This article presents available documentation on the methodology for risk assessment. It was received via the FIP network from EFSA and from national bodies. It also reviews information from the industrial professional associations.
EFSA gives scientific opinions on the use of substances in materials that are regulated at EU level. Available guidance documents are:
Plastics: Guidance document on the submission of a dossier on a substance to be used in Food Contact Materials for evaluation by EFSA by the Panel on additives, flavourings, processing aids and materials in contact with food (AFC).
Active and intelligent substances: Guidelines on submission of a dossier for safety evaluation by the EFSA of active or intelligent substances present in active and intelligent materials and articles intended to come into contact with food.
EFSA also gives a scientific opinion on recycling processes that intend to give recycled plastic to be used in contact with food. Available documents are:
Guidelines on submission of a dossier for safety evaluation by the EFSA of a recycling process to produce recycled plastics intended to be used for the manufacture of materials and articles in contact with food – Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC).
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 the manufacture of materials and articles in contact with food.
EFSA has published several documents on risk assessment of chemicals. The list is included here.
Section III.A of “Overview of the risk assessment and of the national Regulations, as provided by the Member States” of the ESCO report (EFSA, 2012) has analysed the situation of the risk assessment in European countries. JRC desk research using two rounds of feedback from the Member States and NRLs, in addition to the information collected from the questionnaires of DG Health and Food Safety in 2012, was integrated. The summary is presented below including a summary of the information collected regarding “who does what” in the field of risk assessment in EU.
List of national bodies that perform the risk assessment:
|MS||Body||RA and references|
|CH||Independent division within the Federal Food Safety and Veterinary Office (FSVO)||– RA of FCM substances|
– Reference is EFSA for new substances; now only for printing inks (in close cooperation with BfR)
– Reference for P&B is CoE
|AT||Austrian Agency for Health and Food Safety (AGES)||– specific positive list of substances does not exist with exception of enamel which is covered by the Austrian ceramic legislation|
– RA of FCM-substances is focused on “contaminants” (e.g. Bisphenols, Phthalates and other plasticizers, elements) in food or food simulants within the official control of FCM.
– In special cases RA of FCM substances regarding the exposure and health effects to the population is carried out.
– RA is performed using the usual processes, e.g. laid down by EFSA (in addition e.g. TTC-Concept) or WHO.
|BE||Conseil Supérieur de la Santé:||– advice required by the ministry of public health; Sci-Com of Agence fédérale pour la sécurité de la chaîne alimentaire (AFSCA): advice required by AFSCA|
– RA details not available
– The assessments differ case by case depending on available data, on type of material. European standards are followed as much as possible.
|BG||Not available||– Details not available|
|CY||Risk Assessment Unit in the State General Laboratory||– dietary RA, not of FCM substances|
– RA for some specific cases
– For no specific SML , RA based on existing TWI, ADI, etc. + consumption data
Exposure/risk assessment is performed in the cases where there are no specific SML for some FCM either at National level (or other MS or at EU level). Risk assessment is based on the existing TWI, ADI, etc. and the consumption data.
|CZ||National Institute of Public Health (NIPH)||– RA of FCM substances|
– Reference is SCF-FCM, EFSA
– Some substances present on national positive lists for specific materials (particularly for paper and board) come from BfR recommendations.
National regulation Act No 258/2000 Coll on Public Health Protection, specific measure: DECREE No. 38 of the Ministry of Health of 19 February 2001 Coll., on hygiene requirements on products intended for contact with foodstuffs and foods
CZ Zakon 258-2000 introduces very generally the need for risk assessment, without any specific detail. (Hlava V, díl 1, oddíl 1, § 79). The risk assessment for substances in positive lists is performed by the national authority for risk assessment, the National Institute of Public Health (NIPH), based on the technical dossiers submitted by the petitioners according to national rules. Since 2004 the risk assessment is performed by the NIPH and is based on the dossiers submitted by the petitioners, according to the SCF-FCM guidelines and the Note for Guidance of EFSA for plastic FCM. Some substances present on national positive lists for specific materials (particularly for paper and board) come from BfR recommendations.
|DE||Bundesinstitut für Risikobewertung (BfR)||– RA of FCM substances (BfR Opinions)|
– Reference is EFSA for substances to be used in P&B: specific guidance for the determination of exposure assuming 100 g/m2 paper and 6 dm2 paper are in contact with 1 kg food
– RA for substances used in printing inks are prepared together with FSVO (CH).
– Exchange of information with RIVM (NL) on substances which are requested for addition to DE Recommendations and vice versa on petitions for the Warenwet (NL).
– Recently a closer cooperation with RIVM in the risk assessment of substances for FCM was discussed.
Risk assessments are published in form of ―Recommendations‖ on FCM (The BfR Recommendations), which are not legal norms.
They represent the current state of the scientific and technical knowledge for the conditions under which consumer goods made of high polymer substances meet the requirements of Article 3, paragraph 1 a of the Regulation (EC) No 1935/2004 in respect to their health safety. The Recommendations mainly consist of substance lists; general requirements are also included. Each recommendation focuses on a specific kind of food contact material (e.g. silicones). Restrictions are normally formulated as maximum content in the material. For the inclusion of a substance in the list, a petition has to be filed which has to follow the Note for Guidance of EFSA for plastic FCM. Risk assessment is done by the Federal Institute for Risk Assessment (BfR) which is supported by the respective Subcommittees of the BfR Committee for Consumer Products. If all requirements are met the respective substance is included in the Recommendation.
•DE (EFSA Note for Guidance for Petitioners presenting an Application for the Safety Assessment of a Substance to be used in Food Contact Materials prior to its Authorisation) → used as basis for assessment of substances for which an application is submitted (e.g. for substances to be included in BfR-Recommendations)
•DE (EFSA Opinion on Exploring options for providing advice about possible human health risks based on the concept of Threshold of Toxicological Concern (TTC)) → taken into account in other cases than applications
•DE (EFSA Margin of Exposure approach) → taken into account in other cases than applications
NOTE: The BfR publishes “Recommendations” which are treated like recommendations for GMP and contain positive lists etc. Apart from this, the BfR also publishes “Opinions” which contain the results of risk assessment on current topics (e.g. ITX)
|DK||Danish Technological University (DTU) (framework contract)||– RA of FCM substances|
– Do not follow EFSA’s note for guidance of FCM substances
– Substances with TDI or exposure reference values (used also for substance of the same group): case by case – Where a margin of exposure reference value, BMDL10, is available, margin of exposure calculations have been used for evaluation of the potential health risks associated with a given migration/exposure. – Potential exposure of chemicals from FCM: most testing using food simulants (data converted into mg/kg food by using the appropriate surface-volume ratio or the factor 6 dm2/kg food). – Worst case scenario of food consumption to get an estimate of worst case exposure of a given substance is used. – Non evaluated substances: hazard identification by testing case by case and by using different tools (in-vitro test methods, read-across methods and animal testing). For endocrine disrupting substances, mixture effects are also under evaluation. – Potential risk associated with estimated exposure is evaluated if data on substance hazard is available.
|EE||No national body for RA.|
Estonian University of Life Sciences provides opinions /expertise – Cooperation with German Federal Institute for Risk Assessment
|– Setting up a system for RA of FCM substances|
– In preparation, but limited resources
|EL||Scientific Council of Food Control (ESET)||– No RA of FCM substances|
– Any available experimental data, and RA of other EU MSs
– No risk assessment of FCM chemicals due to the lack of governmental funding.
– P&B: limits are taken from CoE
|ES||Scientific Committee of the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN)||– RA of FCM substances|
– Reference for P&B: CoE
– So far, no toxicological evaluations of non-plastic FCM substances
(Resolución de 4 de noviembre de 1982 – B.O.E. 24.11.1982) for polymeric materials lists the substances to be used for the manufacture of macromolecular compounds; it includes under its scope silicones, rubbers, coatings, ion exchange resins and adhesives.
The risk Assessment is performed by the Spanish Food Safety and Nutrition Agency (AESAN) and petitioners can be official administrations, industry, consumers associations or the AESAN. So far, no toxicological evaluations have been performed of substances used in non-plastic FCM.”
|FI||Finnish Food Safety Authority (Evira)||– No RA of FCM substances; CM business operators manufacturing, converting or importing plastic materials and articles, are prioritized for controlling since that is covered by legislation and guidance.|
– Reference is EFSA
– Use of internationally accepted RA principles. Recommendation to operators to use FACET. FI focusses their resources on enforcement activities.
|FR||Agency for Food, Environment and Occupational Health and Safety (ANSES)||– RA of FCM substances|
– Reference is SCF-FCM, EFSA
– A RA for substances with a molecular mass of <1000 Dalton in printing inks has to be performed.
The risk assessment is performed by French Agency for Food, Environment and Occupational Health and Safety (ANSES)
It is based on the dossiers submitted by the petitioners, according to the SCF-FCM guidelines and Note for Guidance of EFSA for plastic FCM. Consequently, the evaluation is done according to the usual tiered approach, but in case of very low migration and in absence of genotoxicity structural alerts, a threshold of 0.5μg/kg food is applied. The advices and scientific opinions are usually endorsed into laws, or considered as major recommendations. A compendium of these regulatory decisions is edited by the Journal Officiel de la République Française (JORF) and is known as Brochure 1227 JORF 1994. Matériaux au contact des denrées alimentaires, produits de nettoyage de ces matériaux. Brochure 1227. 5Paris : Journal Officiel de la République Française (éditeur), collection Brochure 1227, 1994/01, 260 p., tabl., ISBN 2-11-073441-8, FRA). For printing inks: FR Avis DGCCRF du 10 juin 2010 specifies that for substances with molecular mass <1000 Dalton risk assessment has to be performed. (Chapter 3.2.1)
|HR||Croatian Food Agency||– RA for some specific cases|
– Reference is EFSA’s note for guidance for FCM substances
– Only 4 cases so far (2012-2014)
|HU||National Food Chain Safety Office (NFCSO) (CA)||– General RA procedure (dietary RA)|
– No experience on FCM RA. Use of EFSA opinions
|IE||Food Safety Authority of Ireland||– No systematic RA of non-harmonised FCMs|
– A RA assessment may be carried out on an ad-hoc basis (as part of an incident, rapid alert, etc.),
– Reference SCF/EFSA note for the guidance of FCM substances.
|IT||Istituto Superiore di Sanità (ISS)||– RA of FCM substances|
– Reference is SCF-FCM (now EFSA)
– Differences in migration testing for some materials (e.g. P&B: compositional requirements; stainless steel: pre-established limits for metals etc.).
– Only legislations from other EU MS that are notified to TRIS system are under mutual recognition.
– P&B: Specific provisions indicated for recycled fibres (admitted only in special cases).
Risk assessment is performed according to the SCF-FCM guidelines. To get the positive listing, a technical dossier submitted by the petitioners has to be evaluated by the Istituto Superiore di Sanità (ISS), the Technical/Scientific Body of the Ministry of Health, where the risk assessment is performed. The final decision on the positive listing is laid down by the Ministry for Health, the Management Body, after advice from the Consiglio Superiore di Sanità (Higher Health Council).
|LT||National Food and Veterinary Risk Assessment Institute (NFVRAI)||– RA of FCM substances in preparation|
– No risk assessment works on FCM yet
|LV||Institute of Food Safety, Animal Health, and Environment BIOR||– Reference is EFSA-FCM note for guidance for FCM substances|
– No RA has done yet for substances in non-harmonised materials
– Mutual recognition principle to the FCM is applied when LV gets RASFF notification from other MSs where there is national legislation according to material groups which do not fall under Article 5 of Regulation 1935/2004.
|LU||none||– Use of recommendations from DE, FR, BE or EFSA|
|MT||Not available||– Details not available|
|NL||Commission G4 (Ministry of Health, National Institute for Public Health and the Environment (RIVM), Inspectorate, and Industry)||– RA of FCM substances, RA for NIAS based on TTC in development|
– Reference is EFSA (with sometimes adjustments on exposure scenarios)
– Most substances on the list from decades ago on basis of only limited information
New substances are evaluated by Commission G4, in which the Ministry of Health, the National Institute for Public Health and the Environment (RIVM), the Inspectorate, and the Industry are represented. NL Commodities Act (Packagings and Consumer Articles) has a chapter on risk assessment of non-intentionally added substances (NIAS) based on the TTC principle. (Hoofdstuk III). Risk assessments (Summary Data Sheets) are made according to the same method used by EFSA for plastics, with sometimes some adjustments on the exposure scenarios, e.g. for some special products, the lower surface to content ratio‘s (than the 6 dm2 per kg food as used for plastics) are used. Most substances, however, have been put on the list decades ago on basis of only limited information.
|NO||Norwegian Scientific Committee for Food Safety (VKM) on requests from the Norwegian Food Safety Authority||– RA of FCM substances|
– Reference not available
– Very few RA performed (last in 2008 for printing inks substance)
Risk assessments of non-plastic FCM are conducted by the Norwegian Scientific Committee for Food Safety (VKM) on requests from the Norwegian Food Safety Authority. It is done in the form of summary data sheets
|PL||National Institute of Public Health – National Institute of Hygiene||– RA of FCM substances|
– Reference is EFSA, BfR, CoE or industry recommendations
BfR, CoE or industry recommendations are used as guidance values for risk assessment related to all materials for which no specific Polish measures exist (namely adhesives, cork, ion-exchange resins, metals and alloys, printing inks, rubbers, silicones, varnishes & coatings, waxes, wood, and multi-materials).
|PT||Not available||– Details not available|
– P&B: CoE is used as guidance for RA
|RO||Not available||– Details not available|
|SE||Swedish National Food Agency||– RA of FCM substances|
– Details not available
SE: Risk assessment provisions: Report on risk profile for food contact materials – Environmental and Food Agency of Iceland (2011); Guidance Guide on food packaging safety (January 2012)
|SI||National Laboratory of Health, Environment, and Food||– RA of FCM substances; do not use EFSA’s note for guidance for substances in non-harmonised materials|
– Applicable RA guidelines; exposure scenario’s: CoE, BfR (case-by-case)
– Risk characterization: health-based values set by one of the competent organizations /committees (EFSA, SCF, SCHER, WHO, US-EPA, ATSDR,…)
When Slovenian authorities perform official control and risk assessment of the specific sample of FCM, they use and refer to Resolutions from the Council of Europe or guidance documents from other countries (e.g. the German BfR recommendations).
|SK||none (part of NRL work)||– No RA performed for substances for non-harmonised materials|
– Reference is EFSA-FCM note for guidance for FCM substances
– The necessity of RA of FCM substances is not fixed by law
– P&B: list consists of substances which were evaluated by other MSs
Decree of Ministry of Agriculture of the Slovak Republic and Ministry of Health of Slovak Republic of 9 June 2003. The risk assessment is not part of this decree.
|UK||Food Standards Agency (FSA)||– FSA supported by the Committee on Toxicity, (independent Scientific Committee on advice to FSA).|
– General RA procedure
– No national legislation on FCM – comply with Article 3 of EC 1935/2004
|Nordic countries||Norden||Document: Norden (“Food contact materials – in-house documentation and traceability, Nordic checklists to industry and trade “, TemaNord 2008:517, Copenhagen, Nordic Council of Ministers|
Provides guidance on control, traceability and declaration of compliance for FCM operators in general, including all the actors of the supply chain. It is based on EU requirements and proposes lists of information to be retrieved by suppliers to prepare an appropriate in-house supporting documentation. It states that “specific evaluation and risk assessment would have to be conducted on specific materials and articles, and the specific foods in contact and the processing conditions for the uses.”). Another Norden guidance specific to Paper and Board Food Contact Materials reports the need to perform risk assessment on NIAS. (Chapter 6.6, Annex 4)
|Industry||Plastics Europe||Document: “Risk Assessment of non-listed substances (NLS) and non-intentionally added substances (NIAS) under Article 19 of Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food”.|
The document considers exposure and toxicological assessment of a substance and its risk characterization. With this guidance document, PlasticsEurope intends to explain how the plastics (plastic intermediate material) producers interpret and respond to their risk assessment obligations for non-listed and non-intentionally added substances under the article 3 of the Framework Regulation (Regulation (EC) No 1935/2004) and article 19 of the Regulation on plastic materials and articles intended to come into contact with food (Regulation (EU) No 10/2011), based on internationally recognized tools and scientific knowledge available to them at the time of writing. This is a living document which will be updated when and if needed.
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