Food & Food Contact Materials
In a globalised world, food and food commodities crossing boarders is daily business. But of course this doesn't work without complying to certain standards.
Food Contact Materials
Considering their nature/definition and intended use conditions, food contact materials (FCM) (i.e. plastic, paper, board, printing ink, ceramic, wood, metal, cork, textiles, adhesives etc.) are meant to come directly (or indirectly) in contact with food.
Under certain conditions of use, for certain chemical substances present in the final FCM, the likelihood to migrate from the FCM into the food becomes a possibility, if not a real certitude.
Based on their toxicity, substances migrated into food are of key importance. These may represent a high risk as they could have a negative impact on human health. Therefore, a careful analysis/assessment, i.e. analytical determination of the migrated substances into food or food simulants, and the determination of the corresponding consumer exposure thereof, is a must.
Depending on the geographical area (e.g. EU, United Kingdom, USA, Canada, MERCOSUR ( = Mercado Común del Sur), China, Japan, Switzerland etc.) and the FCM type, one might need to apply for an authorisation in a given country/area in order to have a certain key FCM-substance included in an existing positive list.
& Maximum residue levels
Continuously increasing in global trade of food and feed between countries enhances the need for Import Tolerances (IT) as a rising number of countries are implementing regulations to control pesticide residues in imported goods by setting and enforcing Maximum Residue Levels (MRLs) for active ingredients.
When in the importing country no national MRL exists for an agricultural commodity/active ingredient combination, the active ingredient is not registered, or the detected residues exceed the set MRL for an imported crop, then import will only be possible upon submitting petitions (dossiers) to establish Import Tolerances. Based on the data provided in the submitted application, an Import Tolerance can be set. In case the active ingredient of interest is not authorised in the importing country yet, toxicology and metabolism data have to be provided in addition to the residue data and analytical methods for enforcement purposes.
Talk with our experts about your needs for Import Tolerances: not matter it it is IT setting in Taiwan, South Korea, Hong Kong, Singapore, Japan, Australia, USA, Russia, the EU or other countries. We are happy to share our knowledge.
Note: by the end of December 2021 all temporary MRLs set in South Korea will drop to 0.01 ppm. If this affects the trading of your crops you want to consider submitting Import Tolerance petitions to the Korean authority MFDS by March 2021 to allow for evaluation time before the full implementation of the Positive List System (PLS) at the end of next year.
For support with setting of international Codex MRLs and toxicological Endpoints get in touch with our experts to discuss your JMPR submissions.
Knowing your regulatory environment is essential to stay in the market: with a global network of affiliates, knoell keeps track of the developments concerning global regulations. Read more about our strategic and regulatory consulting solutions.
- Communication with authorities
- Portfolio management
Document Preparation for Food Contact Materials
- Compilation of full food contact application dossiers (petition dossiers) for authorisation in e.g. the EU (for both EU harmonised and non-harmonised FCM), United Kingdom, USA, Canada (voluntary system), MERCOSUR (= Mercado Común del Sur), China, Japan, Switzerland.
- Preparation and review of migration testing protocols, and corresponding draft reports, for EU-harmonised FCM (i.e. plastics FCM), EU non-harmonised FCM (i.e. paper, board, printing inks, etc.) as well as other geographical areas
- Preparation of Declaration of Compliance / Conformity (DoC) documents, based on the analysis and evaluation of targeted formulations
- Preparation of compliance documents with respect to Good Manufacturing Practice (GMP) requirements related to the manufacturing of FCM
- Preparation of toxicological testing protocols, and corresponding reports
Read more about our submission support services.
Preparation of Import Tolerance Petitions and Codex Dossiers
- Dossier preparation, compilation and submission (Toxicology and Residue Dossiers)
- Dietary exposure assessments and Risk Cup evaluations
- Scientific statements and argumentations
- Preparation of OECD study summaries
Food Contact Materials
- Check of compliance status in accordance with the existing positive listing
- Review of toxicological testing protocols and corresponding reports
- Literature search and evaluation
- Preparation of data gap analyses, in accordance with existing specific guidance documents, addressing all necessary data for full food contact application dossiers, including...
- Overall and specific migration data
- Worst case calculation (WCC) in the absence of migration data
- Impurity profiling, including identification and quantification of Non-Intentionally Added Substances (NIAS)
- Identification and quantification of (residual) Intentionally Added Substances (IAS) present in the final FCM or migrating into food/food simulant from the FCM
- Safety risk assessments of NIAS and non-listed IAS (where applicable) present in FCM
Import Tolerance Petitions and Codex Dossiers
- Data gap analysis
- Check of completeness (CoC)
- Supporting analyses for Import and Codex MRL planning
- Trade flow analysis (FAOSTAT, UN Comtrade)
Read more about technical and scientific support.
Study management and monitoring can be challenging tasks. Besides the various problems caused by complicated test substances, the right CRO needs to be identified for the required study and ideally you want a study to be performed in a way that it can be used for submissions in more than one country or region, if your business is international.
If you need customised study monitoring for your migration or toxicological testing or support with planning and monitoring of your residue trials, find out why knoell might be the right choice for you.
Good Manufacturing Practice (GMP) audits at the food contact materials and food contact articles manufacturing facility. That's something we can do for you, or we can support you with preparation for inspection. Further details are outlined here.
Benefit from our up-to-date expert training modules, seminars and workshops held on scheduled dates at our training premises, online or at a location of your choice and individually designed for you. Explore our knoell academy programme!