SAFEGUARDS | FoodNO. 070/16

SafeGuardS Edible Birdnest

On March 11 2016, the European Commission published Regulation (EU) 2016/355 [1], amending Annex III to Regulation (EC) No 853/2004 [2], concerning the specific requirements for gelatin, collagen and highly refined products of animal origin intended for human consumption.

A pure natural protein with a variety of applications, gelatin is a healthy ingredient in cookery and food manufacturing. Gelatin intended for use in food comes from the partial hydrolysis of collagen produced from the bones, hides, skins, tendons and sinews of animals including fish and poultry.

The EU is highly dependent on imports of raw materials for the production of gelatin and collagen. Food business operators must ensure that raw materials for the production of gelatin and collagen for human consumption come from sources that meet the public and animal health requirements, according to Union legislation. This means that before being placed on the market within the EU, all the above raw materials should be subjected to specified treatments, must comply with relevant residue limits and be verified using the most appropriate analytical method and most recently validated methods.  

Annex III to Regulation (EU) No 853/2004 is amended as follows:

  • Raw materials that have not undergone any preserving treatment other than chilling, freezing or quick-freezing must come from establishments registered or approved pursuant to Regulation (EC) No 852/2004, on the hygiene of foodstuffs [3] or in accordance with this Regulation

  • The following treated raw materials of the production of gelatin and collagen such as bones, hides and skins of farmed ruminant animals, pig skins, poultry skins, wild game hides and skins coming from establishments under the control of and listed by the competent authority may be used the specific treatment in accordance with this regulation

  • Raw material for the production of gelatin and collagen for human consumption for which animal health certification is required, the raw materials must be transported directly to the establishment at the place of destination

  • Food business operators must ensure finished product of gelatin and collagen that complies with the residue limits set out in the following table

Table 1

Residue Limit (ppm)
As 1
Pb 5
Cd 0.5
Hg 0.15
Cr 10
Cu 30
Zn 50
SO2 (European Pharmacopoeia, latest edition) 50
H2O2 (European Pharmacopoeia, latest edition) 10
  • The production process for collagen, all ruminant bone material derived from animals born, reared or slaughtered in countries or regions with a controlled or undetermined Bovine Spongiform Encephalopathy (BSE) risk, must ensure that all bone material is finely crushed and degreased with hot water, washed and treated with dilute hydrochloric acid. If it’s over a period of at least two days, the treatment must be followed by pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion

  • Moreover, food business operators manufacturing highly refined products of animal origin such as chondroitin sulfate, hyaluronic acid, other hydrolyzed cartilage products, chitosan, glucosamine, rennet, isinglass and certain amino acids, must ensure the treatment of the raw material used eliminates any animal or public health risk

This Regulation shall enter into force 20 days after its publication.

What do the changes mean?

Food business operators must ensure that raw materials and finished products of gelatin and collagen, including highly refined products intended for human consumption, must comply with the specific requirements of the Regulation that has been amended. For more information, or to discuss your testing, analysis and certification requirements contact a food safety expert, such as SGS.

SGS is committed to keeping you informed of regulation news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions including analytical tests, audits, certifications, inspections, and technical support. We continually invest in our testing, capability, and state-of-the art technology to help you reduce risk, and to improve food safety and quality. For more information, please visit our website:

For enquiries, please contact:

Naovarat Dachprasat
Food Technical Support Center

t: +66 2683 0541 ext 2168

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