Entering business in any foreign country requires us to satisfy itself compliances and regulations. For FCM. Each country and area build itself regulations for protecting the right of humanity in their country. Let’s take a tour of those materials and methods of checking regards countries.
FCM – the general requirements
The starting point was DG Health and Food Safety’s 2011 list (check the DG Health and Food Safety document ‘INT/REF_LEG+Compend’(14/02/2011)) on national provisions. Searches were conducted of public websites (national authorities’ official websites, CoE, Norden, the Decernis Database (please note that searches were done by country, by materials) and by direct requests to the Members States’ competent authorities (DG Health and Food Safety — addresses of European and national authorities (updated where applicable).or via their NRLs. Documents were retrieved in English where possible and/or in the original languages. Input was also sought with several (three to four) rounds of direct queries or questionnaires sent to stakeholders, which aimed to ensure information on regulatory measures and supporting tools was complete, up-to-date and correct.
The content of the measures collected for non-harmonised materials covered under Regulation EC No 1935/2004 was examined under both a generic standpoint (general requirement common to all FCMs) and from a material-specific standpoint (legislation or national guidance for specific individual materials).
The general requirements examined included registration of food contact businesses, documentation of compliance (and supporting documents), details on GMP, risk assessment prior to authorisation, legal provisions providing for sanctions, actions and enforcement (i.e. details on how to undertake official controls such as sampling, responsible control authorities and their tasks, descriptions of test methods used, if applicable) and certification systems (i.e. authorisation of laboratories to perform compliance testing, details on requirements for compliance testing laboratories).
The existence of rules or implementation tools specific to individual materials was examined more specifically. This included lists of authorised substances for use in manufacturing processes and/or banned substances. It also considered supporting tools such as limits for specific migration or release specific migration limit (SML), the maximum the maximum amount of a component that may be allowed to migrate into the food, expressed in mg/6 dm² or mg/kg foodstuff, limits for overall migration (OML – Overall migration (OM): total amount that migrates from a packaging to a food simulant expressed in mg/6dm² or mg/kg), residual limits or limits on the amounts that can be added in material such as a quantity in material, i.e. limits for extractable/residual content; plus, residual content can be understanded as maximum permitted quantity of the substance in the finished material or article expressed as mg/kg of the finished article (QM) or per surface area QMA, QMA(T)) and compositional limits restricting the amount added to a material. It considered the nature of the substances regulated in different countries and restrictions imposed. It also included other documents such as recommendations, guidance, and scientific opinion provided by national bodies ranging from risk assessment to risk management.
FCM – measure and tools checking
An additional check was conducted to query whether the measures and tools collected were still in use and/or whether guidance from other countries or sources were applied in the absence of national measures or tools. Existing measures from non-EU countries were reviewed from peer-reviewed references or searches on the corresponding national websites (e.g. FDA, Japan, Mercosur and China). An overview of these can be found in the next article of National provisions in relevant non-EU countries.
Regarding GMP, the information was collected from earlier research conducted in 2012 by DG Health and Food Safety and updates from desk research from an exchange with stakeholders with a focus on GMP guidance documents from MSs and GMP guidance documents from professional associations. An exercise was also conducted with professional associations on the completeness and accuracy of GMP documents collected.
Regarding risk assessment, searches were conducted with a focus on EFSA, national risk assessment bodies and international organisations such as the Organisation for Economic Cooperation and Development (OECD), the European Chemicals Agency (ECHA) , Codex Alimentarius, scientific committees and consultancies. Particular attention was paid to the information already collected in the EFSA report of the ESCO Scientific Cooperation – the report of ESCO WG on non-plastic FCMs. Supporting publications 2012:139 [63 pp.], working group (therein EFSA ESCO report). An update on and confirmation of what schemes were applied to carry out risk assessments with respect to the statements reported in the EFSA ESCO report was done via queries to the national members of the Food Ingredient and Packaging (FIP) Network of EFSA.
For the industry sectors, the information was sought from the professional associations’ (listed on DG Health and Food Safety register of commission expert groups and other similar entities) websites and from previous information collected in 2012 by DG Health and Food Safety. Additional direct questionnaires and queries were sent to cover incomplete or missing parts. Documents were collected, where applicable, on industry guidance for business operators (including traceability, codes of practice, safety, hygiene, etc.), sector-specific GMP and industry or consultancy documents related to risk assessment.
The availability and content of the national measures were analysed in a first phase with the documents in their original language, since those were the only ones available. The first part of the work consisted in finding the relations between the different pieces of legislation. Preliminary approximate machine translations allowed identification and categorisation of the implementation tools provided for (or not) by national legislation and whether references in overarching national measures were actually implemented by specific measures, which was not always the case. The result of this work enabled the organisation of the content of the IT tool on dedicated templates and the development of its structure. It should be noted that the excerpts were kept in their original language as it was the only one with the true and accurate information.
In order to derive a more in-depth analysis, more reliable translations were sought. Requests were made in end 2014 to the Commission’s Directorate-General for Translation to have national measures translated into English from their respective national languages. As many texts exceeded 100 pages each, these translations could be of significant value not only for this baseline but also for future reference. However, the time to obtain these translations put a strain on the timeline of the final analysis.
The second phase of the work was dedicated to the analysis of content material by material and down to the level of the nature of substances regulated and their respective restriction levels in different MSs. Use was made of the EFSA ESCO report as a background work. The annexes to the ESCO report contained a list of substances for which a risk assessment evaluation had been made and was traceable to a MS and available. Lists were compiled by a group of experts for coatings, colorants, cork and wood, paper and board, printing inks, rubber and silicones. No common lists were compiled for adhesives, ceramics, glass, ion exchange resins, metals and alloys, multimaterials or wax. The presence of a substance included in the ESCO lists was based on the requirement of an evaluation prior to (list B) or after (list A) 1991 and based on the materials contributed by the experts. This was considered a valuable basis on which to review substances that are regulated by national measures (regardless of the availability and quality of a risk evaluation). A global update was undertaken in this study, which considers in a much larger sense the term ‘regulated’. The tasks included validating the data contained in the ESCO lists, systematically analysing every available national documents of either legal of softer nature (along with CoE policy statements and guides) and compiling the corresponding data.
With regard to GMP, the content of the information found in guidance documents (either national or industrially produced) were tabulated according to information on raw materials, quality assurance (QA), quality control (QC) and the nature and extent of certification systems.
With regard to risk assessment the information and usage of general nature provided by industry and by risk assessment bodies were compiled as in data in the next articles.