Document V3Lo3VZo5rKZnM7pkDdeREwRo

Ref. Ares(2023)218982897560 - 27/03/2023 Ref. Ares(2022)3454550 - 05/05/2022 DETERGENT REGULATION Meeting with DG GROW, 4th May 2022 A.I.S.E. A.I.S.E. 2022 - www.aise.eu Reproduction of any part of this content is prohibited TARGETED CONSULTATION Microbial cleaning products Refill and bulk sales Phosphorous-based compounds (P) in professional and industrial detergents and maintenance products General questions 2 A.I.S.E. 2022 - www.aise.eu MICROBIAL CLEANING PRODUCTS What are the types of microbial cleaning products currently on the market? (e.g. for consumer/professional use, based solely on the action of microbes or with a combined action of surfactant + micro-organisms). This is a representative list, though not exhaustive of products with these ingredients inside and outside the EU): Hard surface cleaner/ toilet cleaners Spot and stain remover Drain cleaner Hand dish soap Hand-wash detergents All purpose cleaner Floor cleaner Grease trap maintenance Carpet and upholstery cleaners. In multiple formats including liquid soap, concentrated products (used by dilution), bottles. Used in both consumer and professional settings. (both spray 3 A.I.S.E. 2022 - www.aise.eu MICROBIAL CLEANING PRODUCTS What is the volume of these products in the market? What are the trends (is it a growing or declining market)? A.I.S.E. have no data on the volumes. We could see this as an emerging market. What are the benefits associated with these products? Alternative cleaning technology for current applications - new use of biobased ingredients 4 A.I.S.E. 2022 - www.aise.eu MICROBIAL CLEANING PRODUCTS What are the risks associated with micro-organisms currently used in these products? Micro-organisms used in these products must be non-pathogenic. Importance of quality assurance - eliminating potential contamination (refer to RIVM document Biological cleaning products Biological cleaning products Investigation into the applications and the safety risk). A.I.S.E. will continue to work with companies to ensure risks are evaluated correctly for this new product category with guidance and industry action. 5 A.I.S.E. 2022 - www.aise.eu MICROBIAL CLEANING PRODUCTS Are the current rules under EU regulations sufficient to address the risks associated with the use of the micro-organisms as ingredients in these products? Please explain_______ Detergents are regulated by Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents. The legal definitions in article 2 of the regulation apply. For consumer products, the General Product Safety Directive includes legal requirements to "only place safe products on the market" considering a safe product as GPSD Article 2(b). This is translated into national legislation. For professional products, the Directive 2000/54/EC for biological agents at work, outlines employers' obligations with respect to work involving (or likely to involve) exposure to biological agents and classifies organisms into 4 categories, The safety of professional products (and consumer products) is the responsibility of manufacturers based on Regulation (EU) 2019/1020: market surveillance and compliance of products. It is the basis of forced recalls in the professional sector. In addition, national legislations (for example national rules on GMO use, or Biological occupational safety requirements) must also be considered. Guidelines can support on the details of a framework. It is noted that a Microbial Based Cleaning/Disinfecting Product working by a cleaning process and by biocidal action is regulated by both (the Detergent Regulation and the Biocidal products are regulated by Regulation (EU) No 528/2012). 6 A.I.S.E. 2022 - www.aise.eu MICROBIAL CLEANING PRODUCTS What changes are required for the regulation of these ingredients? A.I.S.E. is willing to engage to discuss legislative changes to the Detergent Regulation to clarify the status of microbial cleaning products. We wish to engage to propose a consumer friendly, language neutral, way to communicate on these ingredients to the consumer/ end users. What would be the impacts of introducing risk management measures in the Detergents Regulation? Default risk management measures, that are not based on a product specific risk assessment are not appropriate. Appropriate safety assessment should be based on user exposure (risk assessment) and not on hazard-based assessment alone. What would be the costs for the industry (one-off and ongoing)? Depends on the changes. A.I.S.E. wishes to discuss amendments to the Detergent Regulation that will address concerns on these products, while also being science based. 7 A.I.S.E. 2022 - www.aise.eu REFILL AND BULK SALE - CONSUMER PRODUCTS Bulk sale: the sale of a bulk product, be it by purchaser, self-service or in a shop counter, by manual means or by an automatic or semiautomatic equipment. "Bulk product: product that is not available to the purchaser prepacked and is just measured or weighed in the shop in the presence of the purchaser" When a product is sold in bulk the shop should provide appropriate packaging (wrap paper, bag, box, bottle) or may allow the purchaser to use their own packaging. Refill sale: the refill in the shop of a reusable packaging. The refill can be done by the purchaser or in a shop counter, manual or automatic or semi-automatic equipment. There is a separate category of refill products which consists in the consumer purchasing a pre-packaged product which is used to refill an existing container (e.g. a spray bottle). This type of sale is not in scope of the document. 8 A.I.S.E. 2022 - www.aise.eu REFILL AND BULK SALE - CONSUMER PRODUCTS The initiative to sell via refill must be made by the entity that is on the label of the product that should take the steps to ensure product safety. The entity that is on the label is responsible to make the full label and any information available to the Retailer as required by the legal frameworks applicable (CLP, Det. Reg. etc.). A.I.S.E. refer to our extensive guidance document outlining key aspects to consider for successful implementation. 9 A.I.S.E. 2022 - www.aise.eu REFILL AND BULK SALE - CONSUMER PRODUCTS Packaging The use of inappropriate bottle/container for the bulk sale of detergents (e.g. of old food or drink containers) must be avoided, in line with legal requirements (Art. 35 (2) CLP, Art. 69 (1) BPR and Directive 87/357/EEC). It is recommended that packaging used in bulk refill sale is empty, clean and dry before having new products decanted into it. Appropriate handling Avoid contact with damaged skin Important not to mix products Keep away from children Consideration for retail staff In general, for products which meet the criteria for classification as "hazardous", a Safety Data Sheet (SDS) needs to be supplied. Usually for consumer products only distributors or retail shops selling the product need to be provided with an SDS. Hygiene practices 10 In case a product needs to be handled (e.g. decanted) by retail staff, they should have access to an SDS and information for safe use. It is key to ensure that retail or maintenance personnel are properly trained to handle the products safely in case of bulk/ refill sale through filling stations. Execution should ensure hygiene/microbial quality across the life cycle of products subject to bulk and refill sale. This may require identifying aspects of the execution that could lead to a hygiene risk (e.g. packaging cleanliness, use of appropriate dilution solvent) and taking preventative measures. A.I.S.E. 2022 - www.aise.eu P USE IN PROFESSIONAL CLEANING & DISINFECTION PRODUCTS The professional cleaning products sector: is responsible for circa 1% of total P discharge into wastewater in Europe has achieved a decrease in the use of phosphorus of 18% since 2014 without legislative restrictions has extensive experience in leading impactful voluntary industry initiatives is diverse and complex in nature with many applications, which would be difficult to consider and describe in their entirety in a restriction. Restrictions may lead to important applications not being considered, and the loss of crucial formulations and applications. Industry position For the reasons cited above, A.I.S.E. does not support a restriction or limit values to be applied to the professional cleaning products sector, but rather proposes for voluntary schemes to further reduce the use of P. 11 A.I.S.E. 2022 - www.aise.eu USE OF PHOSPHATES/PHOSPHONATES IN PROFESSIONAL CLEANING Phosphates and phosphonates essential in professional cleaning and hygiene products: phosphates are multi-functional ingredients with specific applications in healthcare, food beverage and agriculture kitchen and catering, technical cleaning, building care, and industrial laundry essential for optimal cleaning and hygiene performance in the industrial and professional cleaning sector. unique properties include excellent hardness stabilization, good chelating products; better for safety than other acids (nitric acid for example); efficient and essential in cleaning products, good anticorrosion properties - ensuring the durability of materials (e.g. protection of metal surfaces) as well as stabilizers in biocidal products. difficult to substitute with alternative substances, without impacting the cleaning and hygiene performance as well as the sustainability of the products and processes. Substitutes are less effective. 12 A.I.S.E. 2022 - www.aise.eu REDUCTION IN P USE IN PROFESSIONAL CLEANING PRODUCTS SECTOR 14.000,00 13.000,00 12.000,00 11.000,00 10.000,00 9.000,00 8.000,00 7.000,00 6.000,00 13 2014 2018 2020 A.I.S.E. 2022 - www.aise.eu THE IMPACT OF RESTRICTIONS Consequences of restricting P 600 Number of internal A.I.S.E. Survey responses 500 400 300 200 100 0 14 Reformulation Higher cost STPP and other phosphate salts Reauthoirisation under BPR Axis Title Phosphoric acid Other consequences Phosphonates A.I.S.E. 2022 - www.aise.eu THE CONSEQUENCES OF ALTERNATIVES Number of survey responses 180 160 140 120 100 80 60 40 20 0 15 Consequences of alternatives to P MGDA Higher cost More water Bleach Higher temp. Sodium hydroxide Enzymes Other anionic surf. Higher dosage Longer cycle Add. hygiene step Less efficacious Other acid Equipement damage Other process Other A.I.S.E. 2022 - www.aise.eu CRITICAL USES/ APPLICATIONS IN INDUSTRIAL & INSTITUTIONAL SECTOR Detergent products that also fall under the scope of other regulatory frameworks like the Biocidal Product Regulation (BPR) or Medical Devices Regulation (MDR). The essential use of phosphorous for the proper functioning and successful dismantling of nuclear power plants. Use of concentrated products that are diluted before use e.g. in industrial dish and laundry applications, food & beverage sector, is commonplace in the sector and essential for sustainable cleaning, enables significant environmental savings 16 A.I.S.E. 2022 - www.aise.eu P USE IN DETERGENT AND MAINTENANCE PRODUCTS In the consumer hand-dishwasher detergent sector Technically using phosphorous in hand-dishwash does not make sense The size of the market for hand dish washing detergents containing phosphorus is NEGLIGIBLE 17 A.I.S.E. 2022 - www.aise.eu 18 A.I.S.E. 2022 - www.aise.eu