This step by the commission was prompted by the announcement in 2016 that Germany was intending to regulate printed food contact materials at the federal level.
The commission envisages that its traditional regulatory approach, as applied in the Plastics Implementing Measure Regulation 10/2011, will be problematic for printed food contact materials, due to the volume of new substances to be risk assessed and the length of time this currently takes.
It has released a discussion document dated 5 May 2017, which proposes an entirely different regulatory model. This would rely on designated bodies — commercial laboratories or consultancies accredited by member states of the EU.
The designated bodies would be independent from food contact material business operators. They would undertake certification work to ensure compliance at each stage of the manufacturing process for printed articles like packaging. As laid down the duties of designated bodies would be quite extensive, though most are not added requirements to the existing obligations in the supply chain. Among the activities would be:
- Migration testing
- Identification of migrating substances
- Toxicology tests and interpretation of results
- Evaluation of applicable rules
- Decisions on safety
The scheme foresees legislation containing the main obligations. These might cover more than procedures and functioning of the new system. Risk assessment, rules based on the mode of contact, and hazard and exposure rules could be placed in the basic regulations.
“The rule base will clearly be a key document in this approach.” explains to Dr Irvine. “It will for example, determine how to risk assess substances and in which cases it may be possible to use the Threshold of Toxicological Concern concept and exposure estimates using the Toxtree and FACET tools and the n in which cases experimental toxicology needs to be commissioned. Without use of these tools, the timeline for implementation of this approach will be held up by the need for large volumes of toxicological testing, so this document will be critical to the success of this approach”.
Right to overrule
Under a designated bodies approach, it is understood that member states have the right to overrule a certificate granted by a designated body.
“The right of member states to challenge the assessments of designated bodies could prove to be a complicating factor,” suggests Dr Irvine. “How this plays out will depend on whether the member states are confined to challenging decisions because they haven’t been carried out according to the ‘Rule base’, or whether they may challenge on other grounds. In the latter case, it could quickly emerge that different member states take differing views on the same assessment depending on the degree of caution in their outlook. Some sort of resolution mechanism would be required in these cases to ensure that all EU member states agree on the safety of individual materials and that products can be freely transported across borders.”
A balanced approach
The designated body procedures would try to achieve a balanced approach. This is partially because the capacity for the European Food Safety Authority (EFSA) to evaluate substances is limited. European Commission outlines new approach for printed materials
“There are certainly both benefits and disadvantages to passing responsibility back to the producers of materials through the designated bodies” explains Dr Irvine. “In principle, this will free up EFSA to deal only with higher exposure and higher risk substances, but it does rely on industry playing its part and this will certainly have cost implications.”
Speaking on the ease of getting agreement on this as a legal approach, Dr Irvine explains: ‘It is certainly not yet a done deal that the new approach will become adopted as there are very many stakeholders who would need to agree to the approach, not least the member states, the European Parliament and the European Commission lawyers. Whilst these bodies all agree that something needs to be done, history has taught us that the path to agreement on new legislation can be tortuous and involve many compromises.
Looking to the future, Dr Irvine also adds “If this approach, or something close to it, is adopted for inks and seen to be successful, it could clearly form the basis for future rules on coatings and adhesives, both of which face some of the same challenges as inks.”
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