Food of animal origin, update of Annex III to Regulation (EC) 853/04

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On 12.4.21, the European Commission adopted the proposed Delegated Regulation – C (2021) 199, updating Annex III to Regulation (EC) 853/04.

The update aims to provide more flexibility regarding hygiene requirements for animal products. With the aim of resolving some issues that in practice have revealed difficulties in implementation. Without sacrificing high food safety standards.

Annex III to Regulation (EC) 853/04.

Annex III to Regulation (EC) 853/04 of the European Parliament and of the Council, establishes specific hygiene rules for various foods of animal origin.

In order to maintain a high level of food safety for consumers, these rules must be kept up to date taking into account experience gained from implementation, technological developments and their practical consequences and in changing consumption patterns.
Therefore, the following changes have been introduced in this delegated regulation.

1) Slaughtering and animal welfare

Introducing greater flexibility for slaughtering cattle and horses on the farm of origin for animal welfare reasons and to avoid risks to the handler (e.g., in the case of neurotic animals), under strict hygienic conditions and under official supervision. This action will support the continuous improvement of animal welfare standards, as called for by the European Green Deal in the Farm to Fork strategy.

Improving animal welfare is one of the actions proposed by the Commission’s DG Agri for a fair, healthy and environmentally friendly food system under the
Green Deal
Europe. Changes in meat consumption patterns must be considered, with increasing demand from both farmers and consumers to allow the slaughter of certain domestic ungulates on the farm of origin to avoid possible problems related to animal welfare and the safety of transporters and caretakers.

Outside the cases of emergency slaughter, at the present time, domestic ungulates must be slaughtered in a slaughterhouse approved under Article 4(2) of Regulation (EC) 853/04 to ensure compliance with the hygiene requirements set out in Chapters II and IV of Section I of Annex III of that Regulation.

The competent authorities of member states may allow mobile slaughterhouses to make animals suffer less and avoid the stress of transport. These mobile structures can be placed in all appropriate locations, including farms, where groups of healthy animals can be slaughtered.

Also, in other circumstances, transporting certain animals may create a risk to the handler or animal welfare. It is therefore appropriate to allow slaughter and bleeding on the farm of origin for a limited number of domestic animals of the bovine and porcine species and domestic solipeds (donkeys and horses, ed.). This practice should, in any case, be subject to strict conditions to maintain a high level of food safety of meat derived from such animals.

Domestic animals of the bovine and porcine species and domestic solipeds slaughtered on the farm of origin must be accompanied by an official certificate attesting to compliance with hygiene requirements for slaughter. The corresponding official certificate is provided for in Regulation (EU) 2020/2235.

2) Stomach, head and paw management solutions.

Resolution of practical difficulties/inconsistencies in the handling of stomachs for rennet production, handling of heads and legs, including temperature and conditions for storage and preservation.

Rennet is a complex of enzymes used in the production of some cheeses. It is collected from the stomachs of young ruminants. Based on the experience of food business operators, the specific hygiene requirements for stomachs for rennet production in Annex III, Chapter IV, Section I, point 18(a) of Regulation (EC) 853/04 should be amended to optimize the collection of rennet from young sheep and goats. In particular, such stomachs should be allowed to leave the slaughterhouse without first being emptied or cleaned.

On the other hand, technological developments have led to an increasing demand for processing outside the slaughterhouse of heads and feet of domestic ungulates, by skinning and/or scalding and depilation, in specialized establishments recognized for such processing. As a practical consequence, the heads and feet of domestic ungulates should be allowed to be transported to these establishments under certain conditions that ensure food safety. Therefore, paragraph 18(c) of Chapter IV of Section I of Annex III of Regulation (EC) 853/04 should be amended.

3) Role of the veterinarian in emergency slaughter.

Aligning the role of the official veterinarian in emergency slaughter with the new requirements of Delegated Regulation (EU) 2019/624.

According to Article 4 of Commission Delegated Regulation (EU) 2019/624, the official veterinarian may carry out ante-mortem inspection outside a slaughterhouse in case of emergency slaughter of domestic ungulates. Point 2 of Chapter VI of Section I of Annex III of Regulation (EC) 853/04 requires the exit of a veterinarian for ante-mortem inspection in case of emergency slaughter outside the slaughterhouse. This requirement should be modified to be consistent with Article 4 of Delegated Regulation (EU) 2019/624 and refer instead to the official veterinarian.

4) Retail meat freezing

Consensus to freeze retail meat for the purpose of facilitating food donation, thereby preventing food waste and promoting food security, in line with the goals set out in the ‘
Farm to Fork
‘ of the Commission.

On 9/27/18, the European Food Safety Authority (EFSA) adopted a second scientific opinion on approaches to be followed in risk analyses for certain small retail establishments and food donations.

This opinion recommends freezing at the retail level as an additional tool to ensure safe redistribution of food to those in need. Facilitating safe practices for food donation, prevents food waste and contributes to food security, in line with the goals set out in the strategy ‘Farm to Fork‘ of the Commission and with its overall goal of establishing a fair, healthy and environmentally sound food system as part of the Green Deal European. Freezing food can be an important way to ensure safe redistribution by food banks and other charities.

The freezing of meat is currently not allowed in the case of retail activities because meat intended for freezing must be frozen without undue delay after slaughter or in accordance with point 4 of Chapter VII of Section I of Annex III of Regulation (EC) 853/04 with regard to domestic ungulates and point 5 of Chapter V of Section II of that Annex with regard to poultry and lagomorphs (hares and rabbits, ed.). Therefore, freezing of meat should be allowed in the case of retail activities under certain conditions to ensure the safe distribution of food donations.

5) Changing the definition of veterinarian

Removal of the definition of ‘approved veterinarian’ in the section on farmed game because the definition of such veterinarian was merged with the definition ofofficial veterinarian by Regulation (EU) 2017/625.

Regulation (EC) 854/04 provides the definition of ‘Approved Veterinarian’. Regulation (EU) 2017/625, in repealing Regulation (EC) 854/04, defined ‘official veterinarian’, the notion of which includes ‘authorized veterinarian’. Therefore, Regulation (EC) 853/04 should now be updated accordingly.

6) Hygiene in game collection centers.



Introduction of hygienic conditions


specific in game collection centers.

The specific hygiene requirements for the production and placing on the market of mammalian meat from farmed game mammals in Section III of Annex III of Regulation (EC) 853/04 apply only to meat from cervids or suidae. Similar requirements should, however, also apply to meat from other farmed game mammals, such as llamas, to avoid possible food safety risks related to changing consumption patterns and increased consumption of such meat.

Bodies and viscera of hunted game animals may be transported and stored in a collection center before transportation to a game processing center. To ensure the food safety of such meat, specific hygiene rules should be introduced for the handling and storage of these bodies and viscera in such collection centers by amending the hygiene requirements for wild game in Annex III, Section IV of Regulation (EC) 853/04.

Wild game must be transported as soon as possible to a game collection center after examination by a qualified person in accordance with point 3 of Chapter II of Section IV of Annex III of Regulation (EC) 853/04 with regard to large wild game and point 3 of Chapter III of that section with regard to small wild game, to allow cooling within a reasonable time after killing. This requirement should also apply to game in which no examination has been carried out.

7) Extension of hygiene requirements

Extension of hygiene requirements for farmed game, snails and frog legs to new animal species/families placed on the market for human consumption.

Specific hygiene standards for the preparation of frog legs are provided for in Section XI of Annex III of Regulation (EC) 853/04, which applies only to frog legs of the species Rana sp. (ranidae family), according to the definition of frog legs provided by Section 6.1 Annex I of that regulation: ”Frog legs‘: the hind parts of the body dissected transversely behind the front limbs, eviscerated and skinned, from the species Rana sp. (ranidae family);

In the same Section XI are the specific hygiene rules for snails provided by Section 6.2 Annex I of that regulation: ‘Snails‘ means terrestrial gastropods of the species Helix Pomatia L., Helix Aspersa Muller, Helix lucorum and species belonging to the family Achatinidae.

Due to changes in eating habits, frog legs and snails of other species are also produced and placed on the market for human consumption. The specific hygiene standards for these animal species should, therefore, be extended to other species (of ranidae and edible terrestrial gastropods, ed.) to ensure the safety of food derived from these species.

8) Preservation of greaves and animal fats.

Adapting new storage conditions for greaves and animal fats to technologies such as vacuum packing.

Section XII of Annex III of Regulation (EC) 853/04 establishes specific temperature requirements for the storage of greaves for human consumption. Technological developments have developed new packaging techniques, such as vacuum packaging, for which no specific temperature requirements are required to ensure the safety of food derived from cracklings.

The temperature conditions should therefore be deleted while the food business operator should ensure the safety of food derived from greaves through good hygiene practices and procedures based on the principles of hazard analysis and critical control points (HACCP) in accordance with Article 5 of Regulation (EC) 852/04.

9) Biotoxin analysis in shellfish.

Exclusion of pectenotoxins from the list of marine biotoxins for analysis in live bivalve molluscs based on an EFSA opinion.

Live bivalve molluscs placed on the market may contain marine biotoxins that exceed the limits in point 2 of Chapter V of Section VII of Annex III of Regulation (EC) 853/04. However, EFSA concluded in its opinion on Biotoxins in Shellfish – Pectenotoxin Group that there are no reports of adverse effects in humans associated with toxins of the pectenotoxin group (PTX). In addition, PTX group toxins are always present in shellfish in association with OA group toxins.

This association is the basis for the decision to consider the two groups of toxins together in the European regulation. The CONTAM Panel, consisting of scientific experts dealing with contaminants in the food chain, concluded that because the PTX group of toxins does not share the same mechanism of action as the OA group of toxins, they should not be included in the regulatory limits proper for toxins in the okadaic acid (OA) group. Therefore, the reference to PTX should be deleted from paragraph 2(c), Chapter V of Section VII of Annex III of Regulation (EC) 853/04.

10) Displacement of bivalve molluscs.

Establish a specific model of the registration document that must accompany the movement of live bivalve molluscs after harvest and until they are placed on the market.

Point 3 of Chapter I of Section VII of Annex III of Regulation (EC) 853/2004 stipulates that whenever a food business operator moves a batch of live bivalve molluscs between establishments, the batch must be accompanied by a registration document.

In order to harmonize the information required in item 4 Chapter I of Section VII of Annex III of Regulation (EC) 853/04, a common model of the registration document for the movement of live bivalve molluscs between establishments should be established. In addition, it is a common practice that batches of bivalve mollusks may be sent to intermediate operators, so the document record should include this possibility as well.

In accordance with point 1 of Part A of Chapter IV of Section VII of Annex III of Regulation (EC) 853/04, live bivalve molluscs must be washed with clean water free of mud and accumulated debris before purification begins. However, to save water, washing clean bivalve mollusks should not be mandatory. Item 1 of Part A of Chapter IV of Section VII should be amended accordingly.

11) Rules for echinoderms.

Alignment of the rules for echinoderms set in Delegated Regulation (EU) 2019/624 with the derogation limitations set by the Parliament and Council in Regulation (EU) 2017/625.

Article 11 of Delegated Regulation 2019/624 provides that the classification of production and relaying areas is not necessary in relation to the collection of pectinids and marine gastropods and holoturoids that are not filter feeders, if the competent authorities carry out official controls on these animals at auction sales, dispatch centers, and processing establishments.

Chapter IX of Section VII of Annex III of Regulation (EC) 853/04 should be amended in order to allow harvesting of Holothuroidea outside classified production areas.

12) Hygiene on fishing and refrigerated vessels.

Setting temperature requirements specific for fishery products handled on board fishing vessels, specific hygiene requirements for reefer vessels regarding transport temperature and cold storage maintenance, requirement on board vessels that containers used for fishery products not be used for other purposes.

Vessels should be designed and constructed so as not to cause contamination of fishery products with bilge water, sewage, smoke, fuel, oil, grease or other undesirable substances. In addition, holds, tanks or containers used for the storage, cooling or freezing of fishery products should not be used for purposes other than the storage of fishery products.

Freezer ships and refrigerated vessels should be equipped with freezing equipment with sufficient capacity to freeze as quickly as possible, continuously and with as short a period of thermal shutdown as possible, so as to achieve a core temperature of not more than -18 °C. Storage rooms should not be used for freezing products. The same requirements for freezing and storage equipment should also apply to cold rooms on the ground.

Part I of Chapter I and Part B of Chapter III of Section VIII of Annex III of Regulation (EC) 853/04 should therefore be amended.

As a result of recent fraud concerning tuna initially frozen in brine at -9° C and intended for canning but diverted to be consumed as fresh fishery products, it should be clarified in point 7 of Part II of Chapter I of Section VIII of Annex III of Regulation (EC) 853/04 that whole fishery products initially frozen in brine at -9° C and intended for canning even if further frozen to a temperature of -18° C should not have a destination other than the canning industry.

Livers and eggs of fishery products intended for human consumption should be stored under ice, at a temperature approaching that of melting ice, or should be frozen. Livers and eggs should also be allowed to be refrigerated under conditions other than ice, at a temperature approaching that of melting ice.

Accordingly, point 6 of Part II of Chapter I of Section VIII of Annex III of Regulation (EC) 853/04 should be amended to allow that livers and eggs of fishery products for human consumption can also be refrigerated not only under ice but under different refrigeration conditions.

Melt water should be prevented from remaining in contact with fishery products, in containers used for shipping or storage of bulk products of fresh fishery products prepared and stored under ice. To this end, for hygienic reasons, the melt water should be drained. To this end, point 4 of Part A of Chapter III of Section VIII of Annex III of Regulation (EC) 853/04 should be updated.

Fabrizio De Stefani

On the cover, the character Doc Véto, by cartoonist Achdé (Hervé Darmenton, Lyon)

Papers

Draft Delegated Regulation – Ares (2020) 5183349 (288.3 KB – PDF – 9 pages in English) https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12353-Food-safety-animal-products-revision-of-specific-rules-

Attachment – Ares (2020) 5183349 (415.5 KB – PDF – 14 pages in English) https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12353-Food-safety-animal-products-revision-of-specific-rules-

Fabrizio De Stefani

Irreverent veterinarian. Specialist in Hygiene of food of animal origin, master in Lean Health Care Management, Veterinary Public Health, Business Intelligence and Knowledge Management. AGENAS Area 4 Expert (Clinical, Organizational, Epidemiological, Social), Quality Management Systems Evaluator of the competent Authority for Food Safety (ASL, Regions), Head of the audit group (RGA) on Operators in the Food and Feed sector. Currently Director of the Food Hygiene Veterinary Service of ULSS N. 7 Pedemontana (Veneto)