Tag Archives: Toxic substance

Undesirable substances in animal feed

Undesirable substances in animal feed

Outline of the Community (European Union) legislation about Undesirable substances in animal feed


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

Food safety > Animal nutrition

Undesirable substances in animal feed

Document or Iniciative

Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed [See amending act(s)].


This Directive sets maximum levels to limit as far as possible the presence of undesirable substances and products in animal feed put into circulation within the European Union (EU).

Undesirable substances

“Undesirable substance” means any substance or product, with the exception of pathogenic agents, which is present in and/or on the product intended for animal feed and which presents a potential danger to animal or human health or to the environment or could adversely affect livestock production. The range of substances covered by the Directive comprises arsenic, lead, mercury, dioxin and certain mustards.

This Directive applies to all products intended for animal feed, including raw materials for feed, additives and complementary feedingstuffs.

List of undesirable substances

The Directive lays down a list of undesirable substances, for which it sets limit values above which their presence in animal feeds is forbidden (see Annex I to the Directive). This list is regularly updated in the light of technical progress.


When these maximum levels are exceeded, Member States, in cooperation with the economic operators concerned, must carry out investigations to identify the sources of the substances concerned. They must then inform the Commission of the outcome of these investigations and the measures taken to reduce the level of the substances or eliminate them.


To prevent fraud, the Directive prohibits mixing a product containing undesirable substances with the same product or other products in order to dilute it.

Temporary provisions

There can be no derogations from the Directive. However, where a danger to human or animal health or to the environment becomes apparent, Member States may provisionally take more stringent measures, reducing the maximum level set in the Directive.


Following the dioxin crisis in the late 1990s, the EU made many changes to European undesirable substances in order to improve food security and to better protect human and animal health and the environment.

Directive 2002/32/EC replaces Directive 1999/29/EC as from 1 August 2003.


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

Directive 2002/32/EC



OJ L 140, 30.5.2002

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

Regulation (EC) No 219/2009


OJ L 87, 31.3.2009

The successive amendments and corrections to Directive 2002/32/EC have been incorporated into the original text. This consolidated versionis of documentary value only.

Related Acts

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

In the context of the review of food hygiene legislation (“hygiene package”), this Regulation re-organises official controls of food and feed so as to integrate controls at all stages of production and in all sectors. The Regulation defines the European Union’s duties as regards the organisation of these controls, as well as the rules which must be respected by the national authorities responsible for carrying out the official controls, including coercive measures adopted in the event of failure to comply with Community law.

Other substances: protection of groundwater

Other substances: protection of groundwater

Outline of the Community (European Union) legislation about Other substances: protection of groundwater


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

Other substances: protection of groundwater

Document or Iniciative

Council Directive 80/68/EEC of 17 December 1979 on the protection of groundwater against pollution caused by certain dangerous substances [See amending acts].


The purpose of this Directive is to prevent the discharge of certain toxic, persistent and bioaccumulable substances into groundwater.

The following are not covered:

  • discharges of domestic effluents from isolated dwellings;
  • discharges containing substances listed in Directive 80/68/EEC in very small quantities and concentrations;
  • discharges of matter containing radioactive substances.

There are two lists of dangerous substances drawn up for the protection of groundwater:

  • direct discharge of substances in List I is prohibited. This list includes organohalogen, organophosphorus and organotin compounds, mercury and cadmium and their compounds, and hydrocarbons and cyanides;
  • discharge of substances in List II must be limited. This list includes certain metals such as copper, zinc, lead and arsenic, and other substances such as fluorides, toxic or persistent organic compounds of silicon, and biocides and their derivatives not appearing in List I.

All indirect discharges of substances in List I and all direct or indirect discharges of substances in List II are subject to prior authorisation. Such authorisation:

  • is granted after an investigation into the receiving environment;
  • is granted for a limited period and subject to regular review;
  • lays down the conditions that have to be met for discharges. If they have not been or cannot be met, the authorisation is withdrawn or refused.

Monitoring of compliance with these conditions and of the effects of discharges on groundwater is the responsibility of the competent authorities of the Member States.

The Directive provides for exceptions, under certain conditions, to the ban on discharges of substances in List I.

It also lays down special rules for artificial recharges of groundwater intended for public water supplies.

The competent authorities of the Member States must keep an inventory of authorisations:

  • of discharges of substances in List I;
  • of direct discharges of substances in List II;
  • of artificial recharges for the purpose of groundwater management.

The Member States concerned must inform one another in the event of discharges into transboundary groundwater.

Member States may introduce more stringent measures than those laid down in this Directive.

Every three years, reports by the Member States on the implementation of Directive 80/68/EEC and other relevant Directives, drawn up on the basis of a questionnaire or outline drafted by the Commission in accordance with the procedure laid down in Directive 91/692/EEC. The Commission is responsible for publishing a report on the basis of this information.


Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Directive 80/68/EEC 19.12.1979 19.12.1983 OJ L 20 of 26.01.1980
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Directive 91/692/EEC 23.12.1991 01.01.1993 OJ L 377 of 31.12.1991

Related Acts

of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy [Official Journal L 327 of 22.12.2000].
This Directive repeals Directive 80/68/EC as of 21 December 2013.

Commission Decision 92/446/EEC of 27 July 1992 concerning questionnaires relating to Directives in the water sector [Official Journal L 247 of 27.08.1992].

This Decision draws up the outlines of questionnaires needed to monitor the implementation of and compliance with the provisions of all Directives in the water sector, including Directive 80/68/EEC.


Combating invasive species

Combating invasive species

Outline of the Community (European Union) legislation about Combating invasive species


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

Environment > Protection of nature and biodiversity

Combating invasive species

Document or Iniciative

Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions of 3 December 2008 – Towards an EU strategy on invasive species [COM(2008) 789 final – Not published in the Official Journal].


Invasive species are animal or plant species that have become established in areas that are not their normal habitat and have become a threat. These non-native species may cause serious damage to ecosystems, crops, disrupt local ecology, impact human health and produce serious economic effects.

The main vectors introducing invasive species are directly or indirectly related to trade and transport. Climate change and the deterioration of natural habitats foster their spread. At present, the European Union (EU) has no specific instrument to tackle this issue.

At international level, a three-stage approach has been adopted by the Commission, which recommends measures based on:

  • prevention, to limit introductions resulting from trade which, in particular, necessitates stronger border controls;
  • early detection and rapid eradication which require monitoring and early warning programmes;
  • control and/or confinement if the invasive species is already established, as well as the implementation of coordinated action.

The legislation in force, particularly the plant health Directive, animal health legislation and the CITES Regulation, and a number of programmes already provide instruments to tackle the threat constituted by invasive species. However, coverage of the problem is still partial and does not enable coordinated implementation to take place.

Four strategic options can be envisaged to tackle the problem of invasive species in the EU:

  • business as usual: if no steps are taken, invasive species will continue to establish themselves and an increase in ecological, economic and social consequences is to be expected, as well as an increase in costs;
  • maximising existing instruments and voluntary measures: legal requirements would remain unchanged but stakeholders would consciously choose to tackle the problem of invasive species under the legislation in force. The Commission stresses however that the level of response may vary considerably from one Member State to another;
  • adapted existing legislation: a similar option to the above, but including the amendment of existing legislation on plant/animal health to cover a broader range of potentially invasive species;
  • the creation of a specific Community instrument: this option would in particular include an obligation for Member States to carry out border controls and to exchange information on invasive species. The Commission considers that this option would be the most effective.

Several horizontal issues related to invasive species should also be tackled. It is therefore important to build a sense of responsibility amongst citizens, authorities and industries with regard to the problem, to intensify research in order to gain a better understanding of the risks and to undertake bilateral action with third countries, in particular under development policy.


Combating invasive species forms part of the Action Plan for biodiversity which recognises the necessity to prepare a comprehensive strategy at EU level to reduce their impact on biological diversity in Europe. The Commission intends to present such a proposal in 2010.

Release of N-nitrosamines from rubber teats

Release of N-nitrosamines from rubber teats

Outline of the Community (European Union) legislation about Release of N-nitrosamines from rubber teats


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

Release of N-nitrosamines from rubber teats

Document or Iniciative

Commission Directive 93/11/EEC of 15 March 1993 concerning the release of N-nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers.


This Directive is a specificmeasure within the meaning of Article 5 of Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food.

Elastomer or rubber teats and soothers are capable of releasing N-nitrosamines and N-nitrosable substances (substances likely to be transformed into N-nitrosamines) which, by virtue of their toxicity, pose a threat to human health.

Accordingly, the migration of substances must not exceed the following limits:

  • 0.01 mg of the total quantity of N-nitrosamines released per kg (parts of elastomer or rubber teats and soothers)
  • 0.1 mg of the total quantity of N-nitrosatable substances (parts of elastomer or rubber teats and soothers).

These limits must be checked by means of a test, subject to the conditions set out in the annex to this Directive. The analytical method to be employed is also laid down in this annex.

Teats and soothers which do not comply with this Directive are prohibited from 1 April 1995.


Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 93/11/EEC



OJ L 93 of 17.4.1993

Stockholm Convention on persistent organic pollutants

Stockholm Convention on persistent organic pollutants

Outline of the Community (European Union) legislation about Stockholm Convention on persistent organic pollutants


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

Environment > Air pollution

Stockholm Convention on persistent organic pollutants (POPs)

Document or Iniciative

Council Decision 2006/507/EC of 14 October 2004 concerning the conclusion, on behalf of the European Community, of the Stockholm Convention on Persistent Organic Pollutants.


The Stockholm Convention seeks to limit pollution by persistent organic pollutants (POPs). It defines the substances in question, and also defines the rules governing the production, importing and exporting of those substances.


Persistent organic pollutants are chemical substances that possess certain toxic properties and, unlike other pollutants, resist degradation. POPs are particularly harmful for human health and the environment. They accumulate in living organisms, are transported by air, water and migratory species and accumulate in terrestrial and aquatic ecosystems. Pollution caused by POPs is a cross-border problem which makes international action is indispensable.


The Stockholm Convention covers 12 priority POPs produced intentionally or unintentionally. These substances are formed unintentionally by a wide variety of sources, such as residential combustion systems and waste incinerators.

These 12 priority POPs are aldrin, chlordane, dichlorodiphenyltrichlorethane (DDT), dieldrin, endrin, heptachlor, mirex, toxaphene, polychlorobiphenyls (PCBs), hexachlorobenzene, dioxins and furanes.

Initially the Convention aims at prohibiting production and use of nine POPs and minimising production and use of a tenth substance. In the case of the last two POPs, the objective is to minimise their unintentional production and release into the environment. The rules laid down in the Convention do not apply to quantities of a chemical to be used for laboratory-scale research.

Institutional bodies

Three bodies have been set up to implement the Convention at international level:

  • The Conference of the Parties: This is the principal body, consisting of all the Parties to the Convention plus, where appropriate, observers. It lays down the rules on the implementing procedures and is responsible for major decisions, such as addition of a new substance to the Convention and approval of exemptions;
  • The Persistent Organic Pollutants Review Committee: This committee, made up of specialists, examines proposals to add new substances to the Convention;
  • The Secretariat: This body is responsible principally for administrative tasks.

Import/export of POPs

The Convention provides for ending imports and exports of banned POPs. However, chemicals classified as POPs may be imported under certain circumstances:

  • for environmentally sound disposal of existing POPs (destruction of waste, etc.);
  • if an exemption has been granted authorising production and use of the substances in question.

Exports are authorised:

  • for environmentally sound disposal of existing POPs (destruction of waste, etc.);
  • to a party granted an exemption from the Convention to use the substance in question;
  • to States which have not signed the Convention.

In the latter case, the importing State must provide annual certification to the exporting Party. This certificate must specify, inter alia, the intended use of the chemical and including a commitment from the importing State to protect human health and the environment and to take waste management measures, including action to ensure irreversible elimination of the substance classified as a POP.

Unintentional production of POPs

The goal is to minimise and, where feasible, eliminate unintentional production and release of POPs. To this end, the Parties to the Convention are required to develop a national, regional or subregional action plan. This must form part of the overall plan for implementing the Convention. The plan must include an evaluation of releases, an evaluation of the efficacy of the existing laws and policies on management of such releases and strategies for meeting the objectives of the Convention.

The development and use of modified or substitute materials, product and processes must be encouraged in order to avoid unintentional production of POPs. The Convention includes general guidelines on best available techniques and best environmental practices for preventing or minimising releases. It also provides for measures to reduce or eliminate releases containing POPs from stockpiles and wastes.


The Convention allows certain exemptions from the provisions on elimination or minimisation of production or use of these substances and, consequently, from the rules on imports and exports. Such exemptions are specific to each POP and are defined, case by case, in the Annexes to the Convention.

The exemptions are entered in a register open to the public and are valid for five years. They may be extended by the Conference of the Parties, based on a report submitted to the Conference by the Party concerned justifying the continuing need for the exemption. However, when there are no longer any Parties registered for a particular type of exemption, no new registrations will be accepted for that exemption.

Implementation by the Parties

The Parties must develop a plan for fulfilling their obligations under the Convention and transmit it to the Conference. To make it easier to exchange information, each Party must designate a national focal point. Since POPs are a cross-border issue, the Parties are encouraged to cooperate at various levels, including regional or subregional, in order to facilitate the preparation, application and updating of their plans.

It is also important to monitor POP trends in the environment and their effects on public health and to encourage research and development.

Addition of new substances

At the request of any Party, the Review Committee examines all proposals to add new POPs to those already listed under the Convention. Such requests must be accompanied by the specified information stating the reasons for the proposal. This includes proof of persistence, bioaccumulation, potential for spreading and of the adverse effects on human health and the environment. Where it is decided that a proposal meets the selection criteria, the Committee re-examines the proposal, taking account of any relevant additional information received, and draws up a draft description of the risks, and if required, a risk management assessment. On the basis of these assessments, the Committee recommends that the Conference of the Parties should or should not consider including the chemical in annexes A, B and/or C. The final decision is taken by the Conference of the Parties.

Financial resources and technical assistance

Each Party contributes to the financial resources for implementation of the Convention, notably via measures and activities at national or regional level forming part of implementation plans. Developing countries and countries with economies in transition could have financial and technical difficulties with application of the Convention. Developed countries should make their contribution via a mechanism set up by the Convention to attempt to resolve this problem by providing extra financial resources. Another possible form of aid for developing countries and economies in transition is the technological support provided by the developed countries.

Rules on information

Members of the public, politicians and the chemical industry must be kept informed and made aware of the risks posed by POPs and of the rules on the subject. Measures such as appropriate training for the individuals concerned are envisaged. Effective communication between the Parties is also essential, principally via the Secretariat for the Convention.

Settlement of disputes

Disputes between Parties over interpretation or application of the Convention are either settled by arbitration or referred to the International Court of Justice. The plaintiff may choose the procedure. However, if the plaintiff is a regional or economic integration organisation it must follow the arbitration procedure alone.

Failure to comply

The Convention will have a mechanism for identifying non-compliance with the Convention and procedures for dealing with such cases.


Parties may withdraw from the Convention three years after it enters into force through a written withdrawal. A minimum period of one year from the receipt of the withdrawal notification by the depositary must elapse before such withdrawals can take effect.


The Convention was adopted by 150 Governments, including those of the Member States of the European Union, and also by the Council, acting on behalf of the European Union, at a conference held in Stockholm from 22 to 23 May 2001.

The Convention entered into force on 17 May 2004.

The Stockholm Convention follows a series of measures taken at international level. In June 1998 the European Community signed the Aarhus Protocol on Persistent Organic Pollutants to the Geneva Convention on Long-range Transboundary Air Pollution (under the auspices of the United Nations Economic Commission for Europe (UN-ECE)). The Protocol currently covers 16 POPs, 12 of which come under this Convention.

This measure also fits into the broader context of the numerous international treaties and conventions concluded on the environment in recent years, such as the Rio Declaration on Environment and Development.


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

Decision 2006/507/EC


OJ L 209, 31.7.2006

Related Acts

Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC [OJ L 158 of 30.4.2004].
This 2004 Regulation seeks to supplement the EU’s already substantial legislation on the substances on the lists and shows a willingness to go beyond international obligations, especially in the field of chemical substances and waste management.
The Regulation specifically concerns the production, placing on the market, use, discharge and elimination of substances which are banned or restricted under the Stockholm Convention on POPs, or the UN-ECE Protocol on POPs. It seeks to establish, at European level, requirements for effective implementation of these two international agreements.

Council Decision 2004/259/EC of 19 February 2004 concerning the conclusion, on behalf of the European Community, of the 1988 Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants [OJ L 81 of 19.3.2004].
This Decision approves the 1998 Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants.
This United Nations-Economic Commission for Europe (UN-ECE) Protocol was signed by the EU and its Member States in June 1998. It relates to the same 12 POPs as the Stockholm Convention and to four other additional substances (pentabromodiphenyl ether, chlordecone, hexabromobiphenyl and hexachlorocyclohexane). These POPs have significant adverse effects on health or the environment as a result of their persistence, their bioaccumulation and their long-range transboundary atmospheric transport. The Protocol’s ultimate aim is to eliminate discharges, emissions and leaks of POPs. The Protocol categorically prohibits the production and use of certain products (aldrin, chlordane, chlordecone, dieldrin, endrin, hexabromobiphenyl, mirex and toxaphene). It provides for the elimination of other products at a later stage (DDT, heptachlor, hexachlorobenzene and polychlorobiphenyls (PCBs)).