Regulation (EU) 2022/1616 requires, that the recycling process used to manufacture the food contact plastic must have a valid application for an EFSA (European Food Safety Authority) opinion or already have an EFSA opinion covering its intended food use.

EFSA guidance document

For the details, EFSA prepared a guidance document in 2008, which specifies the administrative and technical data that applicants should submit in a dossier for the safety assessment of a plastic recycling process (EFSA Journal (2008) 717, 1-12). The dossier shall be composed of three sections: a summary document, an administrative part to identify the legal entities and the business involved and a technical dossier. Here the application should be described clearly, with a description of the type of plastic and, in general terms, of the main key steps of the process, especially those contributing to removal of potential contaminants. Moreover, information on the intended use of the recycled plastic such as percentage in the final article, single-use or repeated-use applications, food types and contact conditions should also be provided.

Afterwards, the EFSA will, where appropriate, issue opinions, recommendations, specifications or restrictions on the input, on the recycling process or on the use of the recycled plastic. It should be noted that these guidelines do not cover environmental aspects such as persistence in the environment, ecological impact of food contact materials constituents and their fate after the food contact material has been submitted to waste disposal treatment.

EFSA scientific opinion on mechanical recycled PET

One of the first available EFSA publications regarding recycled plastics is the “Scientific Opinion on the criteria to be used for safety evaluation of a mechanical recycling process to produce recycled PET intended to be used for manufacture of materials and articles in contact with food” from July 2011. Most knowledge on recycling exists for PET as it is by far the worldwide most frequently recycled polymer for food contact uses. Furthermore, it is characterized by a limited range of additives used and a low diffusion of potential migrants in the polymer matrix. The risks associated to the use of recycled plastic materials in contact with food arise from the possible migration into the packaged food of contaminants present in the recycled plastics. In the case of recycled PET, the following contaminants are amongst others considered by EFSA:

• Contaminants from possible misuse: PET containers used for food may be misused by consumers after food consumption to store chemicals
• Chemicals from non-food consumer products: PET containers can be used in contact with non-food products (cosmetics, personal hygiene products, household cleaner) and sorb nonfood substances
• Chemicals used in the recycling process: Chemicals such as detergents and alkali used for the washing represent another possible source of contamination
• Degradation products of the plastic: During the various steps of the recycling process, e.g. high temperature treatments, the polymeric chain may break down to smaller molecules and any additives or sorbed compounds may react and be converted into new compounds

The “Challenge Test”

Taking into account the above mentioned potential sources of contamination of the input, it has to be demonstrated, that the process is able to reduce contamination to levels not posing a risk to human health for the intended use of the final product. This is generally achieved by a so-called “Challenge Test”¹. For this purpose, plastic is highly contaminated with model chemicals as surrogate contaminants. The choice of these substances should cover the physico-chemical characteristics and properties of potential contaminants. A possible mixture could be: Toluene / Chlorobenzene / Phenyl cyclohexene / Benzophenone / Methyl stearate. This mixture of surrogates cover not only a wide spectrum of volatility and polarity properties but also the full range of migration-relevant molecular weights. The contaminated plastic is then introduced into the recycling process and the residual concentration of the surrogate contaminants is determined after the process, hence yielding the decontamination/cleaning efficiency of the recycling process. As a conclusion, the EFSA Panel considered appropriate that the proportion of PET from non-food consumer applications should be no more than 5% in the input to be recycled.

EFSA opinion on mechanical recycled polyolefines

To date around 160 scientific opinions or safety assessments resp. have been published by the EFSA and most of them (> 140) are related to PET processes. More difficult is the situation in regard to the mechanical recycling process of polyolefins for the subsequent use as FCM. Due to the higher migrant affinity of PP or especially PE, caused by the lower polarity, the process must be seen more critically.

Therefore, until now only 6 scientific opinions dealing with the use of recycled polyolefines are published by EFSA with the conclusion, that the requested recycling processes are of no safety concern for PP and/or HDPE crates or trays intended to be used in contact with whole fruits and vegetables at room temperature or below. In one case the panel noted the limited decontamination efficiency under the condition of the challenge test and concluded, that the process for the manufacture of recycled HDPE bottles for milk and fruit juices does not meet the selected safety criteria. In another case EFSA concluded that the applicant has not demonstrated that the recycling process is able to reduce the contamination of the PE or PP recyclate (from offcuts and scrap) to a concentration that does not pose a risk to human health.

^{1 _{Surrogates in a challenge test: R. Franz, F. Bayer, F. Welle: Guidance and Criteria for Safe Recycling of Post Consumer Polyethylene Terephthalate (PET) into New Food Packaging Applications; EU-Project FAIR-CT98-4318 "Recyclability" February 2003}}