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Additional tools for exposure assessment

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Flavourings, Additives, FCMs Exposure Assessment Tool (FACET)

FACET is an exposure tool that was created as an EU-funded research project under the seventh research programme (KBBE-211686) and ran from 2008 to 2012. FACET was developed to estimate dietary exposure to flavouring, additive and FCM substances with the aim of significantly reducing the uncertainties in the level of dietary exposure for these classes of substances in the EU population. The project produced an exposure assessment tool consisting of databases containing information on the levels of food additives, flavourings and food packaging migrants and corresponding food consumption data.

For food packaging, data was collected on the chemical composition of food packaging materials, along with information on the extent and conditions of use. It included comprehensive data on substances in inks, adhesives, plastics, metal, paper and board (provided by the food packaging industry), and data on the construction of different packaging types (provided by the food packaging industry), and led to an inventory list of 6 475 substances that were either single substances or defined or non-defined mixtures of two or more substances. It linked to 15 dietary surveys from eight MSs (Ireland, France, Italy, Hungary, Poland, Portugal, Finland and the United Kingdom), harmonised into targeted coding systems aligned with those used by EFSA (EFSA’s food classification and description system (version 1)). These databases were linked to a migration model that can estimate the amount of a substance leaching from packaging into food, allowing exposure to the substance to be calculated for the food consumption data. The resulting FACET exposure tool is a downloadable software that can be used to estimate consumers’ exposure. This tool can, for example, be used to measure how different population groups (age, gender, people staying loyal to a given brand or changing products) are exposed to different types of packaging substances.

Flavourings, Additives, FCMs Exposure Assessment Tool (FACET)

In 2014-2015, FACET was tested and used within the EFSA exposure assessment of Bisphenol A (BPA) from light metal packaging (canned foods). The model gave similar results to the classical assessment obtained from deterministic data, showing the validity of FACET as a modeling tool in EU-wide assessment scenarios for FCMs. A novel module of FACET was sponsored by the FACET Industry Group (FIG, representing more than 10 FCM sectorial associations). Its functionality allows, in particular, the estimation of the exposure of NIASs migrating from a food packaging into a food.

Considering that the new proposed guidelines from EFSA (see section 3.4.1.) are bringing a stronger focus on exposure, FACET can present a uniqueness and added value not otherwise available for FCMs. However, it must also be noted that updates are fundamental to the future expansion and sustainability of FACET:

  • The food consumption data is becoming outdated. FACET will need to recode data and update to the new system of EFSA (Foodex2).
  • New surveys on food consumptions will need to be part of updates. This implies the need for a level of acceptance by EFSA of FACET, which can represent a valuable probabilistic tool in an area of gaps in the context of FCM exposure assessment.
  • A review and update of the Euromonitor data for FCMs will become indicated.

Matrix – Exposure Assessment Tool

Matrix is a web-based tool for risk assessments of NLSs and NIASs to be performed under Article 19 of Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. Under the provisions of the regulation, a number of substances present in food contact plastics are exempted, according to Article 6, from the requirement to be included in the Union positive list (Union list). The substances exempted from positive listing include solvents, colourants, polymer production aids (PPAs), aids to polymerisation (APs), oligomers and NIASs. The website warns that Matrix can only be used for risk assessment of authorised substances exempted from listing at the EU level according to Article 19, unless already listed in national law and subject to restrictions. It presents itself as a client-server application without the need for downloading. The tool builds on the equation exposure = migration × surface. the term ‘migration’ is either an experimental value or a calculated one (worst-case or migration modelling). It is based on data from five MSs (Germany, Spain, France, Italy and the United Kingdom). Each surface table (for each MS) consists of 51 food classes and 77 packaging materials. It is sponsored by five associations (CEFIC-FCA, EUPC, FPE, PlasticsEurope, and Giflex) and is freely available online. Updates are also fundamental to the value of this tool for its continued use.

Matrix is a web-based exposure tool for risk assessments of NLSs and NIASs to be performed under Article 19 of Commission Regulation (EU) No 10/2011 on plastic materials

Belgian authorities — CoE Database Exposure Assessment Tool

The Database of Substances known by the Member States of the Council of Europe and used in FCMs is an initiative of the Belgian authorities. This database is owned and managed by a public institution, the Belgian Scientific Institute for Public Health (WIV-ISP). Belgium received a mandate from the CoE to maintain and expand the database via an advisory group that will frame the contents and the use of the database. The database is accessible for the CoE MSs’ delegates and is accessible to public bodies and enterprises for a yearly fee.

The database consists of a compilation of lists of known substances that are or were used in FCMs. The lists are a compendium of the Swiss ordinance (Swiss ordinance on materials and articles (817.023.21) (2005).), the EU plastic regulation, resolutions of the CoE (On paper and board, coatings, silicones, rubber, cork stoppers, ion exchange and adsorbent resins), the list from the EFSA ESCO group and previous lists from the SCF (SCF lists from the note for guidance for petitioners for authorisation of FCM substances – 30 July 2008 – synoptic document SANCO D3/LR(2003)). Assessments and relevant data on substances are based on structural alerts relationships (Toxtree, Derek).

The plastics sector also uses Matrix for NLSs in plastics.

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