Technical Regulation TR EAEU 040/2016 “On safety of fish and fish products” establishes mandatory safety requirements for fish, seafood and related food products placed on the market of the Eurasian Economic Union (EAEU).
The regulation covers product safety and the associated processes of production, storage, transportation, sale and disposal. It also establishes packaging and labelling requirements and aims to prevent misleading information about products.
Its scope includes processed and unprocessed fishery products obtained from aquaculture and aquatic biological resources of animal and plant origin.
Adopted: October 18, 2016.
Entered into force: September 1, 2017.
Scope of TR EAEU 040/2016
The regulation applies to fishery food products and the associated production and distribution processes. The applicable requirements depend on the product category, processing method and intended use, including whether the product is intended for general consumption or children’s nutrition.
Products and activities outside the scope
The regulation excludes certain products and activities, including:
- the breeding and cultivation of fish and other aquatic biological resources;
- specialised fish-based food products, except products intended for children’s nutrition;
- food supplements made from fish, aquatic invertebrates, aquatic mammals, algae and other aquatic plants;
- non-food products obtained from fish and other aquatic biological resources.
The complete scope and exclusions must be checked for the particular product. Exclusion from TR EAEU 040/2016 does not automatically exempt a product from other applicable requirements.
Conformity assessment
Depending on the product category, conformity assessment takes one of the following forms:
- EAC Declaration for products subject to declaration under the regulation;
- state registration for fish products intended for children’s nutrition, in accordance with TR CU 021/2011 On food safety;
- veterinary and sanitary examination for unprocessed food products of animal origin, including the relevant categories of live fish and live aquatic invertebrates.
The appropriate procedure must be determined before preparing the documentation and arranging testing.
Fish products intended for children’s nutrition
TR EAEU 040/2016 establishes additional requirements for fish products intended for children. These concern raw materials, production conditions, ingredients and product safety.
Fish products intended for infants under one year of age must be manufactured at specialised production facilities, in specialised workshops or on dedicated production lines.
The regulation prohibits the use of phosphates, flavour enhancers, benzoic and sorbic acids and their salts in fish products intended for children’s nutrition. Restrictions also apply to compound additives containing these substances and to colourants.
The assessment must take account of the product’s composition, intended age group, manufacturing conditions and state registration requirements.
Supporting documents
The required documentation depends on the product and conformity assessment procedure. It may include:
- a product description, composition and specifications;
- test reports demonstrating compliance with the applicable safety requirements;
- technical documentation describing the product and manufacturing process;
- information about the manufacturer and applicant;
- draft labels, packaging information and shelf-life specifications;
- the supply contract and accompanying documents for a specific batch;
- a quality management system certificate, where required by the selected scheme;
- other evidence required for declaration, state registration or veterinary and sanitary examination.
Documents must meet the language and submission requirements of the applicable procedure in the relevant EAEU Member State.
EAC marking and labelling
Products that meet the applicable requirements and have completed the required conformity assessment must bear the EAC conformity mark before being placed on the market.
Packaging, labels and accompanying information must comply with TR EAEU 040/2016 and other applicable regulations, including TR CU 022/2011 on food labelling and TR CU 005/2011 on packaging.
The EAC mark may only be applied when the product complies with all applicable technical regulations.
Validity of the EAC Declaration
The validity period depends on the declaration scheme and whether the declaration covers serial production or a specific batch:
- Scheme 3d: up to three years for serial production;
- Scheme 6d: up to five years for serial production;
- Scheme 4d: for a specific batch, taking account of the product’s shelf life.
The declaration must accurately identify the products, manufacturer and supply arrangements it covers.
TR EAEU 040/2016 On safety of fish and fish products — Russian text
