What should you look for in a Declaration of Compliance?

Regardless of whether you’re a food producer or a cleaning equipment distributor, you are entitled to see the food safety documentation on any plastic cleaning equipment you purchase.

In Europe, all plastic materials intended for use in contact with food or on surfaces in contact with food have to be accompanied by a Declaration of Compliance. But what should you look for in a Declaration of Compliance, and which information is mandatory?

Find out the nine items that have to be included in a Declaration of Compliance.

Do you want hazardous substances in your food products?

Well, the obvious answer is “no”.

But how do you make sure the plastic equipment you purchase for your food production setup doesn’t transmit unwanted substances into the food you produce, process or package? And how do you check all this?

The Declaration of Compliance (DoC) is the document in which Vikan as a plastic equipment supplier guarantees that our products comply with the relevant EU regulations and provide you with the right conditions for use to avoid your food products being affected by hazardous chemicals.

More and more auditors at food factories throughout Europe are also focusing on the right documentation being present in the DoC of Food Contact Materials. If such documentation isn’t available, this will usually result in a non-conformity during an audit.

In the following, I‘ve explained which items it’s important you check for in a DoC.

What’s a DoC?

A Declaration of Compliance (DoC) is required under Article 16 of the EU food contact materials Framework Regulation (EC) 1935/2004. More specific details can be found in Annex IV of the Plastics Regulation (EU) 10/2011. In short, every European manufacturer of plastic materials that come into contact with food must issue a DoC for the articles and products they supply.

More details on these regulations are available in the Vikan whitepaper Are Your Cleaning Tools Food Safe?.

For simplicity, the regulation (EC) 1935/2004 will be referred to as (EC) 1935/2004, and the Plastics Regulation (EU) 10/2011 as (EU) 10/2011.

Who needs to issue a DoC?

The requirement stretches across the entire supply chain—from chemical suppliers and intermediate plastic suppliers (like those providing granules and masterbatch), to manufacturers of finished plastic items (such as Vikan), distributors, and end-users.

Effective communication throughout this chain is essential. Each party must pass documentation one step forward and one step back.

For example, as a manufacturer of plastic tools, Vikan must obtain appropriate DoCs from intermediate suppliers. These documents help ensure that necessary steps, like migration analysis or calculations, are completed, thus confirming that the finished products comply with current regulations and are safe for food contact.

Based on this, a DoC is issued for each finished tool. This lets distributors and end-users know that they meet regulatory requirements and outlines the tools' intended uses.

What to Look for in a DoC

Wondering what must be included in a DoC and what’s important when using plastic cleaning tools in food processing? Here are the nine key items required by Annex IV of (EU) 10/2011:

1. Business Operator Info
   The official name and address of the company issuing the DoC.

2. Manufacturer or Importer Info
   The official name and address of the company manufacturing or importing the plastic article. If the issuer and manufacturer/importer are the same, this can be combined with item 1.

3. Product Identity
   Identifiable information, such as item numbers and material types. The DoC should specify the type of polymer and any additional materials used (adhesives, inks, coatings, etc.).

   EU guidance states that products with significantly different compositions must each have their own DoC. Vikan complies by issuing one DoC per item number. Any stainless steel or aluminum components are also listed.

4. Date of Declaration
   The date the DoC was issued. Regular reviews and updates are recommended. Vikan updates DoCs at least once a year or when there are regulatory changes.

5. Compliance Confirmation
   A statement that the product meets the requirements of (EC) 1935/2004 and (EU) 10/2011. This includes confirmation that only approved substances were used and that the product complies with the overall migration limit (OML). The declaration may also include test conditions and references to good manufacturing practices as outlined in Regulation (EC) 2023/2006.

6. Restricted Substances
   Disclosure of any substances listed in Annex I or II of (EU) 10/2011 with specific migration limits (SMLs). The DoC should confirm these limits are not exceeded under intended use. Vikan bases this on either migration testing or calculations.

7. Dual-Use Additives
   Identification of any substances also authorized as food additives or flavorings under Regulations (EC) 1333/2008 or 1334/2008.

8. Usage Specifications
   Includes:

   • Types of food the item can contact (aqueous, acidic, alcoholic, fatty, dry). Products tested with 10% ethanol, 3% acetic acid, and olive oil can be used with all food types.

   • Time and temperature conditions for use and storage.

   • Surface area-to-volume ratio used during testing, often expressed as dm²/ml.

9. Functional Barrier Statement (if applicable)
   Relevant only for multi-layer articles with a functional barrier. Confirms compliance with Article 13 or 14 of (EU) 10/2011, ensuring no hazardous substances migrate through the barrier.
   Vikan products do not use functional barriers of this type.

Summary

Understanding what belongs on a DoC makes it easier to ensure food-contact plastics are compliant and safe.

Vikan products are tested and documented to meet all legal standards. That means users can count on them to be food-safe and backed by the right paperwork.

DoCs for Vikan products can be found on the individual page of each of our products that are intended for food contact to help our customers stay prepared for audits.

Questions about a specific DoC or food-contact regulations? Contact our customer service at cs@vikan.com.