20 Aug 2019
Food Contact Materials Law Amends Position on Use of a Substance in Plastic Packaging
The Official Journal of the European Union has published new Commission Regulation 2019/1338 which amends Regulation 10/2011 on plastic materials and articles intended to come into contact with food. Hong Kong’s food suppliers and suppliers of food packaging (e.g., food containers) to the EU market will likely know that this latter-mentioned law has established a Union list of authorised substances. Such substances may be used in the manufacture of plastic materials and articles intended to come into contact with food throughout the EU. In order to ensure that Regulation 10/2011 reflects the most recent findings of the European Food Safety Authority, that Regulation has had to be amended. Although Commission Regulation 2019/1338 will enter into force on 29 August 2019, manufacturers and suppliers are given a grace period of one year before they need to comply with its requirements.
The new Regulation concerns the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (FCM substance No 1059). This substance has already been authorised by Commission Regulation 2019/37 to be used either alone or blended with other polymers in contact with dry or solid foods under certain conditions.
The European Food Safety Authority has adopted a new favourable scientific opinion extending the use of this substance alone or blended with other polymers in the manufacture of plastics intended to come into contact with all foods. In the later opinion, the food authority concluded that this substance is not of a safety concern for the consumer, if:
- it is used either alone or blended with other polymers in contact with all foods,
- under contact conditions of 6 months or more at room temperature or below, including hot fill or short heating-up phases,
- provided that the migration of all oligomers with a molecular weight below 1 000 Da does not exceed 5.0 mg/kg food or food simulant.
The Authority's conclusion is based on the worst-case migration testing conditions for long term contact conditions (6 months or more) with food at room temperature or below. These worst-case migration testing conditions also address contact conditions of less than 6 months at room temperature or below. Therefore, the use of this substance alone or blended with other polymers in the manufacture of plastics intended to come into contact with all foods under contact conditions of less than 6 months at room temperature or below, including hot fill or short heating-up phases will also be of no safety concern. However, the migration of all oligomers with a molecular weight below 1 000 Da must not exceed 5.0 mg/kg food or food simulant.
In addition, the Authority also confirmed in its opinion that the specific migration limit of 0.05 mg/kg food set for the degradation product crotonic acid in the previous authorisation of the authorised substance should also apply under this extended use. The entry for this substance in the relevant table, namely, Table 1 of point 1 of Annex I to Regulation 10/2011, therefore now includes the uses of this substance with all foods and in all conditions, in column 10 of that Table.
Hong Kong sellers should make further note of an additional point concerning the provision on oligomers (see: the third bullet point above). The Regulation notes that, as analytical methods to determine the migration of these oligomers are complex, a description of those methods is not necessarily available to competent authorities in the EU. Without that description, it is not possible for the competent authority to verify that the migration of oligomers from the material or article complies with the migration limit for these oligomers.
In consequence, business operators placing on the market the final article or material containing that substance will have to include, in supporting documentation, a description of the method and a calibration sample if required by the method. As the framework law (Regulation 10/2011) requires “appropriate documentation to demonstrate that the materials and articles, products from intermediate stages of their manufacturing as well as the substances intended for the manufacturing of those materials and articles comply with the requirements of this Regulation” to be made available by the business operator to the national competent authorities, on request, it is necessary for the description of the method and a calibration sample if required by the method to be a part of this “appropriate documentation”.
New Commission Regulation 2019/1338 will enter into force on the twentieth day following that of its publication in the Official Journal. However, plastic materials and articles intended to come into contact with food complying with the framework law, Regulation 10/2011, as applicable before the entry into force of this new Regulation, may be placed on the market in the EU until 29 August 2020, and may remain on the market until exhaustion of stocks.