Publication
Imports: Highly Refined Products
From Department of Agriculture, Food and the Marine
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1. The following are the highly refined products of animal origin intended for human consumption, listed in Regulation (EC) 853/2004 that have conditions specified therein:
a) chondroitin sulphate;
b) hyaluronic acid;
c) other hydrolysed cartilage products;
d) chitosan;
e) glucosamine;
f) rennet;
g) isinglass;
h) amino acids that are authorised as food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council (1);
i) food flavourings that are authorised in accordance with Regulation (EC) No 1334/2008 of the European Parliament and of the Council (2);
j) fat derivatives
2. The raw materials used for the manufacturing of the highly refined products must be derived from:
a) animals, including feathers thereof, which have been slaughtered in a slaughterhouse and the meat of which have been found fit for human consumption following ante-mortem and post-mortem inspection, or
b) fishery products complying with Section VIII, or
c) rendered fats and greaves complying with Section XII, or wool, if these products are submitted to one of the following processes:
i. transesterification or hydrolysis at a temperature of at least 200 °C, under corresponding appropriate pressure, for at least 20 minutes (glycerol, fatty acids and esters);
ii. saponification with NaOH 12M: — in a batch process at 95 °C for three hours; or — in a continuous process at 140 °C 2 bars (2 000 hPa) for eight minutes; or
iii. hydrogenation at 160 °C at 12 bars (12 000 hPa) for 20 minutes. Human hair may not be used as a source for the manufacture of amino acids.
3. The use of human hair is not permitted in the manufacture of amino acids.
4. The highly refined product must have been produced in accordance with the conditions laid down in:
a) Regulation (EU) 2016/429 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption
b) Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the european food safety authority and laying down procedures in matters of food safety
c) Regulation (EC) No 852/2004 on the hygiene of foodstuffs
d) Regulation (EC) No 853/2004 laying down specific rules for food of animal origin
e) Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products
f) Commission Delegated Regulation (EU) 2022/2292 supplementing Regulation (EU) 2017/625 with regard to requirements for the entry into the Union of consignments of food-producing animals and certain goods intended for human consumption
1. Consignment of highly refined products shall only be authorised for entry into the union from Third Countries or regions thereof:
a) in the case of highly refined products derived from ungulates, the third countries or regions thereof that are listed in Annex XII of Commission Implementing Regulation (EU) 2021/405;
b) in the case of highly refined products derived from fishery products, the third countries or regions thereof that are listed in Annex IX of Commission Implementing Regulation (EU) 2021/405;
c) in the case of highly refined products derived from poultry, the third countries that are listed in Annex XIII of Commission Implementing Regulation (EU) 2021/405.
2. The raw animal material from which the product is derived must come from an establishment approved by the EU to produce fresh meat of the relevant species or fishery product.
See lists at: Non-EU countries authorised establishments (europa.eu) .
3. The establishment of origin of the highly refined products must be an approved establishment, except for the production of highly refined products of animal origin referred to by HS headings 2930, 2932, 3503, 3507 or 3913 of Part Two of Annex I to Regulation (EEC) No 2658/87;
4. Highly refined products derived from amino acids must comply with Regulation (EC) No. 1333/2008 on food additives.
5. Products derived from bovine, ovine and caprine animals must meet the relevant requirements of Regulation (EC) No. 999/2001, which lays down the rules for the prevention, control and eradication of TSEs. Commission Decision 2007/453/EC categorises countries according to their BSE risk.
6. Iceland, Norway, Switzerland and Liechtenstein have international agreements with the EU which means that they implement EU veterinary legislation in relation to the movement of animal products. Animal products from these countries must comply with the same requirements applying to animal products from EU Member States and are therefore not subject to veterinary checks.
1. Highly refined products shall be presented at a Community Border Inspection Post accompanied by a veterinary health certificate, drawn up in conformity with the Model HRP (Chapter 46 of Annex III of Commission Implementing Regulation (EU) 2020/2235)
2. The certifying veterinarian should ensure that only the relevant paragraphs and, where appropriate, additional guarantees and/or special conditions applicable to exporting country are included.
1. Consignments of highly refined products entering the EU must be inspected at an EU-approved Border control Post (BCP) where Member States' official veterinarians ensure they fulfil all the requirements provided for in the EU legislation.
2. The person responsible for the load being imported (the importer or a customs agent acting on their behalf) must give the BCP at the intended point of entry advance notification of the arrival of the consignment.
3. There is a required minimum pre-notification notice period of at least 24 hours’ notice in advance of the consignment’s arrival.
4. Failure to submit correct documentation within this timeline may result in significant delays in the consignment being processed through the Border Control Post.
5. Pre-notification is given by the submission of Part 1 of the Common Health Entry Document (CHED-P), as is laid down in Commission Implementing Regulation (EC) No. 2019/1715, through the online TRACES NT system.
6. Copies of other supporting documentation associated with the consignment should be submitted at this time as well - such as the Health Certificate, Invoice, Packing list etc.
1. Providing all the documentation has been submitted correctly and within the correct timeframes, a large proportion of the documentary check can be commenced in advance of the consignment’s arrival. This includes examination of the veterinary certificate and other documents accompanying a consignment.
a) Please note the original hard copy of the health certificate must travel with the consignment and will be checked and held at the BCP at the point of entry into the EU.
2. Provided all is in order with the documentary check, the consignment will then be subject to an identity check at the BCP to ensure it identifies with the consignment that was declared in the documentation
3. A proportion of consignments will be selected for a full physical inspection with/without sampling as appropriate.
4. Upon satisfactory completion of the required checks, the decision is entered in Part 2 of the CHED which must accompany the consignment to the first place of destination referred to in the CHED.
5. If the consignment does not meet the import requirements, the consignment may be rejected and either re-exported or destroyed.