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Hygiene for food of animal origin

Hygiene for food of animal origin

Outline of the Community (European Union) legislation about Hygiene for food of animal origin

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Veterinary checks animal health rules food hygiene

Hygiene for food of animal origin

Document or Iniciative

Regulation (EC) No 853/2004 of the European Parliament and of the Council, of 29 April 2004, laying down specific hygiene rules for food of animal origin. [See amending act(s)].

Summary

Foodstuffs of animal origin listed in Annex I of the Treaty on the Functioning of the European Union may present microbiological and chemical hazards, necessitating the adoption of specific hygiene rules contributing to the completion of the internal market and ensuring a high level of public health protection. These rules supplement those laid down in Regulation (EC) No 852/2004 on the hygiene of foodstuffs, which primarily concerns the approval of operators.

GENERAL OBLIGATIONS

The provisions of this Regulation apply to unprocessed and processed products of animal origin, but not to foods consisting of both products of plant origin and processed products of animal origin, unless expressly indicated to the contrary. Furthermore, this Regulation does not apply to the retail trade or to primary production for private consumption, for which the provisions of the above-mentioned Regulation on the hygiene of foodstuffs are sufficient.

Registration and approval of establishments

Establishments handling products of animal origin must be registered and, where necessary, approved by the competent authority in their Member State. This does not apply to establishments engaged only in primary production, transport or storage of products not requiring temperature-controlled storage conditions, or retail operations not subject to the Regulation.

In accordance with Regulation (EC) 882/2004 on official controls performed to ensure the verification of compliance with feed and food law and with the provisions relating to animal health and animal welfare. Member States must keep up-to-date lists of approved establishments, which are given an approval number with additional codes indicating the type of products of animal origin manufactured.

Health marking and identification

Where required by the Regulation, products of animal origin must be given a health mark applied in accordance with Regulation (EC) No 854/2004 laying down specific rules on the organisation of official controls on products of animal origin intended for human consumption or, failing this, an identification mark applied to products before they leave the product establishment if their packaging and/or wrapping is removed or it is further processed in another establishment. This mark must be legible, indelible and clearly visible for the competent authorities, and must show the name of the exporting country and the establishment’s approval number where the operations took place. When applied in an establishment located within the European Union, the mark must be oval in shape and include the abbreviation CE, EC, EF, EG, EK or EY.

Imports from Non-EU Member Countries

The Commission draws up lists of Non-EU Member Countries from which imports of products of animal origin are permitted, in accordance with the Regulation (EC) 854/2004 on official controls. In principle, a third country may only be included on these lists if a European control has taken place in that country and demonstrates that the competent authority provides appropriate guarantees that their provisions comply with or are equivalent to European legislation.

Furthermore, Regulation (EC) 854/2004 provides that an establishment may only be included in these lists if the competent authority in the originating third country guarantees:

  • >that the aforementioned establishment, as well as any other establishment handling raw materials of animal origin used in the production of the products of animal origin concerned, comply with the relevant European requirements, specifically with those of Regulation (EC) 853/2004 or those which have been defined as equivalent to these requirements following the decision to include this third country in the relevant list, in accordance with Article 11;
  • >that an official inspection service in this country carries out monitoring of the establishments and makes available to the Commission, where necessary, all relevant information on the establishments providing raw materials;
  • >that this service has the power to prevent establishments from exporting to the Union in the even that they do not comply with the requirements detailed above.

When drawing up these lists, particular account is taken of:

  • the existing legislation of the third country, and the organisation and powers of the competent authority and the inspection services;
  • where applicable, the situation regarding animal health, zoonoses and plant health, as well as the procedures for notifying the Commission and the competent international bodies of animal or plant diseases which occur;
  • experience gained in relation to marketing vis-à-vis the third country and its collaboration in exchanging information, particularly on health risks;
  • the results of EU inspections/audits carried out in the country concerned;
  • the existence, in the third country concerned, of legislation on animal nutrition and programmes for monitoring zoonoses and residues.

By way of derogation, there are special provisions for imports of fishery products.

Food chain information

The Regulation also provides instructions to ensure that slaughterhouse operators receive food chain information on all animals except wild game.

SECTORAL APPROACH

In Annex II to the Regulation, a sectoral approach is taken to determining the specific hygiene provisions applicable to foodstuffs of animal origin.

In order to take account of traditional production methods, the competent authority may grant special conditions for applying the appropriate hygiene rules in the sectors concerned.

Meat of domestic ungulates

This section is concerned mainly with meat from domestic animals of the bovine, porcine, ovine and caprine species.

Animals for slaughter must be collected and transported carefully so as not to cause unnecessary distress. Animals showing symptoms of disease or from contaminated herds or flocks may not be transported, except with special authorisation.

Ante-mortem and post-mortem inspections must be carried out in accordance with the Regulation on official controls on products of animal origin intended for human consumption.

With a view to minimising the possibility of any contamination of meat, specific hygiene rules cover the following aspects:

  • construction and equipment of slaughterhouses;
  • the slaughter process in general and emergency slaughter in particular: stunning, bleeding, skinning, dressing and evisceration;
  • cutting and boning operations in cutting plants;
  • control of health marking of meat by an official veterinarian;
  • storage, transport and maturation of meat (temperature at which it is kept).

Meat of poultry and lagomorphs

The following provisions apply to meat of farmed birds and of rabbits, hares and rodents.

Poultry and lagomorphs must be collected and transported carefully so as not to cause unnecessary distress. Those showing symptoms of disease or from contaminated flocks may not be transported, except with special authorisation.

Ante-mortem and post-mortem inspections must be carried out in accordance with the Regulation on official controls.

Specific hygiene standards are laid down with the aim of minimising the possibility of any contamination of the meat produced, covering the following elements:

  • transport of birds to the slaughterhouse;
  • construction, design and equipping of slaughterhouses and cutting plants;
  • the slaughter process: stunning, bleeding, skinning or plucking, dressing and evisceration;
  • cutting and boning work;
  • poultry reared for the purpose of producing ‘foie gras’.

Meat of farmed game

Unless the competent authority considers them inappropriate, meat of farmed game coming from even-toed mammals (Cervidae and Suidae) must be produced and marketed under the conditions laid down for meat of domestic ungulates (see above).

The provisions relating to poultry meat will apply to the production and marketing of meat from ratites (flightless birds).

In the interest of animal welfare, the competent authority may, in certain circumstances, authorise the slaughter of farmed game at the place of origin instead of at an approved establishment.

Wild game meat

Specific hygiene provisions cover the following elements:

  • training of hunters in health and hygiene;
  • killing, evisceration and transport of wild game to an approved establishment;
  • game handling establishments.

Minced meat, meat preparations and mechanically separated/recovered meat (MSM)

This section does not apply to the production and marketing of minced meat intended for the processing industry, which is subject to the requirements for fresh meat.

Specific hygiene rules cover the following elements:

  • equipping and approval of production establishments;
  • raw materials used (or prohibited) in the production of minced meat;
  • production, conservation and use of minced meat, meat preparations obtained from minced meat, and mechanically separated meat (MSM);
  • product labelling.

Meat products

There are hygiene standards specific to meat products. Depending on the type of animal, they cover the raw materials which may not be used in the manufacture of meat products.

Live bivalve molluscs

With the exception of the provisions on purification, the following rules also apply to live echinoderms, tunicates and marine gastropods.

Live bivalve molluscs harvested from the wild and intended for human consumption must comply with high health standards applicable at all stages of the production chain:

  • production of live bivalve molluscs: three types of production area (Class A, B or C);
  • harvesting of molluscs and their transport to a dispatch or purification centre, relaying area or processing plant;
  • relaying of molluscs in approved areas under optimal conditions of traceability and purification;
  • essential equipment and hygiene conditions in dispatch and purification centres;
  • health standards applicable to live bivalve molluscs: freshness and viability; microbiological criteria, evaluation of the presence of marine biotoxins and harmful substances in relation to the permissible daily intake;
  • health marking, wrapping, labelling, storage and transport of live bivalve molluscs;
  • the rules applicable to pectinides harvested outside classified areas.

Fishery products

Fishery products caught in their natural environment may have to be handled for bleeding, heading, gutting and the removal of fins. They are then chilled, frozen or processed and/or wrapped/packaged on board vessels in accordance with the rules laid down in this section.

Specific hygiene requirements cover the following elements:

  • equipment and facilities on fishing vessels, factory vessels and freezer vessels: areas for receiving products taken on board, work and storage areas, refrigeration and freezing installations, pumping of waste and disinfection;
  • hygiene on board fishing vessels, factory vessels and freezer vessels: cleanliness, protection from any form of contamination, washing with water and cold treatment;
  • conditions of hygiene during and after the landing of fishery products: protection against any form of contamination, equipment used, auction and wholesale markets;
  • fresh and frozen products, mechanically separated fish flesh, endo-parasites harmful to human health (visual examination), and cooked crustaceans and molluscs;
  • processed fishery products;
  • health standards applicable to fishery products: evaluation of the presence of substances and toxins harmful to human health;
  • wrapping, packaging, storage and transport of fishery products.

Raw milk and milk products

As regards primary production of raw milk, the specific health requirements are as follows:

  • raw milk and colostrum must come from females of the species (cows, buffaloes, ewes, goats, other) which are in a good general state of health that do not show any symptoms of infectious diseases communicable to humans through the milk or colostrum and which are not suffering from any infection of the genital tract with discharge, enteritis with diarrhoea and fever, or a recognisable inflammation of the udder. The animals must not have any udder wound likely to affect the milk or the colostrum;
  • subject to further, more specific provisions, raw milk must comply with microbiological criteria and standards for plate count and somatic cell count.
  • milking, collection and transport of raw milk and colostrum must comply with clearly-defined hygiene rules in order to avoid any contamination. The same applies to persons involved, premises, equipment and utensils used in production.

The Regulation sets out the general hygiene requirements for heat-treated drinking milk and other milk products, dealing mainly with the preparation of pasteurised milk and Ultra High Temperature (UHT) milk.

Wrapping and packaging must be designed to protect milk and/or milk products from harmful effects of external origin. For control purposes, the labelling must clearly show the characteristics of the product, including where applicable the terms ‘raw milk’, ‘made with raw milk’, ‘colostrum’ or ‘colostrum-based’.

Eggs and egg products

At the producer’s premises and until sale to the consumer, eggs must be kept clean, dry, free of extraneous odour, protected from shocks and direct sunlight, stored and transported at an optimal temperature for conservation. They must be delivered to consumers within 21 days of laying.

The hygiene rules governing egg products (e.g. albumin) cover:

  • the availability of suitable rooms within approved production establishments in order to separate egg product manufacturing operations;
  • the raw materials used in egg products: conditions for using eggshells and liquid egg;
  • the manufacture of egg products in such a way as to avoid any contamination during production, handling and storage;
  • analytical specifications for various residues and for butyric and lactic acids;
  • labelling and identification marking.

Frogs’ legs and snails

Only approved establishments with the required facilities, having due regard to handling and preparation, may prepare and kill frogs and snails.

Frogs and snails which are found dead are not fit for consumption. The same applies to those considered to present a hazard on the basis of an organoleptic examination carried out by sampling.

Rendered animal fats and greaves

Hygiene standards for storage, preparation and preservation apply to establishments collecting or processing raw materials.

The hygiene rules in respect of rendered animal fats, greaves and by-products cover:

  • raw materials: these must come from animals deemed fit for consumption after inspection, consisting of adipose tissues or bones which are reasonably free from blood and impurities;
  • the originating establishment which must be registered or approved pursuant to Regulation 852/2004 and pursuant to this Regulation;
  • preservation during the collection, transport and storage of these raw materials;
  • the rendering methods: heat, pressure, decantation, prohibition of solvents;
  • the composition of animal fats;
  • the storage of finished products intended for human consumption.

Treated stomachs, bladders and intestines

In addition to the storage requirements for these products, specific hygiene rules govern the production and placing on the market of treated stomachs, bladders and intestines, as regards the animals they come from and the establishments where they are treated.

Only products which have been cleaned and scraped, then salted, heated or dried, and treated to avoid any new contamination, are suitable for human consumption. There are also rules on conservation, in particular the temperature of products that are not salted or dried.

Gelatine

The following raw materials, derived from animals declared fit for consumption after inspection and slaughtered according to the existing hygiene rules, may be used in the manufacture of gelatine which is to be used in foodstuffs:

  • bones, tendons and sinews;
  • hides and skins of farmed ruminant animals, pigs, poultry and wild game;
  • fish skin and bones.

Specific provisions apply to:

  • collection centres and tanneries authorised to supply raw materials;
  • the transport and storage of raw materials;
  • the gelatine manufacturing process;
  • the maximum limits for residues in finished products;
  • labelling.

Collagen

Collagen may be manufactured from the same raw materials as gelatine, with the exception of hides and skins that have undergone a tanning process.

Specific provisions also apply to:

  • collection centres and tanneries authorised to supply raw materials;
  • the transport and storage of raw materials;
  • the collagen manufacturing process;
  • the maximum limits for residues in finished products;
  • labelling.

BACKGROUND

This Regulation forms part of the ‘hygiene package’, a body of law laying down hygiene rules for foodstuffs, which, in addition to this Regulation, includes the following acts:

  • Regulation (EC) No 852/2004 defining the food safety objectives to be achieved, leaving food operators responsible for adopting the safety measures to be implemented in order to guarantee food safety;
  • Regulation (EC) No 854/2004 putting in place a Community framework for official controls on products of animal origin intended for human consumption and laying down specific rules for fresh meat, bivalve molluscs, milk and milk products.

The following acts supplement the Community legislation on food hygiene:

  • Regulation (EC) No 178/2002 laying down the general principles of food law. This Regulation explains the food safety procedures and establishes the European Food Safety Authority (EFSA);
  • Regulation (EC) No 882/2004 reorganising official controls on foodstuffs and feedingstuffs so as to integrate controls at all stages of production and in all sectors;
  • Directive 2002/99/EC laying down the conditions for placing products of animal origin on the market and the restrictions applicable to products from non-EU countries or regions of non-EU countries subject to animal health restrictions.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 853/2004

20.5.2004

OJ L 139 of 30.4.2004

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 219/2009

20.4.2009

OJ L 87 of 31.3.2009

Successive amendments and corrections to Regulation (EC) No 853/2004 have been incorporated into the basic text. This consolidated versionis for reference purposes only.

Related Acts

Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) 854/2004 [Official Journal L 338, 22.12.2005].
See consolidated version

Report from the Commission to the Council and the European Parliament on the experience gained from the application of the hygiene Regulations (EC) No 852/2004, (EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 on they hygiene of foodstuffs [COM(2009) 403 final – Not published in the Official Journal].
The Commission reviews the experience gained from the application of the aforementioned regulations. It presents the progress achieved and the difficulties encountered by all the interested actors in the implementation of the 2006 – 2008 hygiene package. It concludes that overall Member States have taken the necessary administrative and control steps to ensure compliance, but that there is still room for improvement in relation to implementation. The main difficulties identified are in relation to:

  • certain exemptions from the scope of the hygiene Regulations;
  • certain definitions laid down in these Regulations;
  • certain practical aspects concerning the approval of establishments handling foods of animal origin and the marking of such foods;
  • the import regime for certain foods;
  • the implementation of HACCP-based procedures in certain food businesses; and
  • the implementation of official controls in certain sectors.

This report does not suggest any detailed solutions. However, on the basis of the difficulties identified, the Commission will consider the need for any proposals to improve the food hygiene package.

Authorised food additives: general scheme

Authorised food additives: general scheme

Outline of the Community (European Union) legislation about Authorised food additives: general scheme

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Other

Authorised food additives: general scheme

Since 1990, all authorised food additives and their conditions of use have been harmonised at European level, in order to protect consumer health and guarantee the free movement of foodstuffs in the European Union (EU).

Document or Iniciative

Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives for use in foodstuffs intended for human consumption. [See amending acts].

Summary

Directive 89/107/EEC

The scope of the Directive covers food additives used as ingredients during the manufacture or preparation of food and which are part of the finished product and listed in one of the categories in Annex I (a “food additive” being any substance not normally consumed as a food itself, the intentional addition of which results in its becoming an ingredient).

The only substances which may be used as food additives are those included in the approved lists and then only under the conditions of use mentioned in those lists (e.g. preservatives, emulsifiers, sweeteners, raising agents).

The Council draws up:

  • a list of substances the use of which is authorised to the exclusion of all others;
  • a list of foodstuffs to which these substances may be added and the conditions under which they may be added, and restrictions which may be imposed in respect of technological purposes;
  • rules concerning substances used as solvents including purity criteria where necessary.

A special procedure permitting the Commission to legislate after consulting the Standing Committee on Foodstuffs applies to:

  • the drawing up of purity criteria;
  • where necessary, the methods of analysis needed to verify that the purity criteria are satisfied;
  • where necessary, the procedure for taking samples and the methods for the qualitative and quantitative analysis of food additives in and on foodstuffs;
  • other rules necessary to ensure compliance with the rule that only listed additives may be used.

Provisions for action by Member States on listed additives even if the additives which are considered for specific reasons to carry a health risk comply with the Directive.

Conditions for provisional authorisation by a Member State for the marketing and use on its territory of unlisted additives belonging to the categories listed in Annex 1 to the Directive in the light of scientific and technical progress, e.g. maximum limit of two years’ circulation.

Information requirements on labelling and packaging of additives for sale, for the consumer or for the manufacture of foodstuffs.

Directive 94/34/EC

By Directive 94/34/EC Member States are authorised to prohibit the use of certain additives in foodstuffs produced using traditional methods on their territories, provided the prohibition existed on 1 January 1992 and that the free movement of goods is not affected.

However, Member States are required to permit on their territory the production of non-traditional products in conformity with the Directives on additives.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Directive 89/107/EEC 28.12.1988 27.6.1990 OJ L 40 of 11.2.1989
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Directive 94/34/EC 10.9.1994 OJ L 237 of 10.9.1994
Regulation No 1882/2003 [adoption: codecision COD/2004/0237] 20.11.2003 OJ L 284 of 31.10.2003

Related Acts

Proposal of 28 July 2006 for a Regulation of the European Parliament and of the Council on food additives [COM(2006) 428 final – Not published in the Official Journal].

The future Regulation will harmonise all authorised additives added to food in one Community list, by including colours and sweeteners. It will also establish a common authorisation and evaluation procedure.
The Standing Committee on the Food Chain and Animal Health shall examine all additives which are already authorised and any new ones, and the European Food Safety Authority (EFSA) shall carry out a risk assessment on these products. To authorise a new additive or renew an existing authorisation, the assessment should show that the product is safe, technologically necessary, of benefit to the consumer and that the consumer is not being misled by its use.
The future Regulation will repeal all the provisions in force concerning additives (see below).

The rules on additives are based on:

  • Directive 89/107/EEC;
  • Directive 95/2/EC on food additives other than colours and sweeteners;
  • Directive 94/35/EC on sweeteners;
  • Directive 94/36/EC on colours;
  • and Decision No 292/97/EC (see below).

Decision No 292/97/EC of the European Parliament and of the Council of 19 December 1996 on the maintenance of national laws prohibiting the use of certain additives in the production of certain specific foodstuffs [Official Journal L 48 of 19.02.1997]
This Decision authorises certain Member States to apply legislation prohibiting the use of certain additives in the production, within their territory, of particular foodstuffs which are regarded as traditional. These exceptions do not contradict the provisions relating to agricultural products and foodstuffs as traditional specialities guaranteed.

Reports

Report [COM(2001) 542 final – Not published in the Official Journal]

Report from the Commission of 1 October 2001 on Dietary Food Additive Intake in the European Union.

Authorised sweeteners

Authorised sweeteners

Outline of the Community (European Union) legislation about Authorised sweeteners

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Other

Authorised sweeteners

The legislation stipulates the sweeteners which may be used in foodstuffs and their conditions of use. The list of authorised sweeteners (in the Annex to the Directive) is updated regularly according to the latest scientific advances in the field.

Document or Iniciative

European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners intended for use in foodstuffs [see Amending acts].

Summary

This Directive is a specific Directive arising from the framework Directive 89/107/EEC on food additives. It applies to food additives used to impart a sweet taste to foodstuffs, together with those for a particular nutritional use or for use as table-top sweeteners. It does not apply to foodstuffs with sweetening properties, such as honey.

Sweeteners are used to replace sugar in the production of energy-reduced foodstuffs, non-cariogenic foodstuffs or food without added sugars, for the extension of shelf life, as well as for the preparation of dietetic products.

Different sweeteners which may be placed on the market as well as their conditions of use in foodstuffs are specified in the Annex. The doses specified refer to ready-to-eat foodstuffs only.

Sweeteners cannot be used in foods for infants and young children mentioned in Directive 89/398/EEC, including foods for infants and young children who are not in good health, except if provided otherwise.

Member States are required to establish a system of regular surveys to monitor sweetener consumption. On the basis of this information, the conditions of use of sweeteners as laid down in this Directive may, if necessary, be amended.

Labelling of table sweeteners containing polyols and/or aspartame must bear the following warnings:

  • polyols: ‘over-consumption may have laxative effects’;
  • aspartame: ‘contains a source of phenylalanine’;
  • aspartame-acesulfame salt: ‘contains a source of phenylalanine’.

Sweeteners authorised by Community regulations must comply with the specific purity criteria defined by Directive 2008/60/EC.

References

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 94/35/EC

31.12.1995

31.12.1995: authorisation of trade in and use of products conforming to the Directive
30.6.1996: prohibition of trade in and use of products not conforming to the Directive

OJ L 237 of 10.9.1994

Amending act(s)

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 96/83/EC

26.2.1997

19.12.1997: authorisation of trade in products conforming to the Directive
19.6.1998: prohibition of trade in products not conforming to the Directive

OJ L 48 of 19.2.1997

Regulation (EC) No 1882/2003

20.11.2003

OJ L 284 of 31.10.2003

Directive 2003/115/EC

29.1.2004

29.7.2005

29.01.2006 (Products marketed before the Directive came into force)

OJ L 24 of 29.1.2004

Directive 2006/52/EC

15.8.2006

15.2.2008

OJ L 204 of 26.7.2006

Related Acts

Proposal for a Regulation of the European Parliament and of the Council of 28 July 2006 on [ final — Not published in the Official Journal].

The proposed Regulation will harmonise in a Community list all the authorised additives added to foodstuffs, including sweeteners and colours. The proposed Regulation will repeal all the provisions in force concerning additives.
Codecision procedure (COD/2006/0145)

Proposal for a Regulation of the European Parliament and of the Council of 28 July 2006 establishing a common authorisation procedure for food additives, food enzymes and food flavourings [ — Not published in the Official Journal].
Requests for the authorisation of additives will be incorporated into a harmonised authorisation procedure for additives, enzymes and flavourings.
In order to authorise a new additive or renew an existing authorisation, the evaluation must show that the product is safe, technologically necessary, provides benefits to consumers and is not misleading as to its use.
The European Food Safety Authority will carry out a risk assessment for new authorisation requests.
The Commission will be assisted by the Standing Committee on the Food Chain when granting new authorisations for the placing on the market of food additives, food enzymes and flavourings.
Codecision procedure (COD/2006/0143)

Specific purity criteria

Directive 2008/60/EC [Official Journal L 158 of 18.6.2008] (specific criteria of purity concerning sweeteners for use in foodstuffs).

Labelling

Directive [Official Journal L 88 of 05.04.1996].
Council Directive of 29 March 1996 amending Commission Directive 94/54/EC concerning the compulsory indication on the labelling of certain foodstuffs of particulars other than those provided for in Council Directive 79/112/EEC.
This Directive requires food labels to include relevant information on the sweeteners contained in foodstuffs. It also stipulates that warnings should appear on the labels of foodstuffs containing aspartame or polyols.

Directive [Official Journal L 27 of 31.1.2008].
Other compulsory indications apart from those provided for in Directive 2000/13/EC must be shown on the labels of certain foodstuffs (for example: ‘packaged in a protective atmosphere’, ‘contains a source of phenylalanine’, ‘contains liquorice’, etc.) in order to better inform the consumer.

Traceability and labelling of GMOs

Traceability and labelling of GMOs

Outline of the Community (European Union) legislation about Traceability and labelling of GMOs

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal nutrition

Traceability and labelling of GMOs

Document or Iniciative

Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC [See amending act(s)].

Summary

The European Union sets out a framework for guaranteeing the traceability of GMOs throughout the food chain, including in processed foods in which the production methods have destroyed or altered the genetically modified DNA (e.g. in oils). These rules apply not only to GMOs to be used in food, but also those intended to be used in crops (e.g. seeds).

Objectives

The European Union has two main objectives:

  • to inform consumers through the compulsory labelling, giving them the freedom to choose;
  • to create a “safety net” based on the traceability of GMOs at all stages of production and placing on the market. This “safety net” will facilitate the monitoring of labelling, the surveillance of the potential effects on human health or the environment and the withdrawal of products in cases of risk to human health or the environment.

GMOS

This Regulation covers:

  • all products which consist of GMOs or which contain them (this includes fields as diverse as the products, which are intended for entry into the human or animal food chain, products destined for industrial processing for uses other than consumption (e.g. in the production of biofuel) or even products destined to be used ornamentally (e.g. in the production of cut flowers));
  • foodstuffs and animal feed products made from GMOs.

Labelling and traceability

All the products covered by this Regulation are subject to compulsory labelling, which shall enable consumers to be better informed and will offer them the freedom to choose to buy products consisting of, containing or made from GMOs.

The specific requirements of this Regulation related to labelling shall not apply in isolation as these rules are in addition to the following rules which also concern labelling:

  • the general labelling rules applicable to foodstuffs generally intended for human consumption (Directive 2000/13/EC);
  • the general labelling rules provided for the marketing of feed (Regulation (EC) No 767/2009);
  • the specific labelling rules applicable to GMO food and feed (Regulation (EC) No 1829/2003).

Traceability enables GMOs and their products to be traced throughout the production chain. This system is based on the transmission and holding of information by each operator.

GMOs or products containing GMOS

Operators must transmit the following information in writing:

  • an indication that the products consist of or contain GMOs;
  • the unique identifiers assigned to the GMOs.

If the product is a mixture of GMOs, the industrial operator may submit a declaration of use of these products, together with a list of the unique identifiers assigned to all the GMOs used to constitute the mixture.

This information must also be held for five years.

The operators who place on the market a pre-packaged product consisting of or containing GMOs must, at all stages of the production and distribution chain, ensure that the words “This product contains genetically modified organisms” or “Product produced from GM (name of organism)” appear on a label of the product. In the case of products, including in large quantities, which are not packaged and if the use of a label is impossible, the operator must ensure that this information is transmitted with the product. It may take the form of accompanying documents, for example.

Products produced from GMOs

When placing a product on the market, the operator must transmit the following information in writing to the operator receiving the product:

  • an indication of each food ingredient produced from GMOs;
  • an indication of each raw material or additive for feedingstuffs produced from GMOs;
  • if there is no list of ingredients, the product must bear an indication that it is produced from GMOs.

This information must also be held for five years.

GMO adventitious presence threshold

All food or feed products, including those intended directly for processing are subject to the labelling obligation when they consist, contain or are made from GMOs. Only traces of GMOs may be exempt from this obligation if they do not exceed the threshold of 0.9 % and if their presence is adventitious and technically unavoidable.

The Member States carry out measures for the inspection and monitoring of products, including sampling and quantitative and qualitative analyses of food and feed. These measures entail the Member States being able to withdraw from the market a product that does not meet the conditions laid down in this Regulation.

Context

This Regulation harmonises the traceability measures laid down in the legislation, particularly Directive 2001/18/EC on the deliberate release of GMOs in the environment.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1830/2003

07.11.2003

16.01.2004

OJ L 268, 18.10.2003

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1137/2008

11.12.2008

OJ L 311, 21.11.2008

The successive amendments and corrections to Regulation (EC) No 1830/2003 have been incorporated into the original text. This consolidated versionis of documentary value only.

Plastic materials and articles

Plastic materials and articles

Outline of the Community (European Union) legislation about Plastic materials and articles

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Plastic materials and articles

Document or Iniciative

Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food.

Summary

This Regulation establishes specific requirements applicable to the manufacture and marketing of plastic materials and articles intended to come into contact with food. These requirements supplement the general provisions laid down in Regulation (EC) No 1935/2004 on materials and articles used for the packaging of food.

Materials

This Regulation applies to plastic materials and articles intended to come into contact with food. These materials and articles and parts thereof may be composed:

  • exclusively of plastics;
  • of several layers of plastics; or
  • of plastics combined with other materials.

This Regulation does not apply to ion exchange resins, rubber, or silicones.

The provisions on printing inks, adhesives or coatings supplement the requirements laid down in this Regulation.

Placing on the market

Plastic materials and articles intended to come into contact with food must comply with:

  • the requirements for use, labelling and traceability set out in Regulation (EC) No 1935/2004;
  • the good manufacturing practice defined in Regulation (EC) No 2023/2006;
  • the compositional and declaration requirements set out in this Regulation.

Authorised substances

Only the substances included in the list set out in Annex I may be intentionally used in the manufacture of plastic materials and articles. The list includes:

  • monomers;
  • additives (excluding colorants);
  • polymer production aids (excluding solvents); and
  • macromolecules obtained from microbial fermentation.

By way of derogation, substances not included on this list may be authorised under certain conditions.

Requirements on substances

This Regulation lays down the conditions of use for authorised substances (see Annex II) and migration limits (see Annex I). These migration limits correspond to the maximum amount of substances that materials and articles may transfer to food. They are expressed in mg of substance per kg of food (mg/kg).

All plastic materials and articles must comply with specific migration limits and overall migration limits.

The composition of each plastic layer constituting a material or article must comply with this Regulation. However, a layer which is not in direct contact with food may:

  • not comply with the restrictions and specifications of this Regulation (except for vinyl chloride monomer as provided in Annex I);
  • be manufactured with substances not included on the list of authorised substances (these substances must nevertheless not be mutagenic, carcinogenic or toxic to reproduction, or be in nanoform).

Declaration of compliance

The manufacturer shall draw up a written declaration containing the information set out in Annex IV. The information provided shall identify the materials, articles and products from intermediate stages of their manufacturing as well as the substances themselves. This declaration shall be renewed when substantial changes in the composition or production occur.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EU) No 10/2011

4.2.2011

OJ L 12, 15.1.2011

The successive amendments and corrections to Regulation (EC) No 10/2011 have been incorporated into the original text. This consolidated version  is of documentary value only.

Restriction of epoxy derivatives in food packaging

Restriction of epoxy derivatives in food packaging

Outline of the Community (European Union) legislation about Restriction of epoxy derivatives in food packaging

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Restriction of epoxy derivatives in food packaging

Document or Iniciative

Commission Regulation (EC) No 1895/2005 of 18 November 2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food.

Summary

Authorisation of BADGE

Following the opinion issued by the European Food Safety Authority (EFSA), the European Commission permits the use of the substance known as BADGE * in materials and articles * used in packaging or other articles intended to come into contact with food, including active and intelligent packaging.

The specific migration limit for this substance is:

  • 9 mg/kg in food or food simulants;
  • 9 mg/6dm2 for containers with a capacity of less than 500 ml or more than 10 litres, but also for sheet and film.

(See also “Provisional arrangements” below.)

In addition, materials and articles containing BADGE must be accompanied by a written declaration stating that they comply with the rules. This compulsory declaration will be required as of 1 January 2007.

Prohibition of BFDGE *

and NOGE *

Two other substances used in manufacturing packaging or other items in contact with food have been prohibited: BFDGE and NOGE.

NOGE and BFDGE had been prohibited since 31 December 2004, in accordance with Directive 2002/16/EC, now repealed. The current Regulation maintains this ban, applicable as of 1 January 2005. However, the Regulation permits the exhaustion of existing stocks of these products (see “Provisional arrangements” below).

Exceptions for large containers

Large containers (capacity greater than 10 000 litres) may continue to use BADGE, NOGE and BFDGE in their special surface coatings without having to comply with limits for migration (or transfer of significant levels of these substances to the products in contact). The level of migration for this type of container is negligible, according to the Regulation.

Provisional arrangements

BADGE, NOGE and BFDGE placed on the market before 1 March 2003 may continue to be marketed, provided the date of filling appears on them.

Background

Materials and articles containing BADGE, BFDGE and NOGE may transfer significant levels of these substances to foodstuffs (migration), particularly when used as additives, which may pose a risk to human health.

The use and/or presence of BADGE had been prohibited as of 31 December 2005 by Directive 2002/16/EC, but Regulation (EC) No 1895/2005, which repeals it, once again permits the use of this group of substances. After analysing the toxicological data transmitted for this group of substances, the European Food Safety Authority (EFSA) concluded that they do not raise concerns about carcinogenicity and genotoxicity in vivo.

Key terms used in the act
BADGE: – 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether and BADGE.H2O (CAS No = 076002-91-0) and BADGE.H2O (CAS No = 005581-32-8);
BFDGE: bis(hydroxyphenyl)methane bis(2,3-epoxypropyl) ethers;
NOGE: novolac glycidyl ether;
Materials and articles in contact with foodstuffs:
– materials and articles made of any type of plastics,
– materials and articles covered by surface coatings,
– adhesives.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1895/2005 01.01.2006 OJ L 302 of 19.11.2005

Related Acts


Regulation (EC) No 1935/2004

of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC [Official Journal L 338 of 13.11.2004].

Council Directive 82/711/EEC

of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs [Official Journal L 297 of 23.10.1982; corrigendum L 332 of 27.11.1982]

Materials and articles which come into contact with foodstuffs

Materials and articles which come into contact with foodstuffs

Outline of the Community (European Union) legislation about Materials and articles which come into contact with foodstuffs

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Materials and articles which come into contact with foodstuffs

Document or Iniciative

Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC [See amending acts].

Summary

This Regulation aims at guaranteeing a high level of protection of human health and the interests of consumers with regard to the placing on the Community market of materials and articles intended to come into contact with food either directly or indirectly.

Scope

This Regulation covers all materials and articles that are intended to come into contact with food: all types of packaging, bottles (plastic and glass), cutlery, and even adhesives and inks for printing labels.

The Regulation also introduces specific provisions concerning “active”
* and “intelligent”
*
packaging which extends the shelf-life of food or which reacts when food has gone off (packaging which changes colour, for example).

The Regulation does not cover:

  • materials and articles which are supplied as antiques;
  • covering or coating materials, such as materials which cover cheese rinds, prepared meat products or fruit;
  • fixed water supply equipment.

Requirements for materials and articles

Materials and articles which come into contact with food shall be produced in line with good manufacturing practice. They must under no circumstances transfer substances to the food with which they are in contact in quantities likely to:

  • endanger human health;
  • bring about an unacceptable change in the composition of the food; or
  • bring about a deterioration in the organoleptic characteristics thereof.

If “active” materials and articles change the composition or organoleptic characteristics of food, they must comply with Directive 89/107/EEC on additives and/or any national rules.

The labelling, advertising and presentation of a material or article shall not mislead consumers under any circumstances.

Specific measures for groups of materials and articles

Annex I of this Regulation identifies 17 groups of materials and articles for which specific measures may be adopted:

  • intelligent materials and articles;
  • adhesives;
  • ceramics;
  • cork;
  • rubbers;
  • glass;
  • ion-exchange resins;
  • metals and alloys;
  • paper and cardboard;
  • plastic materials;
  • printing inks;
  • regenerated cellulose;
  • silicones;
  • textiles;
  • varnishing and coatings;
  • waxes;
  • wood.

These specific measures may include:

  • the list of substances authorised for use in the manufacture of materials and articles that are intended to come into contact with food;
  • criteria of purity;
  • specific conditions of use;
  • limits on the migration of certain constituents into or on to food;
  • provisions aimed at protecting human health or ensuring compliance with requirements for materials and articles that are intended to come into contact with food;
  • basic rules for checking compliance with the provisions above;
  • rules concerning the collection of samples;
  • provisions for ensuring traceability;
  • additional provisions of labelling for active and intelligent materials and articles;
  • provisions concerning the establishment of a Community Register of authorised substances, processes, materials or articles;
  • specific procedural rules for the authorisation of a substance, process, material or article.

In the absence of specific measures, Member States may maintain or adopt national provisions.

Authorisation of substances

Applications for authorisation of a new substance for the manufacture of materials or articles intended to come into contact with food shall be made to the competent authority of the Member State where the substance is to be placed on the market. Applications shall then be sent to the European Food Safety Authority which is responsible for evaluating the toxicity of substances in order to avoid any risk to consumers.

Traceability

This Regulation also establishes the requirements to be met regarding the traceability of food contact materials from production to sale.

The labelling or documentation accompanying materials and articles placed on the market in the Community should guarantee the traceability of the said materials and articles. This facilitates control, the recall of defective products, consumer information and the attribution of responsibility.

Labelling

The nature of materials and articles intended to come into contact with food is to be described on their labelling. Materials and articles which are not clearly intended to contain or to package food must bear the words “For food contact” or the symbol given in Annex II (the symbol represents a glass and a fork).

Context

Earlier legislation on materials in contact with foodstuffs protected the health of consumers by ensuring that no material or article in contact with foodstuffs could bring about chemical reactions which would change the composition or organoleptic properties of these foodstuffs (taste, appearance, texture or even smell).

This Regulation repeals this legislation in order to allow the introduction of “active” and “intelligent” packaging. It also repeals Directive 80/590/EEC determining the symbol that may accompany materials and articles intended to come into contact with foodstuffs and incorporates the symbol in Annex II (see the above explanation on labelling).

Key terms of the Act
  • Materials and articles intended to come into contact with food: materials and articles that are intended to extend the shelf-life or to maintain or improve the condition of packaged food. They are designed to deliberately incorporate components that would release or absorb substances into or from the packaged food or the environment surrounding the food.
  • Intelligent materials and articles intended to come into contact with food: materials and articles which monitor the condition of packaged food or the environment surrounding the food.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1935/2004

3.12.2004

OJ L 338 of 13.11.2004


Amending act(s)
Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 596/2009

7.8.2009

OJ L 188 of 18.7.2009