What are Documents of Compliance in Food Processing?

When it comes to food contact surfaces such as cleaning tools and handling equipment, compliance with regulatory standards is essential for ensuring food safety. In the United States, the FDA’s Code of Federal Regulations (CFR) Title 21, Part 110, Subpart C outlines specific requirements for materials that come into contact with food. According to these rules, all food-contact surfaces must be corrosion-resistant, made from non-toxic materials, and designed to withstand the conditions they will face during use, including exposure to food, cleaning agents, and sanitizers.

Although there is no mandatory requirement to test finished products for FDA compliance, it is common practice to provide documentation proving that the base materials used in food contact tools meet the necessary standards. This helps ensure transparency and builds trust with customers and auditors.

However, companies operating in the European Union are subject to stricter regulations. Under Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011, every food contact material (FCM) must undergo migration testing to confirm its safety for food use. These regulations require thorough testing and proper documentation to ensure that harmful substances do not migrate from the tool into the food.

What Are Migration Tests?

Migration testing involves evaluating how much of a substance—such as chemicals or compounds—can transfer from the material of a tool into the food it comes into contact with. For example, if a brush is made of blue plastic or has green bristles, each of these components must be tested separately. The maximum allowed migration is typically 10 mg/dm² for overall migration, though this can vary depending on the type of food and the nature of the substance involved.

Specific migration limits are also set for individual substances, which are outlined in Annex I of the EU regulation. Each substance has its own maximum allowable limit, and these must be carefully reviewed to ensure full compliance.

Documentation Requirements

According to Regulation (EU) No 10/2011 – Annex IV, a declaration of compliance must include several key elements:

• Identification details of both the company issuing the declaration and the manufacturer of the product.
• A list of all materials used and confirmation that they meet EU regulations.
• Results from migration tests and evidence that they conform to the required standards.
• Information about the intended use of the product, including the type of food it is designed for and the temperature and time limits for safe usage.

These documents serve as a critical part of the supply chain, helping food processors make informed decisions about the tools they use in production facilities. While the FDA does not mandate such detailed documentation, having it can significantly strengthen a company's food safety program and improve its credibility in the market.

Importance of Unique Compliance Documents

Each product must have its own unique compliance document unless it is made from the exact same composition. For instance, two brushes made with the same type of plastic and bristles can share one compliance document. However, if the color of the material changes—such as moving from blue to red—the composition is considered different, and a separate document is required.

To obtain these documents, it’s important to request them directly from your equipment manufacturer. A generic compliance statement is not sufficient for meeting European standards. If you're a Remco Product customer, reach out to our customer service team, and we’ll provide you with the necessary documentation for your specific tools.

Sources

Smith, Debra. “Are your cleaning tools food safe?” *Vikan*, 2015. http://ust.vikan.com/media/1288/food_hygiene_int_article_en_0615.pdf.

“Union Guidance on Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food as regards information in the supply chain.” *European Commission Health and Consumers Directorate-General*, 2013. https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_plastic-guidance_201110_reg_en.pdf.

Grosmans, Sonja; Thomis, Nadine. “Food Contact Materials EU No. 10/2011 legislation.” *Intertek*, 2012. http://www.intertek.com/events/2012/hes/eu-no-10-2011-for-plastic-food-contact-materials-webinar/slides/.

e-CFR. “Title 21: Food and Drugs, Part 110, Subsection C.” *U.S. Government Publishing Office*, 2016. http://www.ecfr.gov/cgi-bin/text-idx?SID=114e23c93d8ac137c1f2103395d974c8&mc=true&node=pt21.2.110&rgn=div5#sp21.2.110.c.