Food contact surfaces like cleaning and material handling tools must comply with the FDA’s rules about what they can contain and how they must be designed. FDA CFR21 110 Subpart C, states that “Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents.”
There currently isn’t an obligation to test finished products to comply with FDA regulations, however, it is a generally accepted practice to provide documents that show the base materials of food contact tools are FDA compliant.
But, companies that trade with Europe must follow a much stricter set of documentation laws. According to Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011, each food contact material (FCM) needs to undergo migration testing and be declared safe for food use.
Each base material—whether it’s the blue plastic used in a brush or the green bristles used on a broom—is put through migration testing. Migration testing reveals how much of any or a particular substance (such as harmful chemicals/compounds from the base materials) can be transmitted from the tool’s material to the food products. The maximum permitted quantity (QM) left behind in the food product is most often 10 mg/dm2 for overall migration limits (the total amount of migrated material left behind), but that figure changes when infant food or volatile substances are in play.
Specific migration limits, which consider the total amount of one specific substance that’s left behind, must be checked against Annex I for the maximum limit of each substance’s limit. The maximum amount allowed depends on the substance.
According to Regulation (EU) No 10/2011 – Annex IV, each declaration of compliance must contain the following:
- Identifying information for the business issuing the declaration, and the business that manufactures the product
- The materials used in the product, and confirmation they all conform to EU’s regulations
- Migration test results, and that they conformed to the standard
- Product information about what type of food the tool is meant to be used with, and the time/temperature it can safely be used at
For more specific information, read Regulation (EU) No 10/2011 – Annex IV here.
Use of documents of compliance
There must be one document of compliance for each product, excepting those made out of the same exact composition, which can share documentation. For example, one document for a blue push broom and a blue scrubber, as long as the plastic and bristles were made out of the same materials, is acceptable. However, one document for a blue and a red scrubber is insufficient to meet the requirements, since the color dye changes the product’s material composition.
This documentation is designed to give food processors the information they need to safely use tools in their production facilities. Though the FDA doesn’t require this type of documentation, it can greatly enhance your food safety plan.
To obtain these documents, request them from your equipment manufacturer. Make sure that each document is unique to the material it’s made of. One generic document of compliance isn’t enough to comply with European regulations. For Remco Product customers, email our customer service department at email@example.com, and our representatives will get you copies of the documents you need.
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.