EU Commission’s DG SANTE publishes Inception Impact Assessment as roadmap for revision of EU regulations on food contact materials; outlines eight main “issues” identified during ongoing evaluation, possible policy options to be considered by planned Impact Assessment; commenting period open until January 29, 2021
On December 18, 2020, the European Commission’s (EC) Directorate General for Health and Food Safety (DG SANTE) opened a consultation on its inception impact assessment (IIA, which is essentially an extended roadmap) for the ongoing evaluation and revision of EU legislation on food contact materials (FCMs). The consultation is open until January 29, 2021. DG SANTE is set to host a webinar to present the roadmap on January 20, 2021.
In the published IIA document, which can be downloaded from the consultation’s webpage, DG SANTE summarizes that “the basic provisions of the present EU [FCM] legislation were introduced in 1976 but until recently had never been evaluated.” Therefore, in 2018 the ongoing Evaluation of FCM policy legislation was initiated, starting with a first stakeholder workshop (FPF reported), which was followed by a public consultation (FPF reported) and a second stakeholder workshop (FPF reported). This still-ongoing evaluation covers both the general FCM framework Regulation (EC) No 1935/2004 as well as several more specific FCM-relevant legislation pieces, such as Regulation (EC) No 10/2011 on plastic FCMs. The evidence and feedback collected by the EC so far have confirmed the existence of “problems that are linked to the absence of specific EU rules, which leads to uncertainty about safety of some FCMs and internal market problems.” Broad support for the need to introduce “further specific EU legislation” was expressed “by all stakeholders including EU Member States, the European Parliament, industry, and non-governmental organizations.” In addition, “several [other] fundamental issues present in the existing approach” were revealed.
Problems intended to be tackled through revising the EU’s FCM legislation
The IIA outlines the following 8 “fundamental issues,” which “relate both to the absence of EU specific measures (1) as well as various aspects of the current EU rules (2-8) as follows”:
1. “Lack of functioning of the internal market and possible safety issues for non-plastics FCMs.” The absence of harmonized EU rules for most FCM types results in “a lack of a defined level of safety and consequently no appropriate legal basis for industry to carry out compliance work.” In addition, difficulties with enforcement and control of imports are highlighted as accompanying challenges.
2. “The positive authorized list approach and lack of focus on the final article.” While some stakeholders view positive authorized lists as “advantageous,” it is also recognized that the use of positive lists can “bring practical problems and limitations” and result in “excessive burdens for public authorities and industry alike.” For example, “the creation of lists causes a significant obstacle to harmonization of rules for other materials such as inks, rubbers and adhesives.” An additional burden comes from the need to “re-evaluate certain substances when new scientific information becomes available.” Furthermore, current FCM assessments which are focused on the starting substances “do not sufficiently address the safety of the final product” and also do not consider “the actual potential use and lifespan of the final article and consequences of the aging of the material.” This approach “puts a disproportionate emphasis on starting substances, leaving the safety of the final material for the supply chain to resolve without clear rules,” DG SANTE concludes.
Food Packaging Forum, 18 December 2020