Q. With three changes to the legislation already in 2018, this seems to be a step change in the pace of EU regulation in food contact materials. What do you think is behind this?
There is no doubt that the European Commission have come under increasing pressure to make progress with the regulation of food contact materials; in October 2016 the European Parliament adopted a Resolution on the Implementation of the Food Contact Materials Regulation 1935/2004, and this put more pressure on the European Commission to make regulatory progress. This was further backed up in January 2017 when the Joint Research Centre (JRC) of the European Commission (EC) has published its baseline study suggesting more progress was required to integrate food contact regulations. These have certainly put some pressure on the EC to deliver progress. Also, I think it is fair to say that industry have been keen to see shorter delays between new substances being approved by European Food Safety Authority (EFSA) and then appearing in the positive lists of the regulations.
Q. What effect do these regulations have?
In the cases of EU Regulations 79/2018 and 831/2018, the effects are relatively minor. These are what I would call housekeeping amendments in which the EC have aligned the positive list in Regulation 10/2011 to bring it into line with the most recent risk assessments from EFSA. In total, these amendments have added 6 substances to the positive lists of substances approved for use in food contact plastics and changed use restrictions on 4 substances. Previously, the EC would have saved these up and published a single amendment roughly once per year. Given that there are circa 1050 substances on the positive lists, it is clear that most users and producers of food contact materials probably won’t be significantly impacted by the changes on these few substances. But there will be a small percentage who are affected.
Q. So what should producers and users of food contact materials do to respond to these changes?
The first and most obvious action would be to check through the list of substances in your food contact materials to ensure that these have not been impacted by the recent changes. If you don’t have access to the full list of substances in the plastics, you may need to ask your suppliers for an up-to-date Declaration of Compliance which covers these amendments.
Q. If the Regulation is now to be amended with this level of increased frequency, will this pose difficulties for the supply chain?
There is no doubt that frequent changes to the regulations will mean that the shelf-life of food contact Declarations of Compliance will be shorter and they will need to be reviewed more often – possibly several times a year and this means that communication in the supply chain becomes even more important. If change with this frequency becomes the norm, it is even possible that industry who certainly gain from the shorter time line in new approvals may come to view the old pattern of annual amendments as more desirable.
Q. I believe that EU Regulation 213/2018 is a little different. Can you tell us a more about that?
Yes, EU Regulation 213/2018 is a different type of regulation and focuses on the long-running issue of Bisphenol-A (BPA). The regulation has three key measures;
- Firstly, it reduces the specific migration limit (SML) for BPA down to 0.05 mg/kg (i.e 50 ppb) from its previous value of 0.24 mg/kg. This is obviously a significant tightening of the limit for the migration of BPA and comes in response to the EFSA review on BPA published in 2015.
- In the case of packaging for infant foods, the SML is set at Non-detectable (ND < 0.01 mg/kg), so this an additional degree of caution which has been applied to packs for these applications.
- Lastly, we should mention that this limit applies to BPA regardless of whether it migrates from plastics or coatings.
Q. That sounds like a step change in the regulatory position of BPA in food contact. Do you think this is the end of the story?
In the case of BPA, it would be rash to say we have ever reached the end of the story. There is ongoing work being carried out by EFSA to continue reviewing new toxicological information on BPA and I wouldn’t be surprised if this led to further legislative changes.
For advice on how this new regulation might impact your food contact materials, please contact our expert team to see how we can support your regulatory submissions.
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