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Food hygiene

Food hygiene

Outline of the Community (European Union) legislation about Food hygiene

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

Food hygiene

Document or Iniciative

Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs [See amending act(s)].

Summary

This Regulation replaces Directive 93/43/EEC on the hygiene of foodstuffs *, with a view to establishing a comprehensive and integrated policy covering all food from the farm to the point of sale to the consumer.

Scope

This Regulation seeks to ensure the hygiene of foodstuffs at all stages of the production process, from primary production * up to and including sale to the final consumer. It does not cover issues relating to nutrition or to the composition or quality of foodstuffs.

This Regulation applies to food businesses but not to the primary production of food for private domestic use or the domestic preparation of foodstuffs for private consumption.

General and specific provisions

All food business operators shall ensure that all stages for which they are responsible, from primary production up to and including the offering for sale or supply of foodstuffs to the final consumer, are carried out in a hygienic way in accordance with this Regulation.

Food business operators carrying out primary production and certain associated activities shall comply with the general hygiene provisions of part A of Annex I. Derogations may be granted for small businesses, provided that they do not compromise achievement of the Regulation’s objectives.

These associated activities are:

  • the transport, handling and storage of primary products at the place of production, where their nature has not been substantially altered;
  • the transport of live animals, where this is necessary;
  • transport, from the place of production to an establishment, of products of plant origin, fishery products and wild game, where their nature has not been substantially altered.

In addition, food business operators carrying out activities other than primary production shall comply with the general hygiene provisions of Annex II.
This Annex sets out the hygiene requirements for:

  • food premises, including outside areas and sites;
  • transport conditions;
  • equipment;
  • food waste;
  • water supply;
  • personal hygiene of persons in contact with food;
  • food;
  • wrapping and packaging;
  • heat treatment, which may be used to process certain foodstuffs;
  • training of food workers.

Member States may adapt the requirements laid down in Annex II to accommodate the needs of food businesses situated in regions suffering from special geographical constraints or affected by supply difficulties which are serving the local market, or to take account of traditional methods of production and the size of farms. The objectives of food safety * shall not however be compromised.

In addition, all food business operators shall comply with the provisions of Regulation (EC) No 853/2004 on specific hygiene rules for food of animal origin and, where appropriate, certain specific rules concerning microbiological criteria for foodstuffs, temperature control and compliance with the cold chain, sampling and analysis.

The HACCP system

Food business operators (other than at the level of primary production) shall apply the principles of the system of hazard analysis and critical control points (HACCP) introduced by the Codex Alimentarius (code of international food standards drawn up by the United Nations Food and Agriculture Organisation).

These principles prescribe a certain number of requirements to be met throughout the cycle of production, processing and distribution in order to permit, via hazard analysis, identification of the critical points which need to be kept under control in order to guarantee food safety:

  • identify any hazards that must be prevented, eliminated or reduced to acceptable levels;
  • identify the critical control points at the step or steps at which control is essential;
  • establish critical limits beyond which intervention is necessary;
  • establish and implement effective monitoring procedures at critical control points;
  • establish corrective actions when monitoring indicates that a critical control point is not under control;
  • implement own-check procedures to verify whether the measures adopted are working effectively;
  • keep records to demonstrate the effective application of these measures and to facilitate official controls by the competent authority.

Guides to good practice and guides to the application of HACCP

Member States shall encourage the development of national guides to good practice by food business operators, which shall include guidance on compliance with the general rules of hygiene and the HACCP principles. Member States shall assess such national guides to ensure that their contents are practicable, that they have been developed having regard to the general principles of food hygiene of the Codex Alimentarius and that all interested parties have been consulted. Those national guides deemed to comply with these requirements shall be forwarded to the Commission.

Where a Member State or the Commission considers that there is a need for uniform Community guides, the Commission shall consider the case for such guides. The Standing Committees set up to assist the Commission shall ensure that the contents of these guides are practicable, that they have been developed having regard to the general principles of food hygiene of the Codex Alimentarius and of national guides, and that all interested parties have been consulted.

Food business operators may refer to national guides or Community guides equally.

Registration or approval of food businesses

Food businesses operators shall cooperate with the competent authorities and in particular ensure that all establishments under their control are registered with the appropriate authority and keep this authority informed of any changes (e.g. closure of the establishment).

Where required by national or Community legislation, businesses in the food sector must be approved by the competent authority and shall not operate without such approval.

Traceability and withdrawal of food products

In accordance with Regulation (EC) No 178/2002, food business operators shall set up traceability systems and procedures for ingredients, foodstuffs and, where appropriate, animals used for food production.

Similarly, where a food business operator identifies that a foodstuff presents a serious risk to health it shall immediately withdraw that foodstuff from the market and inform users and the competent authority.

Official controls

The application of HACCP principles by food business operators shall not replace the official controls carried out by the competent authority. Operators are required to collaborate with the competent authorities in accordance with Community legislation or, where none exists, national legislation.

External dimension

Foodstuffs imported into the Community shall comply with the Community hygiene standards or with equivalent standards.

Foodstuffs of animal origin exported out of the Community shall at least comply with the requirements that would apply if they were marketed within the Community, as well as to any requirements that may be imposed by the importing country.

Report to the Council and Parliament

The Commission shall submit a report to the European Parliament and the Council, where appropriate with any relevant proposals, within five years of this Regulation entering into force, reviewing the experience gained from implementing this Regulation and determining whether it is appropriate to apply HACCP principles to food business operators carrying out primary production activities and the associated activities described above.

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 853/2004 laying down specific hygiene rules for food of animal origin in order to guarantee a high level of food safety and public health;
  • 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 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;
  • 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.
Key terms of the Act
  • Food hygiene: the measures and conditions necessary to control hazards and ensure fitness for human consumption of a foodstuff;
  • Primary production: the production, rearing or growing of primary products up to and including harvesting, hunting, fishing, milking and all stages of animal production prior to slaughter;
  • Food safety: the assurance that food will not cause adverse health effects to the final consumer when it is prepared and eaten.

References

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

Regulation (EC) No 852/2004

20.5.2004

OJ L 139 of 30.04.2004

Amending act 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

The successive amendments and corrections to Regulation (EC) No 852/2004 have been incorporated into the original text. This consolidated versionis of documentary value only.

Related Acts

Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs [Official Journal L 338 of 22.12.2005].
See consolidated version

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) No 854/2004 [Official Journal L 338 of 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.

Standing Committee on the Food Chain and Animal Health

Standing Committee on the Food Chain and Animal Health

Outline of the Community (European Union) legislation about Standing Committee on the Food Chain and Animal Health

Topics

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

Food safety > Food safety: general provisions

Standing Committee on the Food Chain and Animal Health

Document or Iniciative

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [See amending acts].

Summary

In order to improve the procedures relating to food safety, this Regulation establishes the Standing Committee on the Food Chain and Animal Health, hereinafter referred to as the “Committee”. It replaces the following existing committees: the Standing Committee on Foodstuffs, the Standing Committee on Animal Nutrition and the Standing Veterinary Committee. It also takes over certain tasks of the Standing Committee on Plant Health (see the heading “Background”).

Organisation

The Committee is made up of representatives of the Member States and is chaired by a representative of the Commission.

The Committee is divided into eight sections in order to cover all subjects concerned. These sections are as follows:

  • General Food Law;
  • Biological Safety of the Food Chain;
  • Toxicological Safety of the Food Chain;
  • Controls and Import Conditions;
  • Animal Nutrition;
  • Genetically Modified Food and Feed and Environmental Risk;
  • Animal Health and Animal Welfare;
  • Phytopharmaceuticals.

Tasks

The Committee is a regulatory committee. The Commission may adopt the implementing measures only if they obtain a favourable opinion from the committee, given by a qualified majority of the Member States. Failing that, the proposed measure is referred to the Council, which takes a decision by a qualified majority. However, if the Council fails to reach a decision, the Commission adopts the implementing measure unless the Council opposes it by a qualified majority.

Article 53 of this Regulation provides for an emergency procedure to allow the Committee to intervene by taking certain measures. For example, in emergencies the Commission may provisionally adopt measures after consulting the Member States concerned and informing the other Member States. As soon as possible, and at most within ten working days, the measures taken are confirmed, amended, revoked or extended in accordance with the regulatory procedure explained above, and the reasons for the Commission’s decision are made public without delay.

The Committee may also examine any issue falling under Community provisions, either at the initiative of the Chairman or at the written request of one of its members.

The Committee’s mandate covers the entire food supply chain, ranging from animal health issues on the farm to the product that arrives on the consumer’s table, thus significantly enhancing its ability to target risks to health wherever they arise in the production of our food.

The food crises of recent years have shown the need to improve food safety procedures. It is for this reason that this Regulation was adopted, so as to ensure a high level of protection of human health and consumers’ interests, whilst ensuring the effective functioning of the internal market by laying down the general principles of food law at Community and national levels, by establishing the European Food Safety Authority and by laying down procedures in matters of food safety.

Background

The Standing Committee on the Food Chain and Animal Health takes over the competence of the Standing Committee on Plant Health in relation to:

  • plant protection products (Directive 91/414/EEC);
  • the fixing of maximum levels for pesticide residues in and on fruit and vegetables (Directive 76/895/EEC), cereals (Directive 86/362/EEC), foodstuffs of animal origin (Directive 86/363/EEC), certain products of plant origin, including fruit and vegetables (Directive 90/642/EEC).

For further information please consult the website on the Standing Committee on the Food Chain and Animal Health.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 178/2002 [adoption: codecision COD/2000/0286] 21.02.2002
01.01 2005 (Articles 11, 12, 14 to 20)
Date of appointment of the Scientific Committee and the Scientific Panels (Articles 29, 56, 57, 60 and 62 paragraph 1)
OJ L 31 of 01.02.2002
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1642/2003 01.10.2003 OJ L 245 of 29.09.2003
Regulation (EC) No 575/2006 28.4.2006 OJ L 100 of 8.4.2006

Related Acts

Commission Decision 2004/613/EC of 6 August 2004 concerning the creation of an advisory group on the food chain and animal and plant health [Official Journal L 275, 25.08.2004].
This decision reorganises the existing advisory committees. The group’s responsibilities lie in the areas of food and feed safety, food and feed labelling and presentation, human nutrition, and animal health and welfare.
The maximum number of members is 45, representing European-level bodies involved in the protection of interests in the above fields.
The group meets twice a year at the premises of the Commission and whenever the Commission considers a meeting necessary.

Improving communication on agricultural product quality

Improving communication on agricultural product quality

Outline of the Community (European Union) legislation about Improving communication on agricultural product quality

Topics

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

Food safety > Food safety: general provisions

Improving communication on agricultural product quality

Document or Iniciative

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on agricultural product quality policy [COM(2009) 234 final – Not published in the Official Journal].

Summary

In this Communication, the Commission defines strategic orientations to improve, in the medium term, communication between farmers, buyers and consumers as regards agricultural product quality, to harmonise European Union (EU) rules on the quality of these products and to improve and simplify existing schemes and labels.

Marketing standards

Marketing standards guarantee fair competition and avoid the consumer being misled as to the characteristics of products. There are four types of information contained in current marketing standards:

  • a basic definition of the product identity (for example the definition of ‘butter’, ‘fruit juice’, etc.);
  • product classification (for example the minimum fat content of ‘semi-skimmed milk’ or ‘large’, ‘medium’ and ‘small’ classes of eggs, etc.);
  • reserved terms bestowing added value upon the product (for example what constitutes ‘first cold pressed’ olive oil or ‘traditional method’ sparkling wine, etc.);
  • labelling requirements concerning the origin or place of farming.

In the future, the Commission plans to:

  • establish a general basic standard. This would cover those matters where a voluntary approach might distort the internal market or where compulsory labelling is necessary to provide consumers with basic information about products;
  • extend labelling systems identifying the place of farming to products other than those which are covered at this time;
  • examine the feasibility of laying down optional reserved terms for ‘product of mountain farming’ and ‘traditional product’. The term ‘traditional product’ could replace the current system of ‘traditional specialities guaranteed’ which has not reached its full potential; and
  • contribute to developing international standards.

Geographical indications

Geographical indication schemes encourage high quality farming, safeguard protected names from unauthorised use and imitation, and help consumers by providing them with information about products’ specific attributes. At this time, there are three schemes (for wines, for spirit drinks, and for agricultural products and foodstuffs) and two instruments: the PDO (protected designation of origin) and the PGI (protected geographical indication).

After the consultation, the Commission plans to:

  • create a single register bringing together the three existing systems (wines, spirits, and agricultural products and foodstuffs), while preserving the specificities of each system; and
  • enhance the protection of geographical indications at international level.

Organic farming

Community legislation on organic farming was amended in 2007 as part of the 2004 action plan for organic farming.

In order to foster trade in organic products, the Commission:

  • has created a logo that will be mandatory for all organic products from 2010;
  • will work with third countries towards recognition for organic farming standards;
  • will contribute to improving the directives of the
    Codex Alimentarius
    on organic farming.

Certification schemes

National or private food quality certification schemes provide a guarantee that agricultural products comply with mandatory farming standards and meet requirements concerning the protection of the environment, animal welfare, etc., defined in the scheme’s specifications. However, they may confuse consumers and engender administrative costs and costs for farmers.

The Commission will establish, in consultation with the Advisory Group on Quality, good practice guidelines for private certification schemes in order to limit these drawbacks.

Context

This Communication is based on the consultation relating to the Green Paper on agricultural product quality published in October 2008, and on the High Level Conference organised on the same theme by the Czech presidency in March 2009.

The strategic orientations set out in this Communication offer a logical framework for the future policy on agricultural product quality. Comments from the other institutions but also from stakeholders will help to further refine and clarify these suggestions.

Food and feed safety

Food and feed safety

Outline of the Community (European Union) legislation about Food and feed safety

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

Food and feed safety

Document or Iniciative

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [See amending acts].

Summary

This Regulation ensures the quality of foodstuffs intended for human consumption and animal feed. It guarantees the free circulation of safe and secure food and feed in the internal market.

In addition, the European Union’s (EU) food legislation protects consumers against fraudulent or deceptive commercial practices. This legislation also aims to protect the health and wellbeing of animals, plant health and the environment.

Safety standards

No food stuff dangerous to health and/or unfit for consumption may be placed on the market. To determine whether a foodstuff is dangerous, the following are considered:

  • the normal conditions of use;
  • the information provided to the consumer;
  • the probable immediate or delayed effect on health;
  • the cumulative toxic effects;
  • the specific sensitivity of certain consumers.

Where any food which is unsafe is part of a batch, lot or consignment, it is assumed that the whole batch, lot or consignment is unsafe.

In addition, animal feed deemed to be unsafe cannot be placed on the market or fed to any food-producing animals.

Responsibilities of operators

Operators * must apply the food legislation at all stages of the food chain, from the production, processing, transport and distribution stages through to the supply of food.

In addition, operators are responsible for ensuring the traceability of products at all stages of the production, processing and distribution, including with regard to substances incorporated into the foodstuffs.

If an operator considers that a food or feed is harmful to human or animal health, they immediately initiate the procedures to withdraw the product from the market and inform the competent authorities. Where the product may have reached the consumer, the operator informs the consumers and recalls the products already supplied.

Food risk analysis

The health risk analysis is carried out in several phases: assessment, management and communication to the public. This process is carried out in an independent, objective and transparent manner. It is based on the available scientific evidence.

Where the assessment identifies the presence of a risk, the Member States and the Commission may apply the precautionary principle and adopt provisional and proportionate measures.

International market

The legislation applies to foodstuffs exported or re-exported in the EU before being placed on the market of a third country, except if the importing country decides otherwise.

The EU contributes to the development of international technical standards for food and feed, as well as for animal health and plant protection.

European food safety authority (EFSA)

A European Food Safety Authority provides scientific advice and scientific and technical support in all areas impacting on food safety. It constitutes an independent source of information on all matters in this field and ensures that the general public is kept informed.

Participation in EFSA is open to EU Member States and to other countries applying EU food safety law.

EFSA is also responsible for:

  • coordinating risk assessments and identifying emerging risks;
  • providing scientific and technical advice to the Commission, including in connection with crisis management;
  • collecting and publishing scientific and technical data in areas relating to food safety;
  • stablishing European networks of organisations operating in the field of food safety.

Rapid alert system

The rapid alert system (RAPEX) involves the Member States, the Commission and EFSA. It enables information exchange concerning:

  • measures aimed at restricting the placing in circulation or withdrawal of food or feed from the market;
  • actions taken with professional operators for controlling the use of food or feed;
  • the rejection of a batch or consignment of food or feed by an EU border post.

In the case of a food-related risk, the information disseminated within the rapid alert network must be made available to the general public.

Emergencies

Where food or feed, including those imported from a third country presents a serious and uncontainable risk to human health, animal health or the environment, the Commission puts in place protective measures and:

  • suspends the placing on the market or use of products originating from the EU;
  • suspends imports of products originating from third countries.

However, if the Commission does not act after having been informed of the existence of a risk, the Member State concerned may take protective measures. Within a period of 10 working days, the Commission must refer the matter to the Standing Committee on the Food Chain and Animal Health with a view to extending, amending or revoking the national measures.

Crisis-management plan

In the case of situations entailing direct or indirect risks to human health not provided for by the Regulation, the Commission, EFSA and the Member States may establish a general crisis-management plan.

Similarly, in the case of a serious risk, which cannot be dealt with under the existing provisions, the Commission must immediately set up a crisis unit, in which the Authority participates by providing scientific and technical support. The crisis unit is responsible for collecting and evaluating all relevant information and identifying the options available for preventing, eliminating or reducing the risk to human health.

Context

Decisions 68/361/EEC, 69/414/EEC and 70/372/EEC are repealed.

Key terms of the Act
  • Operator: the natural or legal person responsible for ensuring that the requirements of food law are met within the food business under their control.

References

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

Regulation (EC) No 178/2002

21.2.2002

1.1.2005

OJ L 031, 1. 2. 2002

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

Regulation (EC) No 1642/2003

1.10.2003

OJ L 245, 29.9.2003

Regulation (EC) No 575/2006

28.4.2006

OJ L 100, 8.4.2006

Regulation (EC) No 202/2008

25.3.2008

OJ L 60, 5.3.2008

Regulation (EC) No 596/2009

7.8.2009

OJ L 188, 18.7.2009

The successive amendments and corrections to Regulation (EC) No 178/2002 have been incorporated into the original text. This consolidated versionis of documentary value only.

Related Acts

Commission Regulation (EC) No 2230/2004 of 23 December 2004 laying down detailed rules for the implementation of European Parliament and Council Regulation (EC) No 178/2002 with regard to the network of organisations operating in the fields within the European Food Safety Authority’s mission [Official Journal L 379 of 24.12.2004].

Commission Decision 2004/478/EC of 29 April 2004 concerning the adoption of a general plan for food/feed crisis management [Official Journal L 160 of 30.4.2004].


Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption [Official Journal L 139 of 30.4.2004].

Maximum levels for certain contaminants

Maximum levels for certain contaminants

Outline of the Community (European Union) legislation about Maximum levels for certain contaminants

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

Maximum levels for certain contaminants

Document or Iniciative

Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs [See amending act(s)].

Summary

This Regulation lays down the maximum quantities for certain contaminants: nitrates, mycotoxins * (aflatoxins, ochratoxin A, patulin and Fusarium toxins), heavy metals (lead, cadmium, mercury), monochloro-propane-1, 2- diol (3-MCPD), dioxins and dioxin-type PCBs, polycyclic aromatic hydrocarbons (PAH) and inorganic tin.

Food with levels of contaminants higher than those specified in the Annex to the Regulation may not be placed on the market.

These maximum limits cover the edible part of food and also apply to compound or processed, dried or diluted foods, whereby a concentration or dilution factor may be applied or by taking into account the relative proportions of the ingredients in the compound product.

The Regulation also lays down the lowest maximum levels for contaminants which are reasonably achievable with good manufacturing practices or good agricultural practices (ALARA, As Low As Reasonably Achievable).

CONTAMINANTS

Nitrates

They are mainly present in vegetables (spinach, lettuce).

Some Member States are temporarily authorised to place on their national markets spinach and lettuce with levels of nitrates higher than those laid down in the Annex to the Regulation as long as these quantities remain acceptable in terms of public health. This transitional period is intended to allow the Member States affected to take the necessary steps to be able to comply with Community standards as quickly as possible.

The maximum levels of nitrates in vegetables are laid down according to the season.

The acceptable daily intake (ADI) laid down by the Scientific Committee on Food (SCF) is 3.65 mg/kg body weight.

Aflatoxins

These are genotoxic carcinogenic substances which develop at high temperatures and levels of humidity.

Sorting methods or other physical treatments enable the level of aflatoxins to be reduced for certain products such as groundnuts, nuts, dried fruit, maize and rice.

This Regulation permits higher levels of aflatoxins in these products if they are not intended for direct human consumption or use as an ingredient in food.

Ochratoxin A (OTA)

Ochratoxin A (OTA) is a mycotoxin produced by several fungi (penicillium and aspergillus species) with carcinogenic, nephrotoxic, teratogenic, immunotoxic and possibly neurotoxic properties. It has also been associated with nephropathy in humans.

It is naturally present in many crop products throughout the world, such as cereals, coffee beans, cocoa and dried fruit.

This Regulation lays down the maximum levels of the said substance for cereals, cereal products, raisins, roasted coffee, wine, grape juice, spices, liquorice and food for children.

The tolerable weekly intake (TWI) of ochratoxin A is 120 ng/kg body weight.

Patulin

Patulin is a mycotoxin produced by several types of fungus. It may be found in fruit juice, especially apple juice.

The provisional maximum tolerable daily intake for this substance is 0.4 ?g/kg body weight (bw).

Fusarium toxins

A variety of Fusarium fungi produces a number of mycotoxins * of the trichothecenes class, such as deoxynivalenol (DON), nivalenol (NIV), T-2 toxin, HT-2 toxin and some other toxins (zearalenone and fumonisins). Fusarium fungi are commonly found on cereals grown in the temperate regions of America, Europe and Asia. Several of the Fusarium fungi are capable, to a variable degree, of producing two or more of these toxins.

The SCF has adopted six opinions laying down a tolerable daily intake (TDI for these toxins. It established a TDI for deoxynivalenol of 1 ?g/kg body weight, a provisional TDI of 0.2 ?g/kg body weight for zearalenone, a TDI of 2 ?g/kg body weight for fumonisins, a provisional TDI of 0.7 ?g/kg body weight for nivalenol, a combined provisional TDI of 0.06 ?g/kg body weight for T-2 and HT-2 toxins and an opinion on trichothecenes as a group.

On the basis of these scientific opinions and the assessment of the dietary intake, this Regulation lays down the maximum levels for deoxynivalenol, zearalenone and fumonisins.

The Regulation states that the presence of T-2 and TH-2 may also be a public health concern. The Commission will therefore develop a reliable and sensitive method for detecting these toxins and continue to study the causes of their appearance in cereals and in particular in oats.

Lead

Lead absorption may constitute a serious risk to public health, since it may slow cognitive development, impair intellectual performance in children and increase blood pressure and cardiovascular diseases in adults.

The maximum level of lead in fish has been changed to 0.30 mg/kg fresh weight by the EU, taking account of the discussions within the .

Cadmium

Cadmium absorption also constitutes a risk to humans, since it may induce kidney dysfunction, skeletal damage and reproductive disorders.

Mercury

This substance may induce alterations in the normal development of the brain of infants and at higher levels may induce neurological changes in adults. It mostly contaminates fish and fishery products.

Methylmercury is the chemical form of mercury which is the greatest source of concern.

3-monochloropropane-1,2-diol (3-MCPD)

This carcinogenic substance is formed under certain conditions during food processing. In particular, it may be produced during manufacture of the food ingredient “hydrolysed vegetable protein” by the acid hydrolysis method.

By adjusting the production processes, the amount of 3-MCPD in the above-mentioned product has been reduced significantly. The main sources of exposures through food are soya sauce and soya sauce-based products.

The TDI is 2 µg/kg body weight.

Dioxins and dioxin-type polychlorinated biphenyls (PCBs)

Dioxins are chemicals resulting from certain natural phenomena (volcanism, forest fires) or industrial processes (manufacturing of pesticides, metals or paint, paper bleaching, incineration, etc.).

PCBs are chemicals which are widespread and found in, inter alia, building materials, lubricants, waterproofing agents and paints. Both types of substance may cause serious health problems, including cancer, immune and nervous system disorders, liver damage and sterility.

The TWI is 14 pg World Health Organisation toxic equivalent (WHO-TEQ)/kg body weight.

Polycyclic aromatic hydrocarbons (PAHs)

Some of these are genotoxic carcinogens. Contamination by PAHs may occur during smoking, heating and drying of food or through environmental pollution, especially in fish.

In order to protect public health, maximum levels are necessary for benzo(a)pyrene in certain foods containing fats and oils and in foods where smoking or drying processes might cause high levels of contamination. Maximum levels are also necessary in foods where environmental pollution may cause high levels of contamination, in particular in fish and fishery products, resulting, for example, from oil spills caused by shipping.

Inorganic tin

This type of tin may be found in tinned food and canned drinks. It may provoke gastric irritation in certain susceptible groups of the population.

For tinned foods other than beverages, the maximum level was laid down at 200 mg/kg. For canned beverages, the maximum level was laid down at 100 mg/kg.

BAN ON MIXING

Foods which comply with the maximum levels of contaminants may not be mixed with other foods which exceed these limits. By the same token, foods which must be sorted or subjected to other physical treatments to reduce the level of contamination may not be mixed with foods which comply with the maximum levels for human consumption.

SPECIFIC RULES ON LABELLING

Labelling on groundnuts, other oilseeds, nuts, dried fruit, rice and maize put on the market as foods which have to be subjected to sorting or other physical treatment before human consumption must include the wording: “product must be subjected to sorting or other physical treatments to reduce aflatoxin contamination before human consumption or use as an ingredient in foodstuffs”.

In addition, labelling on groundnuts, other oilseeds, products derived from oilseeds and cereals must indicate the use and lot identification code. If it is not clearly specified that they are not intended for human consumption, the maximum levels laid down by this Regulation apply.

The maximum levels defined in the Annex for lettuces “grown in the open” apply.

EXCEEDING OF THE LIMITS

Aflatoxins

Groundnuts, other oilseeds, nuts, dried fruit, rice and maize which exceed the maximum limits specified in the Annex to the Regulation may be placed on the market as long as:

  • they are not intended for human consumption;
  • they do not exceed the maximum limits for these products which are to be sorted before human consumption..

Nitrates

Derogations may be granted to some countries for exceeding the maximum level of nitrates. They cover production and consumption in the territory of the country concerned of products such as fresh spinach (Belgium, Ireland and the United Kingdom) and lettuces (Ireland and the United Kingdom).

Dioxins and dioxin-like PCBs

This Regulation grants Finland and Sweden a derogation for exceeding the levels of dioxins and dioxin-type PCBs until 31 December 2011 for the following products, but only for production and consumption in the territory of salmon, herring, river lamprey, trout, char and vendace roe from the Baltic.

CONTROL AND SUPERVISION

The Member States are responsible for supervising and controlling the level of nitrates in vegetables, especially green leaf vegetables.

They shall communicate the results to the Commission by 30 June every year.

Moreover, they shall communicate to the Commission the result of surveys carried out on the presence of contaminants in food every year

DISPOSAL OF STOCKS

This Regulation permits stocks of food which exceed the maximum levels of contaminants placed on the market before the date of entry into force of the respective limits for the contaminants to be disposed of.

MAXIMUM LEVELS IN FOOD FOR CHILDREN

This Regulation lays down maximum levels as low as possible for food for babies and for infants and young children in order to protect the health of this vulnerable population group. These maximum levels also apply to food for infants and young children covered by Directive 2006/125/EC and Directive 2006/141/EC.

The maximum levels for infants and young children according to this Regulation are:

  • nitrates: 200 mg/kg;
  • Aflatoxin B1: 0.10 µg/kg;
  • Aflatoxin M1: 0.025 µg/kg;
  • Ochratoxin A: 0.5 µg/kg and the same maximum level for dietary foods for specific medical purposes, specifically for infants;
  • Patulin: 10 µg/kg;
  • Deoxynivalenol: 200 µg/kg;
  • Zearalenone: 20 µg/kg and the same level for maize-based formulae for infants and young children;
  • Fumonisins: 200 µg/kg for maize-based formulae for infants and young children
  • Lead: 0.020 mg/kg fresh weight;
  • Inorganic tin: 50 mg/kg fresh weight and the same level for preparations for infant formulae and follow-on formulae and for canned dietary foods for special medical purposes specifically for infants (not including dried and powdered products);
  • benzo(a)pyrene: 1 µg/kg fresh weight and the same maximum level for formulae for infants and follow-on formulae and for dietary foods for special medical purposes specifically for infants.
Key terms used in the act
  • Mycotoxins Certain types of moulds of fungoid origin produce powerful poisons, especially the family of mycotoxins. The term mycotoxin comes from the Greek (mycos), which means fungus, and the Latin (toxicum), which means poison. It designates toxic chemical substances produced by certain moulds which develop on certain foodstuffs, particularly cereals.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1881/2006

9.1.2007

Applicable as of 1.3.2007

OJ L 364 of 20.12. 2006

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

Regulation (EC) No 1126/2007

30.9.2007

OJ L 255 of 29.9.2007

Regulation (EC) No 629/2008

23.7.2008

OJ L 173 of 3.7.2008

Regulation (EC) No 165/2010

9.3.2010

OJ L 50 of 27.2.2010

The successive amendments and corrections to Regulation (EC) No 1881/2006 have been incorporated in the original text. This consolidated versionis of documentary value only.

Related Acts

METHODS OF SAMPLING AND METHODS OF ANALYSIS

Regulation (EC) No 333/2007 laying down methods of sampling and analysis for the official controls for the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs [Official Journal L 88 du 29.3.2007].

Commission Regulation (EC) No 1883/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of levels of dioxins and dioxin-type PCBs in certain foodstuffs [Official Journal L 364 of 20.12.2006].

Commission Regulation (EC) No 1882/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of the levels of nitrates in certain foodstuffs [Official Journal L 364 of 20.12.2006].

Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in food [Official Journal L 70 of 4.3.2006].
Amended by:
Regulation (EU) No 178/2010 [Official Journal L 52 of 3.3.2010].

IMPORTS

Commission Regulation (EC) No 1152/2009 of 27 November 2009 imposing special conditions governing the import of certain foodstuffs from certain third countries due to contamination risk by aflatoxins and repealing Decision 2006/504/EC [Official Journal L 313 of 28.11.2009].

Residues of veterinary medicinal products in foodstuffs of animal origin

Residues of veterinary medicinal products in foodstuffs of animal origin

Outline of the Community (European Union) legislation about Residues of veterinary medicinal products in foodstuffs of animal origin

Topics

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

Internal market > Pharmaceutical and cosmetic products

Residues of veterinary medicinal products in foodstuffs of animal origin

Document or Iniciative

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (Text with EEA relevance).

Summary

This Regulation aims at defining the rules and procedures to be applied when setting maximum residue limits for medicinal products in foodstuffs of animal origin in order to guarantee food safety.

Scope

This Regulation establishes on the one hand the maximum concentration of a residue of a pharmacologically active substance which may be permitted in foodstuffs of animal origin and on the other defines the level of residues of medicinal products for which a maximum limit has not yet been set.

Active principles of biological origin used in immunological veterinary medicinal products and substances covered by the Regulation on contaminants in foodstuffs for human consumption are excluded from its scope.

Maximum residue limits

Substances intended for use in veterinary medicinal products

The European Medicines Agency issues an opinion on any application relating to a pharmacologically active substance intended for use in veterinary medicinal products. This opinion consists of a scientific risk assessment and risk management recommendations. The Agency ensures that the final opinion of the Committee is given within 210 days.

Other substances requiring an opinion from the Agency

The European Commission or Member States may submit to the Agency a request for an opinion on maximum residue limits in the following cases:

  • the use of the substance in question is authorised in a third country but has not been subject to an application for the establishment of a maximum residue limit by the Agency;
  • the substance in question is contained in a medicinal product but has not been subject to an application for the establishment of a maximum residue limit by the Agency.

The Agency shall ensure that the opinion of the Committee concerning a relevant request from the European Commission or Member States is given within 210 days.

Once the opinions have been published, the Commission, in consultation with the Agency, Member States and interested parties, shall adopt the following measures:

  • methodological principles to be applied following the risk assessment and recommendations described above;
  • rules concerning the use of a maximum residue limit for medicinal products.

Classification

The Commission classifies the pharmacologically active substances which have already been subject to an opinion from the Agency. This classification includes a list of pharmacologically active substances and the therapeutic classes to which they belong, as well as the following:

  • a maximum residue limit;
  • a provisional maximum residue limit (for a period not exceeding five years);
  • the absence of the need to establish a maximum residue limit;
  • a prohibition on the administration of a substance.

A maximum residue limit may be provided if scientific data is incomplete, as long as the substance does not constitute a hazard to human health. It is presupposed that the residues do not constitute a hazard to the health of individuals.

It is possible to obtain an emergency authorisation for a veterinary medicinal product or biocide product by making an application to the Agency to carry out an accelerated procedure for the assessment of the maximum residue limit. The Agency shall ensure that the final opinion of the Committee is given within 120 days.

Reference points for action

The Commission can establish reference points for action for residues of pharmacologically active substances which are not classified.

Reference points for action are established in consultation with official control laboratories in accordance with a method corresponding to Community requirements.

A request for a risk assessment may be sent to the European Food Safety Authority (EFSA) in order to determine whether the reference points for action are adequate.

Various provisions

The Agency consults Community reference laboratories using analytical methods which are appropriate for analysing residues. The aim of this consultation is also to achieve harmonised controls in order to provide information on the methods used during the authorisation procedure for official control laboratories.

When placed on the market, foodstuffs of animal origin which contain residues of medicinal products at a level exceeding the limit established by this Regulation or containing an unclassified substance are not considered as complying with the legislation.

This Regulation repeals Regulation (EC) No 2377/90. The Commission includes pharmacologically active substances and their classification from Regulation (EC) No 2377/90 in Annexes I to IV.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 470/2009

6.7.2009

OJ L 152 of 16.6.2009

Related Acts

Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin [Official Journal L 15 of 20.1.2010].

Materials and articles in regenerated cellulose film

Materials and articles in regenerated cellulose film

Outline of the Community (European Union) legislation about Materials and articles in regenerated cellulose film

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 in regenerated cellulose film

Document or Iniciative

Commission Directive 2007/42/EC of 29 June 2007 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs.

Summary

This Directive is a specific directive provided for by Regulation (EC) No 1935/2004 concerning materials and articles intended to come into contact with food.

Scope

It applies to regenerated cellulose film which constitutes a finished product in itself, or forms part of a finished product containing other materials and which are intended to come into contact or are placed in contact with foodstuffs.

It does not apply to synthetic casings of regenerated cellulose.

Description

Regenerated cellulose film is defined as a thin sheet obtained from a refined cellulose derived from unrecycled wood or cotton. To meet technical requirements, suitable substances may be added either in the mass or on the surface. Regenerated cellulose film may be coated on one or both sides.

The regenerated cellulose films covered by this Directive belong to one of the following categories:

  • uncoated regenerated cellulose film;
  • coated regenerated cellulose film with coating derived from cellulose; or
  • coated regenerated cellulose film with coating consisting of plastics.

Authorised substances and restrictions

The Directive lays down a positive list of substances authorised in the manufacture of regenerated cellulose film with restrictions of use (see Annex II).

Regenerated cellulose films which are uncoated or coated with plastics may be manufactured with substances other than those specified in Annex II if they are employed as colouring matter or as adhesives, provided that there is no trace of migration of the substances into or onto foodstuffs.

Regenerated cellulose films which are coated with plastics shall comply with the provisions laid down by Regulation (EU) No 10/2011 concerning plastic materials and articles intended to come into contact with foodstuffs.

Printed surfaces of regenerated cellulose film shall not come into contact with the foodstuffs.

Marketing and labelling

At the marketing stages other than the retail stages, materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs shall be accompanied by a written declaration in accordance with Regulation (EC) No 1935/2004. However, materials and articles which, by their nature, are clearly intended to come into contact with foodstuffs are not subject to this obligation.

Where special conditions of use are indicated, the material or article made of regenerated cellulose film shall be labelled accordingly.

Context

This Directive codifies and repeals Commission Directive 93/10/EEC of 15 March 1993 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs and its amendments.

REFERENCES

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

Directive 2007/42/EC

20.7.2007

OJ L 172 of 30.6.2007

Recycled plastic materials and articles

Recycled plastic materials and articles

Outline of the Community (European Union) legislation about Recycled 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

Recycled plastic materials and articles

Document or Iniciative

Commission Regulation (EC) No 282/2008 of 27 March 2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 2023/2006.

Summary

This Regulation lays down specific measures for recycled plastic materials and articles, supplementing Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food.

Scope

This Regulation covers recycled plastic materials and articles which may come partially or totally into contact with food.

This Regulation does not apply to recycled plastic materials and articles:

  • made with monomers and substances derived from chemical depolymerization of plastic materials and articles;
  • made from unused production offcuts or process scraps;
  • in which the recycled plastic is used behind a plastic functional barrier *.

The materials and articles covered by this Regulation are subject to Regulation (EU) No 10/2011 on plastic materials intended for food packaging.

Requirements for recycled plastic materials and articles

The recycled plastic used for the manufacture of materials and articles covered by this Regulation must be obtained from an authorised recycling process. The said process is to be managed using a quality assurance system which complies with the rules laid down in the Annex of Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food.

Conditions for the authorisation of recycling processes

Authorisation may be granted if recycling processes comply with the following conditions:

  • the quality of plastic input must be characterised and controlled;
  • the plastic input must originate from plastic materials and articles that have been manufactured in accordance with Community legislation on plastic food contact materials and articles;
  • the recycling process must be able to guarantee that there can be no contamination or that it is reduced to a concentration that does not pose a risk to human health;
  • the conditions of use of recycled plastic must guarantee that the final materials and articles do not release into food components in a quantity likely to endanger human health or to bring about an unacceptable change in the composition of the food, or to bring about a deterioration in the organoleptic characteristics thereof.

Applications for authorisation of recycling processes

Applications for authorisation for a recycling process are to be made to the competent authority of a Member State accompanied by a technical dossier containing the information described in the guidelines for the safety assessment of a recycling process prepared by the European Food Safety Authority.

The Member State sends the application to the Authority which is responsible for assessing whether the said process meets the above conditions. Following a transitory phase, the Authority will have a period of six months from receipt of the application to give its opinion.

The Commission shall take into account the opinion of the Authority and adopt a Decision that it will send to the applicant. In this Decision, it will grant or refuse authorisation of the recycling process.

Community register

The Commission shall maintain a register of authorised recycling processes. The register shall be made available to the public.

Official control

Recycling plants and converters shall be subject to official controls. These controls aim at verifying that the recycling processes correspond to the processes for which authorisation was granted and that the quality assurance system is in place.

The authorisation holder shall notify the competent authority in the Member State about the recycling or manufacturing site in which the authorised recycling process is being applied. Member States shall send this information to the Commission who will keep updated a register of recycling sites in the Community and third countries.

Labelling of recycled plastic materials and articles

Voluntary self-declaration of the recycled content in recycled plastic materials and articles shall follow the rules laid down in ISO 14021:1999 or equivalent.

Declaration of compliance and record keeping

In addition to the conditions laid down by Regulation (EU) No 10/2011, the declaration of compliance of recycled plastic materials and articles shall certify that the recycled plastic used comes from an authorised recycling process and shall bear the EC register number corresponding to the recycling process.

In addition to the conditions laid down by Regulation (EU) No 10/2011, the declaration of compliance for recycled plastic materials shall certify that:

  • the recycling process has been authorised. A precise indication of the EC register number for the process;
  • the plastic input, the recycling process and the recycled plastic meet the specifications for which the authorisation has been granted;
  • a quality assurance system is in place.
Key terms of the Act
  • Plastic functional barrier: a barrier composed of one or several layers of plastic material ensuring that the finished material or article does not release into food components in a quantity likely to:
    1. endanger human health, or
    2. bring about an unacceptable change in the composition of the food, or
    3. bring about a deterioration in the organoleptic characteristics thereof.

References

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

Regulation (EC) No 282/2008

17.4.2008

OJ L 86 of 28.3.2008

Extraction solvents used in foodstuffs

Extraction solvents used in foodstuffs

Outline of the Community (European Union) legislation about Extraction solvents used in 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

Extraction solvents used in foodstuffs

Document or Iniciative

Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients.

Summary

This Directive replaces Directive 88/344/EEC and establishes a single list of extraction solvents * for foodstuffs.

Extraction solvents

This Directive applies to extraction solvents used in the production of foodstuffs or food ingredients. It also applies to extraction solvents imported into the European Union (EU).

This Directive shall not apply to extraction solvents used in the production of food additives, vitamins and other nutritional additives (unless such food additives, vitamins or nutritional additives are listed in Annex I).

Use and marketing

Member States shall authorise the use on their territory of extraction solvents used in the production of foodstuffs or food ingredients. However, this is subject to compliance with conditions of use and permitted residues. Only extraction solvents listed in Annex I may be used.

Member States shall not prohibit, restrict or limit the marketing of a foodstuff or ingredient produced using an extraction solvent which meets the requirements of this Directive.

Water to which substances regulating acidity or alkalinity may have been added and other food substances which possess solvent properties are authorised as extraction solvents in the manufacture of foodstuffs or food ingredients.

Purity criteria

This Directive may, if necessary, establish specific purity criteria for the extraction solvents listed in Annex I, and in particular maximum permitted limits of mercury and cadmium.

The suspension or withdrawal of authorisation

A Member State may temporarily suspend or restrict an authorisation granted for an extraction solvent. To do this, the Member State must have grounds justifying that the solvent in question represents a risk for human health. It shall inform the Commission and the other Member States of its decision without delay.

The Commission shall examine the grounds cited as soon as possible and express an opinion. If appropriate, the Commission shall approve the measures taken by the Member State or supplement them with appropriate measures.

Labelling

This Directive lays down labelling requirements including:

  • the commercial name as indicated in Annex I;
  • a clear indication that the extraction solvent is of a quality suitable for use for the extraction of food or food ingredients;
  • the number of the batch or lot;
  • the commercial name of the manufacturer or packer;
  • the net quantity;
  • if necessary, the special storage conditions or conditions of use.

There may be exemptions from these labelling rules. Only the first two particulars (the commercial name and use) may appear on the label if the extraction solvents are accompanied by commercial documents for the batch or lot which include the remaining information.

The particulars must be easily visible, clearly legible and indelible. They must be expressed in a language which can be easily understood by the purchaser.

Key terms of the Act
  • Solvent: any substance for dissolving a foodstuff or any component thereof, including any contaminant present in or on that foodstuff.
  • Extraction solvent: a solvent which is used in an extraction procedure during the processing of raw materials, of foodstuffs, or of components or ingredients of these products and which is removed but which may result in the unintentional, but technically unavoidable, presence of residues or derivatives in the foodstuff or food ingredient.

References

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

Directive 2009/32/EC

26.6.2009

JO L 141 of 6.6.2009

Materials and articles containing vinyl chloride monomer

Materials and articles containing vinyl chloride monomer

Outline of the Community (European Union) legislation about Materials and articles containing vinyl chloride monomer

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 containing vinyl chloride monomer

Document or Iniciative

Council Directive 78/142/EEC of 30 January 1978 on the approximation of the laws of the Member States relating to materials and articles which contain vinyl chloride monomer and are intended to come into contact with foodstuffs.

Summary

Materials and articles which are intended to come into contact with foodstuffs may not transfer certain constituents to these materials and articles in quantities liable to endanger human health.

In order to guarantee that these foodstuffs contain no trace of vinyl chloride monomer detectable by a method by a general Community method of analysis, materials and articles intended to come into contact with foodstuffs must comply with this Directive. Thus materials and articles:

  • must not contain vinyl chloride monomer in quantities above one milligram per kilogram in the final product; and
  • must not transfer vinyl chloride monomer to foodstuffs in quantities above 0.01 mg/kg in the final product.

References

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

Directive 78/142/EEC

1.2.1978

26.11.1979

OJ L 44 of 15.2.1978

Related Acts

Commission Directive 80/766/EEC of 8 July 1980 laying down the Community method of analysis for the official control of the vinyl chloride monomer level in materials and articles which are intended to come into contact with foodstuffs [Official Journal L 213 of 16.8.1980].

This Directive lays down the Community method of analysis for the determination of the vinyl chloride monomer level in materials and articles which are intended to come into contact with foodstuffs. This method meets the criteria laid down in the annex to Directive 78/142/EEC.

Commission Directive 81/432/EEC of 29 April 1981 laying down the Community method of analysis for the official control of vinyl chloride released by materials and articles into foodstuffs [Official Journal L 167 of 24.6.1981].

This Directive lays down the Community method of analysis for determining the quantity of vinyl chloride released by materials and articles into foodstuffs.