Could our product contain a banned persistent pollutant?

Regulation (EU) 2019/1021 implements the international rules on persistent organic pollutants in EU law. Its core is short: the manufacturing, placing on the market and use of substances listed in Annex I, whether on their own, in mixtures or in articles, is prohibited, and the substances in Annex II are restricted, both subject to Article 4 (Article 3(1) and (2)). The Regulation takes its definitions of article, substance, mixture and placing on the market from REACH (Article 2).^[1][2]

The exemptions are narrow. Article 3 does not apply to a substance used for laboratory-scale research or as a reference standard, or to a substance present as an unintentional trace contaminant, as specified in the relevant entries of Annex I or II (Article 4(1)). An unintentional trace contaminant is a level incidentally present in a minimal amount, below which the substance cannot be meaningfully used (Article 2(12)). The tolerated levels are therefore set per substance in the annex, not in the articles of the Regulation.^[1]

The entries carry concrete numbers. The PFOA entry tolerates PFOA or its salts up to 0.025 mg/kg in substances, mixtures or articles, and any individual PFOA-related compound or combination of them up to 1 mg/kg (points 1 and 2). The PFHxS entry sets 0.025 mg/kg for PFHxS or its salts and 1 mg/kg for the sum of PFHxS-related compounds (points 1 and 2). The entries on tetra-, penta-, hexa-, hepta- and decaBDE set a sum of 10 mg/kg in mixtures or articles other than food contact materials, allow electrical and electronic equipment within the scope of the RoHS Directive by derogation, and set higher, falling values for articles made of recovered material and for toys and childcare products made of it. SCCPs are allowed in articles below 0.15 % by weight. Some entries tighten on fixed dates, such as UV-328 (100 mg/kg from 4 August 2025, 10 mg/kg from 4 August 2027, 1 mg/kg from 4 August 2029) and Dechlorane Plus (1 000 mg/kg until 15 April 2028, then 1 mg/kg). Several entries also allow named uses until set dates, for example in aircraft or vehicle parts.^[1]

The list moves. The Commission adopts delegated acts to amend Annexes I, II and III, with a separate act for each substance (Article 15(1)). For a substance added after 15 July 2019, articles produced before or on the date the Regulation becomes applicable to it get a six-month period, and articles already in use on that date remain allowed (Article 4(2)). Member States set the penalties (Article 14). A compliance file for POPs is therefore a dated record: which entries, which limits, which supplier statements and which tests.^[1]

The limits do not replace the general safety duties. For everyday consumer articles without a product-specific harmonisation act, the POPs limits apply alongside the General Product Safety Regulation, Regulation (EU) 2023/988, so manufacturers and importers follow both: the limits, and the GPSR's risk analysis, technical documentation, identification and address duties (Articles 9 and 11).^[3]