In the European Union (EU), water-based inks used as part of food contact materials must adhere to a series of stringent regulations and standards to ensure their safety for food. These regulations primarily fall within the EU’s framework for Food Contact Materials (FCM) regulations, encompassing both general and specific material-oriented provisions.

1. EU Food Contact Materials Regulation: EC 1935/2004
   The fundamental regulation for food contact materials in the EU is Regulation (EC) No 1935/2004 of the European Parliament and of the Council. This regulation applies to all materials and substances that come into contact with food, including water-based inks. Its core requirement is to ensure that all food contact materials, particularly water-based inks, do not pose any risk to food safety under normal conditions of use.

Key Requirements:

• Safety: All food contact materials, especially water-based inks, must ensure that they do not adversely affect food under normal and intended conditions of use, including chemical migration, toxicity, and sensory properties (such as taste and odor).
• Non-migration: The components of water-based inks must not migrate into food, and chemicals in the inks cannot permeate into the food. The EU has established “Migration Limits,” and if certain components in the ink exceed these limits, the ink cannot be used for food packaging.
• Overall Compliance: Even if each component of the water-based ink meets EU standards, the final ink product must undergo an overall compliance assessment to ensure it does not pose potential risks when in contact with food.

2. Specific Regulation for Food Contact Materials in the EU: EC 10/2011
   For plastics and coating materials that come into contact with food (such as plastic components or additives in water-based inks), the most critical regulation is Regulation (EU) No 10/2011 of the Commission. This regulation pertains specifically to plastic food contact materials, covering the chemical composition, migration testing, and approval procedures for plastic materials and coatings (e.g., printing inks).

Key Requirements:

• Approval of Food Contact Substances: All chemicals used in food contact applications (such as pigments, resins, solvents in inks) must comply with the standards specified in EU 10/2011 and pass the EU approval process. In particular, the EU conducts rigorous assessments of the chemical components involved in inks to ensure they do not pose hazards to food.
• Migration Testing: For coatings and inks, especially those involving packaging materials for food, chemical migration testing must be conducted. This testing determines whether substances in the ink migrate into food and whether the migration levels comply with the EU’s migration limits.
• Ingredient List: Manufacturers of water-based inks need to submit detailed ingredient lists and migration data of chemicals to regulatory authorities to prove their products’ compliance.

3. Assessment of Chemicals and Additives: EFSA Guidelines
   The European Food Safety Authority (EFSA) is the primary assessment body for the safety of food contact materials. EFSA has issued several guidance documents for assessing and confirming the safety of food contact materials, including water-based inks. These guidelines provide methodologies for risk assessment of different types of materials and chemical components, including toxicological assessments, migration testing, and safety assessments for long-term use.

Key Requirements:

• Toxicological Assessment: All chemical components in food contact inks (such as solvents, pigments, resins) must undergo toxicological assessments by EFSA. EFSA evaluates whether these components pose risks to consumer health based on available scientific data.
• Migration Assessment: EFSA requires migration testing based on simulated use conditions (such as high temperatures, acidic or alkaline environments) to ensure that components in the ink do not migrate into food during contact.
• Safety Assessment for Use: For specific applications (such as packaging materials directly in contact with food), EFSA provides detailed assessment procedures to ensure the safety of inks and other materials over long-term use.

4. Specific Prohibitions and Limits on Substances
   The EU has imposed strict restrictions on the use of certain harmful substances, particularly in food contact materials. These restrictions are typically outlined in specific regulations to ensure that certain potential harmful substances (such as toxic pigments, solvents, heavy metals) in water-based inks are not used in food packaging materials.

Key Requirements:

• Prohibited Substances: The EU prohibits the use of certain substances harmful to humans (such as certain heavy metals, volatile organic compounds) in water-based inks.
• Migration Limits: Specific migration limits have been established for certain harmful substances (such as toxic solvents, heavy metals, and certain pigments). If the migration level of a component in the ink exceeds the specified limit into food, the ink does not comply with EU regulations and cannot be used for food packaging.

5. Declaration of Compliance for Food Contact Materials
   To demonstrate that water-based inks comply with EU regulations, manufacturers must provide a Declaration of Compliance (DoC) for their products. This declaration confirms that the ink meets the requirements of Regulations EC 1935/2004 and EU 10/2011 and has passed all necessary safety and migration tests.

Key Requirements:

• Declaration of Compliance: Manufacturers must provide an official declaration of compliance for their water-based inks, stating that the ink complies with all EU regulations for food contact materials. The declaration typically includes detailed documents such as migration test reports, ingredient lists, and toxicological assessment reports.
• Continuous Compliance: Even if the ink product has passed initial compliance checks, manufacturers must ensure ongoing compliance with the latest regulatory requirements. If changes occur in the ink’s composition or production process, manufacturers must reassess and update the declaration of compliance.

6. Labeling and Traceability Requirements
   In the EU, all materials used in food contact, including water-based inks, must have appropriate labeling indicating their compliance with relevant regulations. Additionally, manufacturers must ensure traceability for each batch of material produced and sold, enabling prompt action in the event of a food safety issue.

Summary
The EU’s regulation of water-based inks is quite stringent, especially when these inks are used for food packaging. Ink manufacturers must comply with regulations such as EC 1935/2004 and EU 10/2011 to ensure that the ink’s components do not pose any risks to food safety. Through rigorous chemical assessments, migration tests, and toxicological evaluations, the EU ensures that water-based inks meet safety standards in practical use, protecting consumer health. In terms of compliance for food contact materials, manufacturers must provide declarations of compliance and adhere to all relevant labeling, traceability, and approval procedures.