欧洲食品安全局对公众科学观点报告草案，食品接触材料中使用的物质的安全评价，及对食品化学物质风险评估的最新进展及其潜在影响。
The European Food Safety Authority (EFSA) carried out a public consultation in order to receive comments from the scientific community and stakeholders on the draft opinion on “Recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials” which was endorsed by the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) on 5-7 May 2015.
The public consultation was open from 7 July to 7 October 2015. EFSA received 205 comments and 4 data sets from 21 interested parties, including governmental and non-governmental organisations, industry organisations and consultants. EFSA wishes to thank all parties for their valuable contributions.
EFSA committed to publish a technical report on the outcome of this consultation on the draft opinion. The current report compiles all comments received during the public consultation, and outlines how the comments were considered for the finalisation of the Scientific Opinion. The revised version of the draft opinion was discussed and adopted by the CEF Panel on 2nd December 2015 during its 59th plenary meeting. This report on the outcome of the consultation on the draft opinion was endorsed by the Head of the EFSA Department of Regulated Products prior to its publication.
Following the suggestions received the introduction of the Opinion has been substantially modified, also stating clearly that the scientific opinion applies to substances in plastics that are regulated and evaluated by EFSA, but it also reports the view of the CEF Panel about the safety assessment of any substances that migrate from any food contact material (FCM). A more explicit description of the current regulations is provided as background information and certain rules used in reporting and interpreting migration test results are described in the section on exposure.
In line with the advice received, a clearer differentiation has been made in the opinion between migration (concentration) data based on modelling, simulation or measurements in foodstuffs. The CEF Panel (re)emphasised that simulation must be conservative against migration into foods and that different migration models or modelling parameters can be used if they are validated.
The CEF Panel’s proposal to refine the calculations of exposure in comparison with the current approach was generally welcomed by respondents. Depending on the party involved, the newly proposed approach was either considered as not sufficiently conservative or too conservative. The proposed strategy for estimating exposure is based on a tiered approach for specific population (age) groups (especially infants and toddlers) and specific FCM usage patterns. Whilst these levels of exposure do not hold for the whole life and are much higher than those observed in adults, the impact of exposure in early-life stages is increasingly considered relevant. Therefore, an alternative approach based on time-weighted food consumption is not considered to be suitable.
Considering the wide intended uses often requested in the applications submitted, the CEF Panel supports the estimation of likely migration using worst-case parameters (as regards time and temperature conditions of contact, polymer diffusivity, maximum intended use level, etc.). It should be noted that several parameters used in the calculation of the exposure are not conservative (e.g. S/V, not summing up the exposure calculated for different food types), this preventing the exposure estimate from being overly-conservative. A new section on calculating exposure has been added to the opinion. This provides information on how to combine the food consumption scenarios with migration and on the possible grounds for deviating from the standard approach. The use of an approach based on packaging use factors is mentioned in this section.
As a direct result of comments received along with data, a new category of food consumption for “solid foods specifically intended for infant and toddlers” was included in the tiered approach with the introduction of a new corresponding section to present the background for the consumption figures proposed.
Concerning substances in nano-form (nanomaterials, NMs) the release mechanisms from plastics into food (diffusion, swelling, abrasion etc.) are now better elaborated in line with comments made on this aspect. Several respondents asked if a threshold of migration or exposure to nanomaterials could be set, to trigger or obviate toxicity data requirements. The scientific understanding does not yet exist to set such a threshold level and NMs have to be evaluated case-by-case as the science develops. Some new text has been added in the section on toxicological assessment of nanomaterials to explain this point.
Considering the appropriateness of data needs from toxicity testing, specifically the use of experimental animals, the principles of consumer safety and animal welfare have to be respected and many comments were linked to this ‘balance’. Full utilisation of existing data/information on the toxicity of an applied substance and/or using methods that are alternatives to animal testing has been emphasised in the tiered approach (based on exposure) taken for toxicity testing. The text in the opinion has been modify to enhance clarity, in relation to the proposed tiered-approach which applies to all migrating substances while further considerations apply to NIAS for genotoxicity and toxicity testing. Along with non-animal testing methods, in vitro-tests may help to meet the EC requirement for a reduction, refinement and replacement (3Rs) of animal tests.
The text and the table on the tiered approach were updated to take into account further considerations on substances with potential endocrine activity and/or with potential effects from prenatal exposure. Several respondents highlighted these aspects. A new level of 30 µg/kg b.w. per day has been introduced into the tiered approach as the threshold for the investigation of repeated dose toxicity of Cramer Class I substances. If a substance is classified in Cramer Class I, then it has by definition a simple chemical structure and can be expected to be efficiently metabolised, suggesting low oral toxicity.
