdaunmceer dporocduumcetnst for risk assessment of enzyme-containing. 8 - [--_-- - oa -- wl SN ee, = Be a ea e ere M7 *)40yearsat thetimeofestablishingtheDMELs wD) Sustainability benefits of enzymes in cleaning products Highly targeted bio-catalysts used in detergents focrobleoturtecrarsetaainndroevmeorvaalll,clwehaintienngespse,rffaobrrimcanacned >5 98pemirlwiaosnhtCoOn,esreCcsucrteodnucpteirownadsuhe (w1o1ctoimmpealcotwieorn)* 4 2,300GWh/year in Euro-Cpoled wash G5 samacov ectonpervan Ln ee 6 30 millon tonne saving due to compaction (on'y 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. 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.