Short notice on the 18th amendment to Plastic regulation EU 10/2011

Short notice on the 18th amendment to Plastic regulation EU 10/2011

In March 2024 the EC published its draft 18^th amendment to the plastic regulation EU No 10/2011 on plastic materials and articles intended to come into contact with food and amending Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food. It concerns recycled plastic and other matters related to quality control and manufacturing of plastic materials and articles intended to come into contact with food.

It involves among others

1. new labeling requirements (the maximum lifespan for repeated use articles),
2. adjusting requirements for migration testing (use the actual surface to volume ratio for small articles < 500 mL, specific performance criteria for analytical methods used during compliance testing),
3. new requirements concerning the “high degree of purity” for the substances that are used for the manufacturing of plastic material and articles and,
4. adjusting the rules for re-processed plastics.

One concern is adjustments that involve the high degree of purity requirements that will be added to new article 3a and to article 8 related to starting substances and intermediates and includes substances of natural origin or from waste material.

High degree of purity: A substance used in the manufacture of plastic materials and articles shall be considered as having a high degree of purity where all of its constituents form part of its identity, and it otherwise contains only a minor amount of contaminants and non-intentionally added substances that fulfil one of the following conditions;

1. comply with the relevant regulations,
2. considered compliant after risk assessment,
3. genotoxicity is ruled out after individual tox assessment and present at residual levels below 0.05 mg/kg food or
4. if genotoxicity cannot be ruled out based on ii) or iii) and assuming their full migration from the final article into food is below 0.00015 mg/kg food.

These adjustments on the regulation will have a significant impact on the whole supply chain, and this was underlined by that no less than 124 parties have submitted their comments and concerns on this draft version.

Our experts can be of assistance with implementing this new amendment for your products once into force. Triskelion dedicated services includes the investigation for the high degree purity of your substance or intermediate. This includes chemical analysis of your substance for impurity profiling via screening techniques using sophisticated equipment and the corresponding risk assessment, all performed by our highly skilled professionals.

Please reach out to Steven Verheul if you want the be kept updated on the finalization of this regulation or want be proactive and discuss the needed actions already now!