Tag Archives: Human nutrition

Quality of drinking water

Quality of drinking water

Outline of the Community (European Union) legislation about Quality of drinking water

Topics

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

Environment > Water protection and management

Quality of drinking water

Document or Iniciative

Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption [See amending act(s)].

Summary

The Directive is intended to protect human health by laying down healthiness and purity requirements which must be met by drinking water within the European Union (EU).

Drinking water

The Directive applies to all water intended for human consumption apart from natural mineral waters and waters which are medicinal products.

General obligations

Member States shall ensure that such drinking water:

  • does not contain any concentration of micro-organisms, parasites or any other substance which constitutes a potential human health risk;
  • meets the minimum requirements (microbiological and chemical parameters and those relating to radioactivity) laid down by the Directive.

They will take any other action needed in order to guarantee the healthiness and purity of water intended for human consumption.

Quality standards

Member States shall lay down the parametric values corresponding at least to the values set out in the Directive. Where parameters are not set out in the Directive limit values must be laid down by the Member States if necessary to protect health.

Controls

The Directive requires Member States to regularly monitor the quality of water intended for human consumption by using the methods of analysis specified in the Directive, or equivalent methods. For this purpose they shall determine the sampling points and draw up monitoring programmes.

Corrective action and restrictions on use

Where the parametric values are not attained the Member States concerned shall ensure that the corrective action needed is taken as quickly as possible in order to restore water quality.

Regardless of compliance, or otherwise, with the parametric values, Member States shall prohibit the distribution of drinking water or shall restrict its use and shall take any action needed where that water constitutes a potential human health hazard. Consumers shall be informed of any such action.

Exceptions

The Directive shall provide the Member States with scope to provide for exemptions from the parametric values up to a maximum value, provided that:

  • the exemption does not constitute a human health hazard;
  • there is no other reasonable means of maintaining the distribution of drinking water in the area concerned;
  • the exemption must be as restricted in time as possible and not exceed three years (it being possible to renew the exemption for two further three-year periods).

Any exemption granted must be accompanied by a detailed justification except if the Member State concerned feels that failure to meet the limit value is not serious and may be quickly remedied. Water sold in bottles or containers may not be exempted.

Any Member State granting an exemption must inform the following thereof:

  • the population affected;
  • the Commission within a two-month period if the exemption covers the distribution of more than 1000 m³ per day on average, or supplies for more than 5000 persons.

Quality guarantees on the processes, equipment and materials

Neither the materials or substances used in new installations for preparing and distributing drinking water may not continue to be present in drinking water beyond a strictly necessary level.

Re-examination

At least every five years the Commission shall re-examine the parameters laid down by the Directive in the light of scientific and technical progress. It will be assisted in that process by a Committee comprising representatives of the Member States.

Information and reports

Every three years Member States shall publish a report on the quality of drinking water for its consumers. On the basis of those reports the Commission will, every three years, draw up a summary report on the quality of the water intended for human consumption within the Community.

Deadline for compliance

Within five years at the latest Member States shall take any action needed in order to guarantee that water quality complies with the Directive. In exceptional cases that period may be extended provided that it does not exceed three years.

Repeal

Directive 98/83/EC replaces Directive 80/778/EEC from 25 December 2003.

References

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

Directive 98/83/EC

25.12.1998

25.12.2000

OJ L 330 of 05.12.1998

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

Regulation (EC) No 596/2009

7.8.2009

OJ L 188 of 18.7.2009

The successive amendments and corrections to Directive 98/83/EC have been incorporated in the original text. This consolidated versionis for reference only.

Traceability and labelling of GMOs

Traceability and labelling of GMOs

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

Topics

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

Food safety > Animal nutrition

Traceability and labelling of GMOs

Document or Iniciative

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

Summary

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

Objectives

The European Union has two main objectives:

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

GMOS

This Regulation covers:

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

Labelling and traceability

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

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

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

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

GMOs or products containing GMOS

Operators must transmit the following information in writing:

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

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

This information must also be held for five years.

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

Products produced from GMOs

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

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

This information must also be held for five years.

GMO adventitious presence threshold

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

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

Context

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

References

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

Regulation (EC) No 1830/2003

07.11.2003

16.01.2004

OJ L 268, 18.10.2003

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

Regulation (EC) No 1137/2008

11.12.2008

OJ L 311, 21.11.2008

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

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].

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].