Multiple aspects of a food product are regulated in the European Union: the product composition and its communication; its safety and hygiene; its process and the process facility where the product is produced; diverse traceability aspects in the supply chain. There are horizontal and vertical laws which apply to food groups or individual ones. EU Food Comply specializes in EU mandatory documents and entry requirements for industrially processed foods. Its services are based on more than 20 years of experience serving the food industry. They cover practical questions on product, process, documents, procedures, border issues, training and guidance, and also deal directly with national and EU regulatory authorities.
EU Market Entry Documents & Issues
Assists with the preparation and problem-solving of obligatory legal and technical documents and procedures needed for entry of food products into the European Union market. Deals directly with food inspectors and authorities to solve issues, establish mandatory documents, submission and follow up, find local assistance, on-site representation.
Product Validation and Legal Check
Inspectors and other authorities may request various types of evidence regarding your food e.g., compliance documents, product composition and label questions, evidence that the food product is appropriate for a specific target group; that the food product can be legally marketed in the European market; that a claim can be substantiated; and so forth. Legal Check and Validation Services assist in providing the necessary arguments, and dealing with authorities.
Assists and guides companies with European food regulatory procedures, such as presentation of mandatory documents, pre-market approval, contact with authorities or EFSA, replying to questions, or problem-solving at points of entry into a member state.
EU Food Authorisations
Certain foods and food ingredients and their communication require prior approval before they can be marketed in the European Union. EU Food Authorisations assist with pre-market approval and getting the needed authorization for legal marketing in the European Union. See also: Novel foods, additives, claims
Food Product Label
Checks food product label in conformity with EU labelling regulations. Includes ingredient list (declaration), product claims, permitted additives, allergen declaration.
Additives and Ingredients
Additives and ingredients used in foods are regulated in the EU. Our services combine regulatory affairs and technological aspects of: Formulation: check additive and ingredient status and requirements (type, level, product suitability); establish which additive or ingredient may be used as replacement; guidance with product reformulation; project management of local recipe and reformulation work at European product development organisations. Authorization: New additives require pre-market approval. We assist with establishing regulatory status, gathering facts, preparing pre-market approval documents, submitting documents, procedure guidance and follow up. See also: Food Dossier, Project Management
Services offered on enzymes, processing aids, extraction solvents and gases used in foods are similar to those on Additives and Ingredients (link).
Some processes of food materials are regulated in the European Union. Our Food Processing Regulatory Services assists companies with technological-regulatory exploration of status, requirements, alternatives, industrial approach. This service is provided by industrial food technologists who have full understanding of regulatory aspects.
Several types of claims can be made on foods in the European Union. Claims related to product quality and composition, nutritional and health properties, designation of origin and geographical indication, specific target groups, and so forth. Pre-market approval is often necessary. Claim substantiation (proof of claim) may be obligatory. Food Claims services help with advice, guidance and support in documentation and procedures, dealing with authorities as well as training and guidance of food businesses. Our team has obtained food claims before and deal with EFSA and authorities. See also: Food Dossier, The Functional Foods Dossier
‘New foods’ to the European consumer are defined and regulated under the Novel Foods regulation. This covers new ingredients, new foods and new technologies. Pre-market authorization or notification are required. Our Novel Foods Service assists with questions, document preparation/submission/follow up, dealing with authorities as well as training and guidance of food businesses. We help obtain with substantial equivalence and authorisations for legal market entry; prepare for the safety assessment and the safety dossier; submit and follow up procedures; provide guidance for in-company work. See also: Food Dossiers
A set of EU food laws regulate genetically modified (GM) foods. GM foods services assist companies with advice, document preparation, dealing with authorities and training. See also: Food Dossiers, EU Food Authorisations
Food for Specific Groups (FSG) Services
Assistance with regulatory and science questions and documents to underpin foods for FSG foods. These are foods for very specific target groups such as babies, infants and young children, foods for special medical purposes and total diet replacement for weight control. In this service, our team bridges regulatory affairs with nutritional science and food technology.
Protection of Food Products in the European Union
EU law allows the protection of certain aspects of food products. These include geographical, origin, innovation and novelty (newness). Laws include protected denominations and intellectual property laws. We provide advice, help explore options, carry out specific fact-finding, manage legal protection projects, deal with documentation and authorities.
Products requiring pre-market approval require the preparation of a legal/scientific dossier. Examples are the safety dossier, claim dossier, additive dossier, and so forth. The contents of the dossier depend on its purpose, and cover different aspects. Dossier preparation require practical industrial know-how and experience to successfully integrate the needed disciplines; fulfil obligatory requirements effectively; collaborate with authorities in an adequate way; and succeed in obtaining the intended authorisation more rapidly and cost-effectively. See also: EU Food Authorisations, Additives, Processing, Food Claims, Novel Foods, GM Foods, Processing Aids, Protected Designations, Functional Foods Dossier
Food Regulatory Exploration and Regulatory Updates
This service researches the various aspects of a specific food regulatory issue: present and upcoming food laws; how companies deal with the issue; possible technological solutions; market information. It serves as a strategic update for decision making.
Food Regulatory Project Management
This service provides project management support in Western Europe. It uses our experience and know-how in contracting-out (outsourcing) product work in various countries. Assists food businesses with partner selection; contract negotiation; project design, management and implementation. See also: Technical Project Management