PFAS Regulation 2019/1137: Fluorinated Substances for Forever-Chemical-Free Products
Ensure compliance with the PFAS Regulation (EU) 2019/1137. Textiles, food packaging, and cookware require conformity analysis to commercialize in the European Union without restrictions.
µg/kg
Regulated concentration thresholds by category
Decades
PFAS persistence in the environment
Textiles + Packaging
Sectors with the strictest restrictions
What is the PFAS Regulation (EU) 2019/1137?
The PFAS Regulation covers per- and polyfluoroalkyl substances, popularly known as "forever chemicals" due to their extreme persistence in the environment and the human body for decades.
The regulation restricts the presence of PFAS in waterproof textiles, food packaging, non-stick cookware, and numerous consumer products, establishing maximum concentration thresholds according to product category and intended use.
Without laboratory analysis confirming PFAS levels below the regulated thresholds, no product within its scope can be commercialized on the European market.
Who must comply with PFAS Regulation 2019/1137?
All economic operators in the supply chain of products with potential PFAS content have obligations under this regulation.
Textile manufacturers
Analyze waterproof and breathable coatings, replace PFAS-based treatments, and document the chemical composition of fabrics.
Packaging producers
Verify the absence of PFAS in baking paper, fast food packaging, and materials in direct contact with food.
Cookware manufacturers
Certify pans, molds, and non-stick utensils as PFAS-free or within permitted thresholds by category.
Importers and distributors
Require conformity documentation from non-EU suppliers before introducing products into the European market.
Benefits of PFAS compliance
Obtaining PFAS conformity certification delivers significant competitive, legal, and reputational advantages in the European market.
EU single market access
Commercialize freely across 27 EU Member States without restrictions. PFAS conformity removes entry barriers.
Legal and reputational protection
Conformity documentation reduces civil liability for health damages and protects brand reputation.
Competitive differentiation
Forever-chemical-free products attract health-conscious consumers and demanding major retailers.
Regulatory anticipation
Getting ahead of stricter future restrictions reduces costs of urgent reformulation and product withdrawal risk.
PFAS compliance process step by step
The path from composition analysis to the conformity declaration follows clearly defined stages in European standards.
Mapping materials and suppliers
Identify all components, coatings, and chemical treatments potentially containing PFAS in the supply chain.
Accredited laboratory analysis
Quantify the presence of PFAS substances in the final product through independent certified laboratory testing.
Comparison against regulated thresholds
Compare results with maximum concentration limits established for each product category and intended use.
Substitution of non-compliant materials
Reformulate with fluorine-free alternatives when thresholds are exceeded, validating equivalent technical performance.
Conformity declaration
Document final composition, test results, and issue a conformity declaration before commercializing in the EU.
Frequently asked questions — PFAS Regulation 2019/1137
What is the PFAS Regulation (EU) 2019/1137?
The PFAS Regulation covers per- and polyfluoroalkyl substances, known as "forever chemicals" due to their extreme persistence in the environment and the human body. It restricts their use in textiles, food packaging, non-stick cookware, and numerous consumer products commercialized in the European Union.
What products are affected by the PFAS restriction?
Waterproof and breathable textiles (outdoor clothing, carpets), fast food packaging and baking paper, non-stick pans and cookware, firefighting foams, cosmetics, industrial cleaning products, and electronic components. Any item containing PFAS above established thresholds requires substitution or restricted use.
Why are they called "forever chemicals"?
PFAS contain extremely stable carbon-fluorine bonds that do not naturally degrade in the environment for decades or centuries. They accumulate in water, soil, and living organisms, including the human body, raising concerns about long-term health effects such as hormonal and liver disruption.
What are the permitted concentration limits?
Thresholds vary by PFAS category and product type, established in micrograms per kilogram of material. Food packaging and children's textiles have stricter limits than industrial applications. It is recommended to consult the specific annex applicable to each product category before commercializing.
How is compliance with the PFAS Regulation demonstrated?
Through accredited laboratory analysis quantifying the presence of PFAS in the final product, documentation of the chemical composition of materials and suppliers, and a declaration of conformity certifying that levels are below the regulated thresholds for each use category.
What penalties does PFAS non-compliance entail?
Mandatory product withdrawal from the market, administrative fines according to each Member State's legislation, civil liability for health damages resulting from exposure, and prohibition of commercialization until conformity is demonstrated. Penalties are aggravated for products intended for children.
Are there viable alternatives to PFAS?
Yes, fluorine-free alternative coatings exist for waterproof textiles, ceramic and natural materials for non-stick cookware, and PFAS-free formulations for food packaging. The transition requires technical validation of equivalent performance and cost-benefit analysis.
How does AI help with PFAS Regulation compliance?
AI systems cross-reference supplier chemical composition databases with regulated thresholds by product category, identify non-compliance risks before manufacturing, and generate structured, auditable conformity documentation for each production batch.
Ensure PFAS 2019/1137 compliance for your products
Our specialists analyze the chemical composition of your materials, compare results against regulated thresholds, and generate a complete conformity declaration. Get guaranteed certification with auditable documentation.
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