Document B86aaZjVBmNnBLpp0a22re4eX

federal public service HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT Per- and polyfluoroalkyl substances - PFAS DGEM DPPC MRBC Content What and why are PFAS? Chemical identity and uses Human health hazards and risks Environmental hazards and risks How are they regulated? History of regulation EU CSS REACH restrictions Stockholm convention What is BE doing? Planned and ongoing actions CCIEP group PFAS: Per- and Polyfluoroalkyl substances Man-made chemicals Produced since 1950s Defined by Carbon Fluor bond (C-F) One of the strongest chemical bonds "forever chemicals" PTFE (Teflon) PFOS Very large group of substances Very large group of substances Over 4000 substances Several large groups Classically known PFAS (PFOS, PFOA, etc.) Fluorinated polymers Fluoropolymers Side-chain fluorinated polymers Fluorocarbons F-gases ... PFAS use C-F bond is very strong very stable molecules interesting characteristics Stability and thermo resistance (can withstand high temperatures) Electrical wire coating Use in Personal Protection equipment (fire fighting gear) Fire fighting foams Water and grease repellent characteristics Outdoor gear like tents, shoes and raincoats (for example Gore-Tex) Non-stick pots and pans (Tefal) Food contact materials (popcorn bags, pizza boxes, ...) M I I Airconditioning Fire extinguishers 0 i i Heat pumps Refrigeration ONE-OF-A-KIND POLYMERS Fluoropolymers are unique chemical substances used across numerous technologies, industrial processes and everyday applications from the aviation industry to transportation, medical devices and energy production and technical apparel. With a unique set of properties, they are durable, chemically inert and mechanically strong. Fluorpolymers help to keep us safe and enable innovation. SUSTAINABLE BUILDINGS Essential uses? :"II P0 i t 1. .pl t i ll. 0.0 'II i' ki ill r ll l I 1 1.0 0 1. g o I . 1k 10, P 0O .1..1 I" .1i '', ''...." .-. .,,,,,....,-...._ .....,, ,,,,....,..," ...,,, ''''" ."< :#5 ,. AERCrSPACE 4.- '..,.,....,,, c....,' .".,.'''',,4... ,4 .".......kk.....-- .0-0? ,.., ..., ,.... -, ,,'i,,-,k,,,`,,*,,-,-,,,,.`,...,..,"..,...,..,..1:.,..,,.,`, ........,,,,,:..,,,.,,..:,....t ii i i- , * II ix PLASTICS EUROPE Enobling a sustainable future Flucropolyr,Ors Product Group WHY DO WE USE FLUOROPOLYMERS? Ensure , reliability and performance across a variety of sectors Low-risk polymer for human health & environment . Help drive EU industry competitiveness and innovation Critical to numerous technologies enabling the Green Deal, reducing waste and emissions Few, if any, viable alternatives ceesecAL 'Nokomis ) POWER INDUSTRY ENERGY federal public HEALTH, FOOD AND ENVIRON DOGITALISATION FOOD SAFETY MEDICAL USE Uses of fluoropolymers Promoting sustainable and smart mobility through electric vehicles. Extending the lifespen of medical equipment and devices, reducing the need for replacements, risk of failure end cross infections. Enabling a data driven economy though the manufacturing of microprocessors and semi-conductors. Facilitating the Renovation Wave and the construction of energy efficient buildings. Driving innovation and helping decarbonise the aviation industry. Assisting the chemicals industry in preventing corrosion in harsh environments, Ensuring food and pharmaceuticals remain fresh and uncontaminated. Protecting workers in professional protective and high-performance clothing. PFAS Hazards Overarching concern: persistence! Health concerns defined for some PFAS are: Bioaccumulation Endocrine disrupting effects Carcinogenicity Toxicity to reproduction Effects on immune system link with COVID vaccine efficiency! ... Only a few PFAS are extensively studied! Emerging concerns Low-dose effects Non monotonic dose response Mixture effects  Body of knowledge is increasing But still a lot of knowledge gaps! Impossible to fill in all gaps in a reasonable time PFAS tox database Environmental fate and exposure to PFAS C-F bond is extremely persistent in the environment Irreversible environmental contamination Very hard to remove from water, soil and air Widespread use in consumer products (textiles, food contact materials, cosmetics) Landfill leachate Incomplete incineration release of PFAS to atmosphere ... Source: Brase et. al 2021 Environmental fate and exposure to PFAS Many different points of exposure to humans. Figure 1. Overview of exposure sources, pathways and health effects associated with PFASs Possible sources of exposure How can PFAS enter your body? How might PEAS affect your health? Source: HBM4EU Policy brief federal public service HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT House dust Occupational exposure Eli (PFAS manufacture, firefighters, ski waxing, chromium plating...) Home consumer products is Personal care products Breast milk Contaminated drinking water 00( Contaminated food Food consumer products Via inhalation Via dermal absorption (7#;4) Via ingestion Where they can be possibly found? PFAS can be found in consumer products, such as food packaging and cookware; personal care products, such as shampoo, dental floss, nail polish and eye makeup; cleaning products, upholstery, leather, and carpets as well as home improvement products such as paints, varnishes, lubricants and sealants. It can also be found in contaminated drinking water (close to manufacturing afancdiliatiierps,owrtass) toertfroeoadtm(fiesnht, fmaceialitti,efrsu, fitiraenfidghfrtuinigt parnoddumcitlsit,aergygtsr,avineignegtasbitleess el) and vegetable products due to contaminated soil). mmunotoxicity Thyroid disease Increased cholesterol levels Liver damage Kidney and testicular cancer Developmental toxicity Effects on reproduction and fertility  PFAS detected in blood serum in approximately 98% of the population HBM show large portion exceeding the guideline values PFOS and PFOA levels are decreasing Not the case for other PFAS! PFAS contaminated sites Over the years large scale pollution near PFAS production sites have been uncovered US: Dupont and 3M Italy: Miteni Ltd. and Solvay Netherlands: Chemours Belgium: 3M ... Significantly higher PFAS concentrations are found in populations living near such contaminated sites Very high costs associated to remediating the PFAS pollution (very hard due to persistent characteristics) federal public service HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT How are PFAS regulated? History of PFAS policy actions 2006: EU restriction of PFOS (under Dangerous Substance Directive) 2009: PFOS added to the Stockholm Convention on Persistent Organic Pollutants (POP regulation in EU) 2011: PFOA and APFO identified as SVHC + CLP classification 2012: ICCM3 identifies PFAS as emerging policy issue 2016: PFNA identified as Substance of Very High Concern (SVHC) + CLP 2017: PFOA added to the REACH restriction list (Annex XVII) 2017: PFDA identified SVHC + CLP 2019: HFPO-DA (Gen-X) identified SVHC Well know PFAS get regulated lesser known related PFAS replace them! = regrettable substitution 2020: PFOA added to Stockholm Convention 2020: PFBS identified as SVHC 2021: C9-C14 added to the REACH restriction list (enters into force in 2023) 2023: PFHxS and related substances will be added to the Stockholm Convention 16 2020: Chemical Strategy for Sustainability (CSS) Published in October 2020 Part of the EU Green Deal Several actions on chemicals envisaged: Review of REACH and CLP Take action on the "cocktail effect" ... Phase out of all PFAS in the EU, except for "essential uses" 17 CSS: EU PFAS strategy Goal: minimization of exposure of humans and environment to PFAS, taking into account the complete life-cycle of these substances Proposed actions: Take action on PFAS as a group Phasing out all PFAS, except for essential uses, until safer and sustainably alternatives are available Development of limit values for all relevant EU legislation Take action on effective enforcement (Bio)monitoring, researching alternatives, developing new analytical methods, etc. PFAS SWD 18 REACH restrictions REACH = Registration, Evaluation, Authorisation and Restriction of CHemical substances Registration of all chemical substances put on the market in the EU at more then 1 ton/year Evaluation of registration dossiers and substances Authorisation of chemicals which are prohibited in the EU, except when authorisations are granted Restrictions, which are a broader tool to ban or limit the marketing/use or formulation of substances On restrictions REACH restrictions: restricting the manufacturing, placing on the market or use of a substance on its own, in a mixture or in an article When there is an unacceptable risk to human health and/or the Environment Standard process: Preparation of a restriction dossier (Annex XV dossier) Public Consultations on the dossier Development of scientific opinions of the Risk Assessment Committee (RAC) and the Socio-Economic Committee (SEAC) After finalization of the Annex XV and the Opinions EU Commission prepares a restriction entry for REACH (legal text) Proposal will be discussed and voted in the REACH Committee by Member States Starting the restriction process Notification of intention to submit a restriction proposal Registry of Intentions Preparing the restriction dossier Submission and conformity check 411) federal public service HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT | Consultation on the restriction report Consultation on SEAC's draft opinion Advice from the Forum 0.0 IL7 Alr RAC's opinion SEAC's opinion Opinion development Commission decision on restriction Complying with restriction Enforcing the restriction REACH PFAS restrictions Several PFAS restrictions in the pipeline Already in force: PFOS and PFOA (so called C8 PFAS) Moved to Stockholm convention (POP) To be entered into force C9-C14 PFCAs To be decided PFHxA and related substances PFHxS and related substances (will go to POP) In development PFAS in fire fighting foams Proposal on the way Universal PFAS restriction Universal PFAS restriction proposal REACH restriction proposal to be submitted by 4 Member States (NL, DE, SE, DK) and NO Focus on the entire group of PFAS "Substances that contain at least one aliphatic -CF2- or -CF3 element". Persistence as main common concern Only "essential" uses can continue Proposal planned to be published in January 2023 Restriction entering into force: predicted for 2025 But probably later! 24 CF3R R'CF2R'' Stockholm Convention International Convention on Persistent Organic Pollutants Implemented in the EU under the POP Regulation PFAS under this convention: PFOA and related substances PFOS and related substances PFAS to be included: PFHxS and related substances C9-C20 PFCAs Obligations for members: Provide data on stocks Ensure proper waste management Report on inspections ... What is Belgium doing? federal public service 26 HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT Actions on regional level Walloon region Monitoring projects BIODIEN: PFAS in surface water and groundwater CARIBOUH: PFAS in sewage sludge Flemish region PFAS action plan Monitoring projects and research initiatives Human biomonitoring Since 2021: many new projects Federal level actions on PFAS DGEM Substance evaluations of PFAS substances under REACH Belgian Competent Authority of REACH: Belgian vote for authorisation and restriction dossiers NAPED: research activities on PFAS substances envisaged under this plan Follow-up of the CSS and the REACH and CLP revisions Piloting the CCIEP group on PFAS (see next slides) Inspection campaigns on PFAS Belgian Builds Back Circular Substitution project on PFAS To be developed by FOD Economie Study on PFAS in textiles With focus on PFAS in home textiles DG APF BE position on EU Food Law actions and Food Contact Materials Projects related to PFAS in food (PERFOOD and FLUOREX) Other EU and international PFAS related policy actions Sector specific Food Contact Materials (FCM) Plant Protection Products (PPP) Water Drinking water Directive (DWD) Groundwater Directive (GWD) Water Framework Directive (WFD) ... Product policy Ecolabel Sustainable Product Initiative (SPI) Food EFSA opinion Food contaminants regulation Industrial Emissions Directive (IED) BAT E-PRTR Waste Soil International PIC OECD PFC group OSPAR SAICM Research Horizon Europe ... Competences in Belgium are divided! 33 CCIEP: Coordination Committee International Environment Policy Belgium competences regarding environment are distributed between the different authorities Regional: drinking water, soil, environmental permits, ... Federal: product policy, food safety, ... Need for coordination between authorities for EU and international policy actions on environment 1995: creation of the CCIEP Created in line with the cooperation agreement between the different authorities Existing of working groups responsible for specific environment related topics For example: CCIEP-Chemicals group 34 2019: Creation of the "short-chain" PFAS working group EU and International policy actions shift from well known long-chain PFAS (PFOA and PFOS) to lesser known short-chain PFAS (PFHxA, PFBS, etc.) Focus on "grouping approach" to tackle the large group of substances Arrow-head approach: target degradation product of large group of substances For example: PFHxA restriction process under REACH: group of substances with PFHxA as degradation product Resulting in a lot of different uses being tackled in risk management measures like restrictions Need for coordinated information gathering and exchange of information between Belgium authorities to follow these policy actions Resulted in the creation of a CCIEP short-chain PFAS working group As a subgroup of the CCIEP-Chemicals working group To share and collect data on short-chain PFAS in Belgium 35 Renewal and extension of the CCIEP mandate May 2021: Historical pollution of PFOS near a production site in Zwijndrecht (Antwerp) gets media attention Results in political actions: Federal: Joint-Interministerial Conference on Environment and Health (JICEH) of July 8 2021, which requested to: Extend and expand on the mandate of the short-chain PFAS CCIEP working group To inform and optimize different actions being taken in BE Act as national expert body including all relevant authorities in order to share and collect PFAS related data 36 CCIEP PFAS Working Group New mandate negotiated and finalized in December 2021 includes: Building of a BE databank on PFAS Exchange of information between authorities to contribute to international actions (REACH restrictions, POPs, etc.) Update the existing PFAS report Expand from short-chain to all PFAS Adding current challenges and perspectives Exchange of information with other groups to enhance PFAS policy actions Expansion of the composition adding health competences 37 CCIEP PFAS Working Group - current and planned outcomes Outcomes: BE comments submitted to the Public Consultation of the PFAS in AFFF restriction proposal Info sharing of projects and policy actions via CCIEP report Cooperation between the regions on mapping exercises Discussions on harmonizing standard levels of PFAS over the different regions Upcoming: Providing input into the General PFAS restriction Further providing data into the AFFF restriction proposal Looking into drafting a PFAS AOB point for the ENVI Council Conclusions Etc. Conclusion federal public service HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT PFAS Challenges Large amount of substances Impossible to have complete toxicological profile of all PFAS Impossible to have regulatory action on substance-by-substance basis Large amount of uses Strongly imbedded into current society Hard to substitute due to advantageous characteristics Medical uses, green technologies, etc. Persistent characteristics Don't break down + Very hard to remove from environment = concentrations will keep rising irreversibly Even incineration has not been proven to completely break down the C-F bond Perspectives Large number of substances Act on PFAS as a group REACH restrictions and Stockholm Convention Prevent need for substance-by-substance analysis Prevent need for in depth toxicological analysis of all PFAS grouping based on common hazard persistence Keep expanding the PFAS knowledge base (PFAS tox and PubChem database) Large number of uses Ensure data flow throughout the supply chain Look at concepts like essential use Look into alternatives and Safe and Sustainable by Design concepts Persistent characteristics Innovation on destruction and remediation techniques Look into concepts like extended producer responsibility federal public service HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT Thank you for your attention! 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