欧盟委员会发布监测食品及食品接触材料中的矿物油碳氢化合物的指导文件

COMMISSION RECOMMENDATION （EU） 2017/84 of 16 January 2017
 
　　on the monitoring of mineral oil hydrocarbons in food and in materials and articles intended to come into contact with food
 
　　（Text with EEA relevance）
 
　　THE EUROPEAN COMMISSION,
 
　　Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,
 
　　Whereas:
 
　　（1）Mineral oil hydrocarbons （MOH） are chemical compounds derived mainly from crude oil, but also produced synthetically from coal, natural gas and biomass. MOH can be present in food through environmental contamination, lubricants for machinery used during harvesting and food production, processing aids, food additives and food contact materials. Food grade MOH products are treated in a way that the mineral oil aromatic hydrocarbons （MOAH） content is minimised.
 
　　（2）In 2012 the Scientific Panel on Contaminants in the Food Chain （ConTAM Panel） of the European Food Safety Authority （EFSA） concluded （1） that the potential human health impact of groups of substances among the MOH vary widely. MOAH may act as genotoxic carcinogens, while some mineral oil saturated hydrocarbons （MOSH） can accumulate in human tissue and may cause adverse effects in the liver. As some MOAH are considered mutagenic and carcinogenic, it is important to organise monitoring of MOH to better understand the relative presence of MOSH and MOAH in food commodities that are major contributors to dietary exposure.
 
　　（3）As migration from food contact materials such as paper and board packaging is suspected to contribute significantly to the total exposure, monitoring should include pre-packaged food, the packaging material and the presence of functional barriers, and equipment used for storage and processing. Certain parameters may increase the migration of MOH from packaging into food, such as storage time and storage conditions. As MOH are easier to detect in high quantities, the sampling strategy should take account of such parameters when their migration is highest.
 
　　（4）To ensure reliability of the obtained analytical data, Member States should ensure the availability of suitable analytical equipment and gain sufficient experience in the analysis of MOH both in food and in food contact materials before generating analytical results.
 
　　（5）To ensure the uniform application of this recommendation, the European Union Reference Laboratory for Food Contact Materials （EU-RL） should provide further guidance to the competent authorities of the Member States and other interested parties, including guidance on information that could be collected during investigations as well as methods of sampling and analysis,
 
　　HAS ADOPTED THIS RECOMMENDATION:
 
　　1. Member States should, with the active involvement of food business operators as well as manufacturers, processors and distributors of food contact materials and other interested parties, monitor the presence of MOH in food during 2017 and 2018. The monitoring should cover animal fat, bread and rolls, fine bakery ware, breakfast cereals, confectionery （including chocolate） and cocoa, fish meat, fish products （canned fish）， grains for human consumption, ices and desserts, oilseeds, pasta, products derived from cereals, pulses, sausages, tree nuts, vegetable oils, as well as food contact materials used for those products.
 
　　2. To ensure uniform application of this recommendation and in order to generate reliable and comparable results of the monitoring, specific guidance developed by the EU-RL in the context of this Recommendation （‘the guidance’） should be followed. As such guidance does not exist yet, the Member States should collaborate with the EU-RL to jointly develop that guidance in accordance with their needs for developing analytical capabilities.
 
　　3. Member States should perform food sampling in accordance with the provisions laid down in Commission Regulation （EC） No 333/2007 （2）。 Sampling should include a proportionate number of pre-packaged foods. Sampling of food contact materials should be carried out in accordance with the best practices appropriate for specific materials or articles as reflected in the guidance. Further possible sources of MOH related to the use of other food contact materials in the supply chain, such as during storage or processing, should be investigated where there is a clear indication that these are contributing to the presence of MOH. The sampling of pre-packaged food should focus on commodities that are closer to the end of the minimum date of durability, and where storage or processing takes place at relatively warm conditions.
 
　　4. The samples should be analysed as marketed. For pre-packaged food, the level of mineral oil hydrocarbons should be determined both in the food and in the food contact material if that is the suspected source of detected MOH. Particular attention should be paid to the differences between MOSH and MOAH and to the interpretation of the analytical results to ensure that the generated data are reliable and comparable. Member States which intend to analyse the presence of MOSH and MOAH in foods and food contact materials may request technical assistance of the EU-RL for Food Contact Materials.
 
　　5. Where MOH are detected in food, Member States should carry out further investigations in the food business establishments in order to determine the possible source or sources. The investigations should, wherever possible, cover the systems operated by the food business operator that could affect or control contamination （e.g. production and processing methods, Hazard Analysis and Critical Control Points （HACCP） or similar systems or measures implemented to prevent such presence）。
 
　　6. Where MOH are detected in or originate from food contact materials, Member States should collect data on the food contact material （e.g. type and composition of the packaging material, presence of functional barrier, shelf life of the packaged food） and carry out further investigations in the establishments of the manufacturers, processors and distributors of food contact materials to establish the systems operated by the businesses concerned （e.g. production and processing methods of food contact material, and documentation required under Commission Regulation （EC） No 2023/2006 （3） on good manufacturing practices） as indicated in the guidance.
 
　　7. Member States, food business operators, manufacturers, processors and distributors of food contact materials and other interested parties should provide to EFSA the monitoring data expressed on whole mass basis with the information and in the electronic reporting format as set out by EFSA for compilation into a single database. They should preferably provide the monitoring data by 1 October 2017 and subsequently by 1 October 2018. The last results should be provided by 28 February 2019. Potentially available occurrence data from 2016 that has not yet been provided should be transmitted in accordance with the same modalities at the earliest opportunity.
 
　　Done at Brussels, 16 January 2017.
 
　　For the Commission
 
　　Vytenis ANDRIUKAITIS
 
　　Member of the Commission