The use of food contact materials (FCM) is regulated in many parts of the world. In Europe, Framework Regulation (EC) No 1935/2004 lays down the general rules covering all food contact materials, whilst the Good Manufacturing Practice (GMP) Regulation (EC) 2023/2006 covers the methods and procedures under which the materials are produced. AG8大厅登录咨询与姊妹公司合作 傻瓜食品研究, supports FCM producers in meeting regulatory compliance requirements around the world.
Food contact materials are widely used in everyday life; from the devices used in food production, 在运输和销售过程中用来保存和保护食品的包装, 消费者用来准备和食用食物的器具, 咖啡师用来制作AG8大厅登录最爱的早晨咖啡的机器.
Foods vary widely in their type and chemical composition and different food contact materials may behave differently when they come in to contact with food. 大多数这些物质将它们的一些成分转移到食物中. Such constituents are often called migrants and it is the control of their presence in food that is the purpose of FCM legislation. 材料应该以足够的水平转移或迁移吗, 它可能会对人类健康产生影响或改变食物本身.
Framework Regulation (EC) No 1935/2004 and GMP Regulation (EC) 2023/2006 establish general safety requirements for all food contact materials. 然而，它们只提供一般的指导. Harmonized standards exist for plastics (including recycled plastics), ceramics, active & 智能材料和再生纤维素. 所有其他材料都在单个成员国级别进行管理. 适用于生产销往欧盟以外地区的产品的公司, individual nations, 或成群的国家, have their own specific regulations regarding acceptable migration levels and the mechanisms by which these regulations are implemented.
FCM producers are responsible for the regulatory compliance of their end products. 符合规定的证明, 包括遵守区域和特定类型的法规, 这类产品的合法使用是否需要.
为市场带来一种新的食品接触材料, to a new region, 用于一种新的食物类型, 或对既存产品采取补救措施, 是否复杂且耗时.
AG8大厅登录 can help
结合AG8大厅登录在工业化学品方面的优势, 毒理学与人类健康, 以及傻瓜食品研究在全球食品行业的专业知识, AG8大厅登录可以帮助原材料生产商, 转换器或食品包装在食品接触的所有方面的符合性, including:
- 准备QA, QC和相关文件
- 最终产品中物质的风险评估, 但不包括在授权化学品清单上
结合100年食品科学创新(傻瓜食品研究)，拥有近30年的国际监管专业知识(AG8大厅登录 Consulting), we support clients in all aspects of regulatory compliance for new food contact substances and materials. AG8大厅登录的目标是了解AG8大厅登录客户的目标和目的, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. Our team of experts is deadline-focused, responsive, committed and professional. AG8大厅登录对工作的保密性有极大的尊重, 较强的项目管理能力, 并注重与客户建立长期的合作关系.
Any material that food touches in the supply chain from farm to consumer is considered to be food contact. 这些材料包括以下产品类型:塑料, ceramics, recycled materials, 积极和智能的材料和物品, printing inks, 油漆和涂料, paper and board, adhesives, 再生纤维素, rubbers, silicones, epoxy materials, metals and alloys, glass, cork and wood, colorants, and pigments. AG8大厅登录可以建议您的公司必须遵守哪些规定, as well as undertake a risk assessment of substances present in your products.
遵从性声明(DOC)是一种书面文件, declaring that a particular product complies with the relevant EU regulation. In the EU, it is a mandatory requirement for business operators to provide a DOC for food contact plastics (including recycled plastics), 活性和智能材料, 陶瓷和再生纤维素薄膜. 对于其他类型的FCM, 例如纸张和墨水, a DOC is only mandatory in some European member states but does provide an excellent starting point for a compliance statement to satisfy your customer’s needs.
The EU plastics regulation (EU No 10/2011) also requires FCM manufacturers to provide customers with a written DOC for finished plastic materials and articles, 生产中间阶段的产品, as well as for the substances intended for the manufacturing of those materials and articles. Declarations of compliance do not need to be made available at the retail stage.
欧盟有一些世界上最高的食品接触安全标准, with legislation ensuring that food is safe for consumers regardless of the materials it comes into contact with in the supply chain. A key tool to ensure the flow of information to enabling swift reaction when risks to public health are detected is 食品和饲料快速警报系统.
Vital information exchanged through RASFF can lead to products being recalled from the market and actions placed upon the company supplying them.
这种情况会发生在你的产品上吗, AG8大厅登录 Consulting can examine the evidence and recommend remedial action to get your product back on the market as quickly as possible.
Migration testing is the experimental assessment of the migration (transfer) of components from food contact materials into the food. It is conducted under controlled and standardised laboratory conditions and is used to verify that products are compliant with the applicable regulations. Food contact regulations set out the migration limits based on a toxicological risk assessment, and suppliers of FCM must demonstrate that their products comply with the relevant overall migration limits (OML), specific migration limits (SMLs) and/or maximum permitted quantities (QMs).
AG8大厅登录 Consulting can manage migration testing for food contact materials should testing be required. Alternatively, we can often use mathematical calculations or computer models to avoid migration testing, 节省你的时间和金钱.
通知一个新的FCM, you will need to submit a package of information (called a dossier or notification) to the relevant regulatory authority. Although the exact information requirements vary between authorities the general principles are similar and involve supplying:
- A description of your new FCM, its intended use and how it is manufactured
- 迁移的数学估计, or actual migration measurements which are used to calculate consumer exposure
- Toxicological evidence which increases in scope and complexity as consumer exposure increases
- An explanation of why the FCM is safe in the intended use; and (sometimes)
信息需求是广泛而复杂的, 这意味着档案通常包含数百页. AG8大厅登录可以准备提交给EFSA的档案, 欧盟成员国当局, 美国食品及药物管理局和加拿大卫生部.