EDQM Technical guide

In mid-May 2021, European directorate for the quality of medicines & healthcare (EDQM for short) released the first edition of "Food Contact Paper and Paperboard Materials and Products" Technical Guidelines to fully respond to the consumption of possible contaminants in food contact paper and paperboard materials and products The challenge of consumer safety has improved the coordination of the safety management of food contact paper and cardboard materials and products in European countries. The guidance document was drafted by the European Committee on Food Contact Materials and Products (CD-P-MCA) and has been solicited from the public in 2020

The guidelines mainly consist of two parts. The first part quotes the decision of the Council of Europe (CoE) CM/Res(2020)9. This part of the resolution was passed at the 1385th meeting of ministerial representatives on October 7, 2020.

The principle is to better protect human health by supplementing food contact materials and products that are not covered by European regulations or other measures. The main content includes 10 parts

1. Purpose and scope: Supplement the food contact material and product regulations that are not covered by European regulations or other measures, and apply to all food contact materials and products within the scope of the revised resolution

2. Definition: Including the definition of food contact, officially assessed substances, total release (ORL), total migration (OML), QM, QMA, etc.

3. General requirements: should comply with regulations (EC) 1935/2004 and (EC) 2023/2006 or relevant national regulations

4. Risk assessment: The safety of the materials used in food contact materials and products should be assessed according to the internationally recognized scientific principles of risk assessment, which can refer to the EFSA guidelines. The assessment should also consider impurities and known or foreseeable reactions and degradation products. When the composition, production process is changed or new scientific or other data is obtained, the risk assessment should be re-assessed

5. Labeling: When materials and products that have not been in contact with food are on the market, they should be labeled in accordance with Article 15 of Regulation (EC) No. 1935/2004 or other relevant national regulations to ensure product safety and proper use. Labels should be clear and should not mislead consumers

6. Traceability: According to Article 15 and Article 17 of Regulation (EC) No. 1934/2004 or other relevant national regulations, it is necessary to ensure the traceability of food contact materials and products at all stages

7. Good manufacturing practices: Food contact materials and products should be produced in accordance with (EC) No. 2023/2006 or other relevant national regulations. In appropriate circumstances, consideration may also be given to assigning good manufacturing practice guidelines by the Trade and Manufacturers Association without prejudice to any applicable Member State legislation

8. Compliance documents: including the requirements of 8.1 supporting documents and 8.2 declaration of conformity

9. Compliance testing: use scientific methods (including modeling or worst-case calculations, etc.) to verify whether food contact materials and products comply with relevant regulations and restrictions

10. Technical guidelines: The technical guidelines cover specific and detailed material requirements and principles related to the safety and quality of food contact materials and articles. They are published by EDQM and updated regularly by CD-P-MCA when necessary.

The EDQM guidelines sort out and clarify the substances of high concern in food contact paper, such as mineral oil, o-benzene, PFAS, etc., and stipulate the corresponding limits and testing methods. Its release will lead relevant companies and regulatory agencies to do a good job in food contact paper And risk control of cardboard materials and products.

And before the EU enacts corresponding mandatory regulations, it has become an important basis for the quality and safety management of food contact paper. Therefore, relevant companies exporting to the EU should do a good job of monitoring and control in advance to reduce trade disputes and compliance risks caused by unqualified products.

IQTC has been paying attention to and carrying out the analysis and risk research of the monitoring indicators listed in the guide, and has cooperated with market supervision agencies and industries to carry out risk monitoring of related indicators for many times. Methods and standards for the determination of residues and migration of fluorinated polyfluorine, chloropropanol and other substances of high concern and pollutants.

For example, we can carry out the determination of PFOS, PFOA, and other PFAS residues and migration based on GB 31604.35 and chromatographic mass spectrometry. In particular, the research and development of liquid-phase-tandem mass spectrometry (LC-MS/MS) combined with gas-phase-tandem mass spectrometry (GC-MS/MS) can test 34 kinds of more common PFAS and other 4 kinds of organic fluoride residues And the amount of migration, the detection limit of the method is low.

Leading the formulation of the first domestic standard for the determination of mineral oil in paper products, SN/T4895-2017 "Determination of mineral oil in food simulants of paper and paperboard for food contact materials-Gas chromatography".

Leading the formulation of the mandatory standard GB 31604.52-2021 "National Food Safety Standard, Food Contact Materials and Products-Determination of Aromatic Primary Amine Migration".

Related scientific research results are published in domestic and foreign journals such as Food packaging &Shelf life, Molecular, Food contaminant & Additive, providing efficient technical services and professional solutions for compliance and safety management in the industry

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