EU Food Contact Plastics Regulation (EU) No 10/2011: Strict Purity Standards and Usage Limits for Carbon Black
ENFORCEMENT TIMELINE
In force since May 1, 2011 (progressively amended since then, including by Regulation (EU) 2023/1442)
Overview
The EU Food Contact Plastics Regulation (Commission Regulation (EU) No 10/2011) sets out a positive list of chemical substances permitted in plastic materials and articles intended to come into contact with food within the EU, along with migration limits and purity requirements for certain additives. Carbon black (FCM Substance No. 411) — widely used as a colorant and as a conductive or reinforcing filler in packaging, cookware, and resin components of food-processing lines — is subject to particularly strict specification requirements set out in Annex I.
Under the Regulation, carbon black may be used up to a maximum of 2.5% by weight in plastics only if it meets purity specifications including a primary particle size of 10–300 nm, toluene-extractable matter of no more than 0.1%, benzo[a]pyrene (BaP) content of no more than 0.25 mg/kg, and total polycyclic aromatic hydrocarbon (PAH) content of no more than 5 mg/kg. Furthermore, based on the latest European Food Safety Authority (EFSA) assessments — including those reflected in the amending Regulation (EU) 2023/1442, published in July 2023 — the evaluation criteria for nanoparticle forms and carcinogenic aromatic impurities continue to be strengthened, making rigorous analysis and maintenance of compliance documentation essential across the supply chain for food packaging materials and manufacturing equipment components.
Enforcement Timeline
January 14, 2011: The Food Contact Plastics Regulation (EU) No 10/2011 is adopted (entering into force on May 1 of the same year).
August 2016: Regulation (EU) 2016/1416 revises specific migration limits (SMLs) from plastic materials and impurity testing methods.
September 2020: Regulation (EU) 2020/1245 enters into force (strengthening heavy-metal migration limits and adding migration assessment requirements for reusable products).
July 11, 2023: Amending Regulation (EU) 2023/1442 enters into force (revising permitted requirements for specific chemical substances and tightening evaluation criteria for nanomaterials and impurities).
Business Impact
Food packaging manufacturers, container colorant and masterbatch producers, and manufacturers of resin components for food-processing equipment must demonstrate — through certificates of analysis (CoA) issued by raw material suppliers or third-party analytical data — that the carbon black they use meets the trace-impurity purity requirements for PAHs and BaP set out in Annex I of Regulation (EU) No 10/2011.
Companies must also confirm compliance with the Overall Migration Limit (10 mg/dm²) for the finished plastic article and the Specific Migration Limit (SML) for trace organic impurities derived from carbon black, and establish a system for preparing and retaining Declarations of Compliance (DoC) for presentation to customers and authorities.