Tag Archives: Food

Official feed and food controls

Outline of the Community (European Union) legislation about Official feed and food controls

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

Official feed and food controls

Document or Iniciative

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. [See Amending Acts].

Summary

This Regulation is designed to fill in the loopholes in the existing legislation concerning the official control of food and feed thanks to a harmonised Community approach to the design and implementation of national control systems.

The purpose of this Regulation is:

to prevent or eliminate risks which may arise, either directly or via the environment, for human beings and animals, or reduce these risks to an acceptable level;
to guarantee fair practices as regards trade in food and feed and the protection of consumers’ interests, including labelling of food and feed and any other form of information intended for consumers.

Official controls are defined as “any form of control performed by the competent authority or by the Community for the verification of compliance with feed and food law, as well as animal health and animal welfare rules”.

This Regulation does not apply to official controls for the verification of compliance with the rules on common market organisations agricultural products.

OBLIGATIONS RELATING TO OFFICIAL CONTROLS

The basic principles related to responsibilities of the Member States’ authorities are already laid down in the Regulation (EC) No 178/2002, which lays down the general principles of food law. The present regulation describes in more detail how these principles must be interpreted and implemented.

The official controls carried out by the Member States must enable them to verify and ensure compliance with national and Community rules on feed and food. To this end, official controls must in principle be carried out at any stage of production, processing and distribution of feed and food. These controls are defined as a function of the identified risks, the experience and knowledge gained from previous controls, the reliability of the controls already carried out by the business operators concerned, and a suspicion of possible non-compliance.

Competent authorities

The Member States designate the competent authorities responsible for performing the official controls. These authorities must satisfy the operational criteria ensuring their effectiveness and their impartiality. They must also have the necessary equipment and suitably qualified staff (areas specified in Annex II) and have contingency pans. Internal or external audits may be carried out to ensure that the competent authorities are achieving the objectives of the Regulation.

When some of the controls are delegated to regional or local authorities, it is necessary to ensure effective cooperation between the central authority and these authorities.

The competent authority may delegate certain control tasks to non-governmental bodies provided these bodies meet the strictly defined conditions set out in this Regulation. Hence a procedure is therefore provided to define the tasks that can (or cannot) be delegated to such bodies. The adoption of coercive measures may not be delegated. The competent authority may proceed to audit or inspect the bodies to which the tasks have been delegated.

Transparency and confidentiality

The competent authorities must ensure that relevant information they hold is made available to the public, notably when there are reasonable grounds to suspect that food or feed may present a risk for human or animal health.

The staff of the competent authorities are required not to disclose information acquired when carrying out their control duties which by its nature is covered by professional secrecy.

Sampling and analysis

The methods of sampling and analysis used within the context of official controls must be fully validated in accordance with Community legislation or with internationally accepted protocols. These analysis methods must take into account the criteria set out in Annex III and must be implemented by laboratories approved to this end in compliance with the standards laid down by the European Committee for Standardisation (CEN).

Intervention plans

Contingency plans must be prepared which set out the measures to be implemented in the event of an emergency where feed or food have been found to pose a serious risk to humans or animals either directly or through the environment. These contingency plans specify the administrative authorities to be engaged together with their powers and responsibilities.

Controls on products from Non-EU Member Countries

This regulation supplements the provisions set out in Directive 97/78/EC concerning controls applicable to feed and food of animal origin. For example, it introduces the following principles for feed and food of non-animal origin:

regular official controls by the Member States of feed and food of non-animal origin imported into the European Union (EU). These controls can take place at any point of the distribution of the goods: before release for free circulation or afterwards, e.g. at the importer’s premises, during processing or at the point of retail sale. There shall in any way be a close co-operation between the customs services and the competent authority;
at Community level, a list of at-risk feed and food must be established and updated. Such feed and food must be presented at specially designated and equipped inspection posts for the carrying out of the necessary checks. These controls must be carried out at the point of entry in the EU before the goods are released for free circulation.
the possibility of carrying out official controls on feed and food originating in Non-EU Member Countries which enter into free zones and free warehouses or is placed in transit, customs warehousing, inward processing, processing under customs control or temporary admission.

The abovementioned controls include at least a documentary control, an identity control and, where relevant, a physical control.

In the case that non-compliance with the legislation is ascertained, the products may be seized or confiscated, and shall be destroyed, submitted to a special treatment, or re-dispatched outside the Community; the operator responsible for the consignment in question shall be liable for the costs incurred.

Specific pre-export checks performed by a Non-EU Member Country may be approved provided they satisfy the requirements of the Community or requirements which are at least equivalent. If such an approval is granted, the frequency of the controls carried out by the Member States may be adapted.

Financing of official controls

Member States must ensure that adequate financial resources are made available for official controls.

Inspection fees are imposed on feed and food business operators, common principles must be observed for setting the level of such fees and the methods and data used for the calculation of the fees must be published or otherwise made available to the public.

When official controls reveal non-compliance with feed and food law, the extra costs that result from more intensive controls must be borne by the feed and food business operator concerned.

Certification

This proposal provides for a procedure making it possible to specify the cases and conditions in which official certification must be granted.

Reference laboratories

A number of Community Reference Laboratories (CRLs) have been established (Annex VII) under Community legislation in force. They may be entitled to EU financial support and are responsible for:

providing national reference laboratories with details of analytical methods;
organising comparative testing, coordinating within their area of competence the practical and scientific activities necessary for developing new analytical methods;
conducting training courses;
providing scientific and technical assistance to the Commission.

For each CRL, Member States must ensure that one or more national reference laboratories are designated. These function as the point of communication between the CRL and all the official laboratories in the Member States.

ADMINISTRATIVE MEASURES

Assistance and cooperation

When the official controls require action by more than one Member State, the competent authorities must afford each other administrative assistance. This assistance may involve active cooperation, including participation in on-the-spot controls carried out by experts from one Member State in another Member State.

Each Member State must designate a single liaison body whose role is to assist and coordinate the communication, transmission and reception of requests for assistance. Where it receives a reasoned request (existence of a serious risk), the liaison body contacts the authorities concerned and ensures that the requesting authority is provided with all necessary information and documents enabling the latter to verify compliance with the law.

When the competent authority of a Member State receives information from a Non-EU Member Country, that authority must pass that information on to the competent authorities of the Member State which might be interested in it.

Administrative assistance applies to the exchange of all information, except that which cannot be released because of it being the subject of legal proceedings or because it may adversely affect the commercial interests of natural or legal persons.

National Control Plans

The Member States must prepare an integrated multi-annual national control plan. This plan, whose implementation must begin by 1 January 2007 at the latest, sets out the national control system and activities in a global and comprehensive way. The plan will have to be developed along the lines that are contained in guidelines to be established by the Commission in consultation with the Member States.

One year after starting the implementation of the national control plans, and subsequently every year, the Member States must submit to the Commission a report indicating an update of their initial control plan. The Commission must establish a general report on the overall operation of the official control systems on the basis of the national reports and the results of the audits which it has carried out. It passes this report on to the European Parliament and the Council and publishes it.

Community controls in the Member States

Until now, Community controls in the Member States were organised in function of the mandates the Commission has in the different sectoral Directives.. The creation of a single legal basis with this Regulation and the establishment of control plans will allow the EU control services to perform a general audit of the Member States’ control systems globally. If needed, these inspections and national audits performed by the Commission’s Food and Veterinary Office (FVO) can be supplemented by more specific audits and inspections for a particular sector or problem. For each control carried out, the Commission establishes a report on its findings and, where appropriate, this report contains recommendations which must be followed up by the Member States.

This Regulation also provides that Commission experts may carry out controls in Non-EU Member Countries and require that these countries have control plans comparable with those of the Member States in respect of the products they export to the European Union. These plans must be technically and economically feasible taking account of specific situation of the Non-EU Member Country as well as the nature of the products exported to the Community.

Non-EU Member Country controls in Member States

Non-EU Member Countries which wish to export goods to the EU must provide the Commission with information on the organisation and general management of their health surveillance systems. If this information is not satisfactory, provisional measures may be taken by the Commission after consulting the country concerned.

The Commission must take account of the lists drawn up pursuant to Regulation (EC) No 854/2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption. For other types of products the Commission may eventually draw up comparable lists or adopt other measures (certificates, special import conditions, etc.).

Training of control officials

There must be a Community framework for training control staff in the Member States in order to ensure a uniform level of the decisions taken by such staff Hence the Commission may organise training courses relating to legislation, control measures and techniques, the manufacture, processing and marketing of food and feed.

Non-EU Member Country controls in the Member States

The authorities of Non-EU Member Countries may organise controls in the Member States, accompanied where appropriate by representatives of the FVO, who can assist Member States by providing information and data that are available at Community level and that may be useful in the context of the Non-EU Member Country control carried out.

National enforcement measures

Where non-compliance is ascertained during official controls, the competent authority concerned must take appropriate measures taking into account the nature of the non-compliance and that operator’s past record with regard to non-compliance. This may involve administrative measures (withdrawal from the market or destruction of a product, closure of a business or suspension of an establishment’s approved status, etc.) or penalties. These penalties must be effective, proportionate and dissuasive.

Community enforcement measures

This regulation adds a new dimension to the safeguard measures provided for in Regulation (EC) No 178/2002, hence allowing the Commission to take measures when there is proof that a Member State’s control system is inadequate. These may include the suspension of the placing on the market of certain feed or foodstuffs or the laying down of special conditions for certain feed or foodstuffs. These measures are taken if Community controls have shown non-compliance with Community legislation and the Member State concerned has failed to correct the situation upon request and within the time limit set by the Commission.

BACKGROUND

In January 2000 the Commission presented a complete overhaul of the legislation concerning food hygiene and veterinary issues. The overhaul contained four proposals, on the following subjects:

food hygiene;
the rules related to hygiene for food of animal origin;
official controls on products of animal origin intended for human consumption;
animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption ;
official controls of food and feed, which are the subject of this information sheet.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 882/2004	20.05.2004	–	OJ L 165 of 30.04.2004

Regulation (EC) No 1162/2009 [Official Journal L 314 of 1.12.2009].
Regulation (EC) No 1162/2009 grants additional time to laboratories located in slaughterhouses carrying out official testing for Trichinella to obtain full accreditation. The granting of the exception is subject to compliance with certain conditions. In particular, the laboratories in question must demonstrate that they have taken steps in view of their accreditation and offer satisfactory guarantees regarding the quality of the analyses they carry out.

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 1029/2008	10.11.2008	–	OJ L 278 of 21.10.2008
Regulation (EC) No 596/2009	7.8.2009	–	OJ L 188 of 18.7.2009

Amending act(s)

Entry into force

Deadline for transposition in the Member States

Official Journal

Regulation (EC) No 1029/2008

10.11.2008

–

OJ L 278 of 21.10.2008

Regulation (EC) No

596/2009

7.8.2009

–

OJ L 188 of 18.7.2009

The successive amendments and corrections to Regulation (EC) No 882/2004 have been incorporated into the original text. This consolidated versionis of documentary value only.

Related Acts

Commission Decision 2009/821/EC of 28 September 2009 drawing up a list of approved border inspection posts, laying down certain rules on the inspections carried out by Commission veterinary experts and laying down the veterinary units in Traces [Official Journal L 296 of 12.11.2009].
See consolidated version

Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC [Official Journal L 194 of 25.7.2009].
See consolidated version

Accession of the European Community to the Codex Alimentarius Commission

Outline of the Community (European Union) legislation about Accession of the European Community to the Codex Alimentarius Commission

Topics

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

Food safety > International dimension and enlargement

Accession of the European Community to the Codex Alimentarius Commission

Document or Iniciative

Council Decision 2003/822/EC of 17 November 2003 on the accession of the European Community to the Codex Alimentarius Commission [Official Journal L 309, 26.11.2003].

Summary

Context

The Codex Alimentarius (or food code) is a joint programme of the FAO (the UN’s Food and Agriculture Organisation) and the WHO (World Health Organisation), which lays down food health standards that serve as a reference for international trade in foodstuffs.

Since 1994 and the entry into force of the WTO Agreements on Sanitary and Phytosanitary Measures (SPS Agreement) and on Technical Barriers to Trade (TBT Agreement), the legal relevance of the Codex standards has increased. Indeed these two Agreements make reference to those standards, meaning that the latter are used as the basis for the evaluation of national measures and regulations.

At present, all Member States of the European Union (EU), and, since the end of 2003, the European Community as such are members of the Codex Alimentarius Commission, which is the body in charge of updating the Codex.

This Decision concerns the application of the European Community to accede to the CAC, achieved in 2003. It is accompanied by a declaration on the exercise of competence between the European Community and its Member States and by the text of the Arrangement between the Council and the Commission regarding preparation for meetings and statements and the exercise of voting rights within the CAC.

Background to the accession negotiations

Since Article 2 of the CAC’s statutes authorises any FAO member to become a full member, the European Community started negotiations to that end in the mid-1990s.
In January 1994, the Council authorised the Commission to enter into negotiations, on behalf of the Community, with the CAC Secretariat with a view to defining the conditions and procedures for the Community’s accession.
Discussions between the Commission and Council had since then been blocked by Member State concerns about internal coordination and the division of responsibilities.
As a result of the White Paper on Food Safety, which reaffirmed the benefits of CAC membership, negotiations with the CAC Secretariat on accession conditions resumed during 2001.

In June 2003, the CAC amended its Rules of Procedure allowing regional economic integration organisations to become members, thus opening the way to the accession of the European Community alongside its Member States.

The Codex Alimentarius Commission: aims and mode of operation

The CAC was created by the WHO and FAO in 1963 to implement their Joint Food Standards Programme aimed at protecting the health of consumers, ensuring fair trade practices in the food trade and promoting coordination of all food standards work undertaken by governmental and international organisations.

Its main aim, then, is to define international standards, codes of practice and other guidelines and recommendations concerning agricultural and fishery products, foodstuffs, food additives, food contaminants, animal feed and the residues of veterinary products and pesticides as well as labelling, inspection and certification systems, analysis and sampling methods, ethics and good farming practice codes and food hygiene practices.
These standards are then published in one of the Codex’s 13 volumes:

general requirements and general requirements for food hygiene;
general texts on pesticide residues in food and maximum limits for same;
residues of veterinary drugs in foods;
foods for special dietary uses, including foods for infants and children;
processed and quick-frozen fruits and vegetables, fresh fruits and vegetables;
fruit juices;
cereals, pulses and derived products and vegetable proteins;
fats and oils and related products;
fish and fishery products;
meat and meat products;
soups and broths;
sugars, cocoa products and chocolate and miscellaneous products;
milk and milk products;
methods of analysing and sampling.

The CAC’S work also encourages food traders to voluntarily adopt ethical practices. To that end, the CAC has published a Code of ethics for international trade in food, which now forms part of the Codex.

The CAC currently comprises 171 countries and holds meetings every year. It is helped in developing its standards by subsidiary bodies, which include committees dealing with horizontal matters (for example, general principles, labelling, food hygiene, food additives and contaminants, etc.), committees dealing with vertical matters, i.e. specialising in one type of product (for example, milk and milk products, fish and fishery products, etc.), “task forces” dedicated to a particular task of limited duration and regional coordinating committees. In addition, the experts’ meetings organised and supported by the FAO and the WHO provide the essential scientific basis (risk assessment) for the CAC’S work and the publications resulting from their activities act as international references. There are three of these groups of experts, the Joint FAO/WHO Meeting on Pesticide Residues (JMPR), the Joint FAO/WHO Meeting on Microbiological Risk Assessment (JEMRA) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

Activities of the European Community and its Member States within the CAC

The CAC’s Rules of Procedure now allow a member organisation to share its voting rights with its Member States in accordance with their respective competences. When the member organisation is entitled to vote, the number of votes it may cast is equal to the number of Member States present when the vote is taken, hence the importance of Member States being present. This rule is the result of a compromise reached with developing countries, which, in the interests of fairness, could not accept the vote of a country not present being counted.

Competence is assigned as follows:

the European Community has exclusive competence for matters on which the rules have already been harmonised, either fully or to a large extent, at Community level. In such cases, the Commission speaks and votes in the name of the Community, although Member States have the right to speak in favour of the Community position and to react to contributions from other countries;
the Member States have exclusive competence for all organisational matters (for example, legal or budgetary questions) and for procedural matters (for example, the election of chairpersons, the adoption of agendas and the approval of minutes);
competence is shared where rules have been only partially harmonised: the vote is exercised either by the Member States or the Community, depending on the degree of harmonisation achieved. In such cases, the Presidency and the Commission put forward the common position. Member States may also speak in order to support and/or develop the Community position and to react to contributions.

Before each meeting of the CAC or of one of its subsidiary bodies, an annotated agenda, indicating who, within the organisation or its Member States, is competent for each item and is to exercise the right to vote, is drawn up and given to all participants.

In addition, the Member States and the Commission have the right to participate in the Codex working groups and drafting committees and express their opinions there. Member State and Commission representatives endeavour to reach a common position and defend this during discussions in the working groups and drafting committees,

The HACCP principles (Hazard Analysis and Critical Control Point) and the Codex Alimentarius

The measures taken by the EU with regard to food safety and food frequently invoke the Codex as justification. This is true particularly of the HACCP principles, which are the basis of European legislation relating to food hygiene and official controls on products of animal origin intended for human consumption.

These principles, developed by the CAC since the early 1990s, prescribe a number of stages to be followed throughout the production cycle in order to allow, on the basis of a risk analysis, the identification of critical points that need to be monitored to ensure food safety:

identification of all risks to be avoided, eliminated or reduced to acceptable levels;
identification of the critical or limit points where surveillance becomes essential;
establishment and application of effective procedures for monitoring critical points;
adoption of corrective measures when monitoring reveals a critical point is being overstepped.

Relationship between the WTO and the Codex Alimentarius

When the WTO was set up in April 1994, two specific agreements were concluded in Marrakech to restrict barriers to trade justified on the basis of protectionist technical regulations:

the Agreement on Sanitary and Phytosanitary Measures (SPS Agreement);
the Agreement on Technical Barriers to Trade (TBT Agreement).

The SPS Agreement lays down the conditions on which a State can adopt and implement health measures (animal health, food safety) or phytosanitary measures (protection of plants) that have a direct or indirect impact on international trade. This Agreement makes explicit reference to the standards defined by the Codex to impose limits on the actions of the signatory States.
Thus the preamble to this Agreement declares itself in favour of furthering “the use of harmonized sanitary and phytosanitary measures between Members, on the basis of international standards, guidelines and recommendations developed by the relevant international organisations, including the Codex Alimentarius Commission”.

The TBT Agreement aims to guarantee that technical regulations and standards do not create unnecessary obstacles to international trade. It too makes extensive reference to international standards, though without explicitly citing the Codex, in the context of the harmonisation that it advocates.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Decision 2003/822/EC	17.11.2003	–	OJ L 309 of 26.11.2003

Active and intelligent materials and articles

Outline of the Community (European Union) legislation about Active and intelligent 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

Active and intelligent materials and articles

Document or Iniciative

Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food.

Summary

This Regulation establishes specific requirements for the marketing of active * and intelligent * materials and articles intended to come into contact with food. It supplements the general principles defined in Regulation (EC) No 1935/2004 and describes the procedure for the authorisation of substances at Community level.

Scope

This Regulation shall apply to active or intelligent materials and articles which are placed on the Community market.

Requirements for active and intelligent materials and articles

Active and intelligent materials and articles:

must be suitable and effective for the intended purpose of use;
must not release to food any components * in sufficient quantity as to endanger human health or to bring about an unacceptable change in the composition or organoleptic characteristics of food;
must not mislead consumers through their labelling, presentation or advertising material.

These specific requirements are without prejudice to Community or national provisions applicable to materials and articles to which active or intelligent components are added or into which they are incorporated.

Composition

Only substances which are included in the Community list of authorised substances may be used in components of active and intelligent materials and articles.

However, the following substances may be used in components of active and intelligent materials and articles without being included in the Community list:

released active substances, added or incorporated by techniques such as grafting or immobilisation which are used in full compliance with the relevant Community and national provisions (for example, legislation on food additives and food enzymes);
substances used in the components which are not in direct contact with food or the environment surrounding the food; and if they are not “mutagenic”, “carcinogenic”, or “toxic to reproduction” or substances produced deliberately in a particle size that exhibits chemical and physical properties that significantly differ from those at a larger scale.

Applications for authorisation of substances constituting the components of active and intelligent materials and articles

Applications for authorisation of substances constituting the components of active and intelligent materials and articles are to be made to the competent authorities of a Member State accompanied by a technical dossier containing the information described in the guide to safety assessment prepared by the European Food Safety Authority.

The Member State sends the application to the Authority which is responsible for assessing whether the substance meets the above conditions.

Community list of authorised substances

In order to be included in the Community list, substances constituting the components of active and intelligent materials and articles must meet the requirements that apply to the said products (see above).

The Commission shall adopt the Community list after the Authority has delivered its opinion on all substances for which a valid application for market authorisation has been submitted.

The Community list shall specify:

the identity of the substance(s);
the function of the substance(s);
the reference number;
if necessary, the conditions of use of the substance(s) or component.

Labelling

Active and intelligent materials and articles:

in contact with food are to be labelled appropriately to allow the consumer to identify the non-edible parts. In this case the words “DO NOT EAT” must be added to the label as well as (if possible) the symbol reproduced in Annex I;
labelled so that it is clear that they are active and/or intelligent.

Released active substances are considered as ingredients and are to be labelled pursuant to the general rules for the labelling of foodstuffs.

Application

The provisions relating to the composition of active and intelligent materials and articles apply from the date at which the Community list of substances that may be used in the composition of the said materials and articles enters into force.

The provisions on labelling apply from 19 December 2009.

Key terms of the Act
Active materials and articles: materials and articles 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 substances into or onto the packaged food or the environment surrounding the food. Intelligent materials and articles: materials and articles which monitor the condition of packaged food or the environment surrounding the food. A component: an individual substance or a combination of individual substances which cause the active and/or intelligent function of a material or article, including the products of an in situ reaction of those substances; it does not include the passive parts, such as the material they are added to or incorporated into.

Key terms of the Act

Active materials and articles: materials and articles 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 substances into or onto the packaged food or the environment surrounding the food.
Intelligent materials and articles: materials and articles which monitor the condition of packaged food or the environment surrounding the food.
A component: an individual substance or a combination of individual substances which cause the active and/or intelligent function of a material or article, including the products of an in situ reaction of those substances; it does not include the passive parts, such as the material they are added to or incorporated into.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 450/2009	19.6.2009	–	OJ L 135 of 30.5.2009