Tag Archives: Health risk

Animal by-products

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Animal by-products

Outline of the Community (European Union) legislation about Animal by-products

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

Animal by-products

Document or Iniciative

Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002.

Summary

This Regulation facilitates the efficient management of animal by-products whilst maintaining the high level of protection that is currently in place against risks to public and animal health and to the environment.

Products concerned

This Regulation shall apply to:

  • animal by-products * and derived products * which are not intended for human consumption;
  • products intended for purposes other than human consumption:
    • products of animal origin which may be destined for human consumption;
    • raw materials for the production of products of animal origin.

End point in the manufacturing chain

This Regulation introduces the notion of an “end point” in the manufacturing of animal by-products, beyond which they are no longer subject to the rules governing this type of product, since potential risks have been eliminated. Instead, the general rules on product safety are to apply. As an example, where animal fat produced by an incinerating factory is processed and the product of that transformation is used to produce plastics, the probability that the final product might transmit a significant biological risk is very slight.

Essential guarantees for public and animal health

Products of animal origin may be used outside the food chain for various purposes: skins for leather production, powdered milk to feed animals, and blood products in diagnostic medical devices. Such by-products may be a vector of diseases affecting human beings or animals when they are used in animal feedingstuffs or to produce technical products.

This Regulation preserves the basic guarantees introduced in 2003 against such risks. In particular, it maintains:

  • a risk-based categorisation of animal by-products which determines whether they may be used as animal feedingstuffs, for the manufacture of technical products or for other purposes, or whether they must be destroyed;
  • an obligation for Member States and operators to ensure that animal by-products are collected and disposed of as soon as possible;
  • the exclusion of products that are unfit for hum an consumption from the feed chain for farmed animals; and lastly
  • a ban on feeding animals of one species with material derived from the same species (“intra-species recycling ban”).

A more coherent legal framework

Animal by-products are used to produce cosmetics, medicines and diagnostic medical devices. When they are used for the manufacture of such products, they are subject to other provisions of European law. Slaughterhouses, milk factories and other food establishments manufacturing animal by-products are already bound by European legislation on human food or animal feedingstuffs, and are the subject of inspections in this regard.

This Regulation aims at improving coherency between other provisions of European law and the health rules applying to animal by-products. The potential risks are tackled with respect to the appropriate legislation, which avoids operators being exposed to unnecessary constraints.

Being based on experience gained, this Regulation clarifies under which circumstances and in what way environmental legislation shall apply to operations involving animal by-products. This legislation applies for example where the spreading of manure as a fertiliser has effects on soil and the groundwater table.

Comitology

The current categorisation of animal by-products may now be amended by the Commission under the comitology procedure. Prior to any change, a scientific organisation such as the European Food Safety Authority (EFSA) or the Scientific Committee for Consumer Products (SCCP) must assess the possible risks of a specific animal by-product for public and animal health.

Repeal

Regulation (EC) No 1774/2002 shall be repealed with effect from 4 March 2011.

Key terms of the Act
  • Animal by-products: entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption, including oocytes, embryos and semen.
  • Derived products: products obtained from one or more treatments, transformations or steps of processing of animal by-products.
Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 41/2009

10.2.2009

–

OJ L 16 of 21.1.2009

Undesirable substances in animal feed

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Undesirable substances in animal feed

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

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

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)].

Summary

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.

Investigations

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.

Mixtures

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.

Context

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.

References

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

Directive 2002/32/EC

30.5.2002

1.5.2003

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

20.4.2009

–

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.

Placing of plant protection products on the market

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Placing of plant protection products on the market

Outline of the Community (European Union) legislation about Placing of plant protection products on the market

Topics

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

Food safety > Plant health checks

Placing of plant protection products on the market

Document or Iniciative

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.

Summary

The Regulation confirms the importance that the European Commission places on a higher level of health and environmental protection, whilst seeking to harmonise the placing of plant protection products * on the market. Furthermore, it aims to improve agricultural production.

The scope of this Regulation covers plant protection products and their active substances *.

The Regulation lays down approval criteria for active substances. An active substance shall be approved if it fulfils the criteria detailed in points 2 and 3 of Annex II to the Regulation. These criteria relate to the efficacy of the substance, its composition, its characteristics, the methods of analysis available, the impact on human health and the environment, ecotoxicology and the relevance of metabolites and residues. As such, an active substance shall only be approved if it is not classified as category 1A or 1B mutagenic, carcinogenic or toxic for reproduction, and is not considered to have endocrine disrupting properties. Furthermore, an active substance which is considered to be a persistent organic pollutant, or as persistent, bioaccumulative and toxic, or even as a very persistent and very bioaccumulative substance, shall not be approved.

The first approval is valid for a limited period which cannot exceed ten years and may be subject to certain conditions or restrictions regarding, for example, the purity of the active substance, the intended crop and the category of user.

Authorisation to place plant protection products on the market remains the responsibility of Member States. Applications are submitted to the Member State where the product is intended to be placed on the market for the first time. Applications shall be accompanied by two dossiers containing all the information available to enable the potential effects of the plant protection product on human and animal health, and the possible impact on the environment, to be assessed. The information provided by the applicant or the producer may be protected by a confidentiality clause if it constitutes an industrial or trade secret.

The time required to examine the application for authorisation to place a plant protection product on the market is limited to a period of twelve months, commencing on the date that the Member State receives the application. During this period, the Member State shall check whether the product concerned satisfies the authorisation conditions. If further information is required, the Member State may extend the initial assessment period in order to allow the applicant time to provide it. This period may not exceed six months and shall expire when the Member State receives the additional information. Where at the end of that period, the applicant has not submitted the missing elements, the Member State shall inform the applicant that the application is inadmissible.

Authorisation for placing on the market is valid for 10 years and may be renewed. A Member State may review an authorisation at any time if it no longer complies with one of the pre-conditions for placing on the market. Should this be the case, a Member State may withdraw or amend the authorisation.

The principle of mutual recognition established in this Regulation enables the holder of an authorisation to place the product on the market in another Member State insofar as the agricultural, plant health and environmental conditions are comparable in the regions concerned. However, the Member State may provisionally limit or ban the movement of a product on its territory if the product in question presents a risk to human or animal health, or to the environment.

In order to ensure protection for certain crops, the Regulation enables the holder of an authorisation for a plant protection product which has already been authorised in the Member State concerned, to request that the authorisation be extended to minor uses not yet covered by that authorisation. These extensions of use are also covered by the principle of mutual recognition.

Member States shall update the information on authorised or withdrawn plant protection products at least once every three months. This information shall be accessible to the public.

A provisional authorisation may be granted for the placing on the market of plant protection products containing an active substance which has not yet been approved. The provisional authorisation shall be granted for a period not exceeding three years.

The classification, labelling and packaging of plant protection products is also subject to the requirements provided for by Directive 1999/45/EC regarding dangerous preparations. The packaging of the aforementioned products should prevent consumers from using the products incorrectly.

Member States shall carry out official controls in order to enforce compliance with this Regulation. They shall finalise and transmit to the Commission a report on the scope and the results of these controls within six months of the end of the year to which the report relates. The Commission shall call on experts to carry out general and specific audits in the Member States. The aim of these audits is to verify the official controls carried out by the Member States.

The Commission may adopt emergency measures in order to restrict or prohibit the use and/or sale of a plant protection product if it is likely to constitute a serious risk to human or animal health or the environment, and that such a risk cannot be contained by the Member State(s) concerned.

Context

On 14 June 2011, this Regulation shall repeal and replace:

  • Directive 79/117/EEC concerning prohibited plant protection products; and
  • Directive 91/414/EEC concerning authorised plant protection products.
Key terms of the Act
  • Plant protection product: products consisting of or containing active substances, safeners or synergists, and intended for one of the following uses:
    1. protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products;
    2. influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient;
    3. preserving plant products, in so far as such substances or products are not subject to special Community provisions on preservatives;
    4. destroying undesired plants or parts of plants, except algae unless the products are applied on soil or water to protect plants;
    5. checking or preventing undesired growth of plants, except algae.
  • Active substances: substances or micro-organisms, including viruses, having general or specific action against harmful organisms or on plants, parts of plants or plant products.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1107/2009

14.12.2009

–

OJ L 309 of 24.11.2009

Environmental issues of PVC

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Environmental issues of PVC

Outline of the Community (European Union) legislation about Environmental issues of PVC

Topics

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

Other

Environmental issues of PVC

The Commission assesses the impact of PVC waste on the environment and presents proposals for addressing the problems that may arise in this respect.

Document or Iniciative

Green Paper of 26 July 2000 – Environmental issues of PVC [COM(2000) 469 – Not published in the Official Journal].

Summary

A report on the PVC situation in Europe. Opinions vary on the effects of PVC on human health and the environment, as do the measures taken by some Member States to deal with the problem. PVC is one of today’s most widely used plastics. The European Commission therefore considers that an integrated approach is necessary. This would enable two objectives to be achieved: the proper functioning of the internal market and a high level of protection for human health and the environment.

The Green Paper follows on from the Commission’s commitment, in its draft Directive on end-of-life vehicles, to assess the impact of PVC waste on the environment in an “integrated approach”, i.e. throughout the life cycle of PVC. It is the outcome of a three-year study programme launched by the Commission on the technical, scientific and economic aspects of the PVC life cycle. The adoption of the Green Paper is an important milestone in the development of a global Community strategy on PVC.

The Green Paper tackles two main issues:

  • environmental and health questions concerning the use of certain additives in PVC (particularly lead, cadmium and phtalates);
  • the question of waste management (landfill, incineration, recycling of PVC waste): PVC waste is expected to increase by about 80% over the next twenty years.

The Green Paper also presents a range of policy options for reducing the impact on human health and the environment and for possible measures to form part of a future Community strategy on PVC.

The Commission wishes to organise the broadest possible consultation on the topics dealt with in the Green Paper, involving the general public, environmental and consumer NGOs, producers, processors and users of PVC, and the public authorities of the Member States. A public hearing was held in October 2000. On the basis of the consultation, the Commission will present a communication on the Community strategy on PVC.

Comments by interested parties were collected by the Commission until November 2000.

Related Acts

Commission Communication of 21 December 2005 – Taking sustainable use of resources forward: a Thematic Strategy on the prevention and recycling of waste [– Not published in the Official Journal].
This strategy sets out guidelines and describes measures aimed at reducing the pressure on the environment caused by waste production and management. The main thrust of the strategy is on amending the legislation to improve implementation, and on preventing waste and promoting effective recycling.

of the European Parliament and of the Council of 3 December 2001 on general product safety [Official Journal L 11 of 15 January 2002].
The general safety of products placed on the market is guaranteed by Community legislation, which ensures a consistent, high level of protection for the health and safety of consumers. The European Union (EU) has introduced a rapid alert system for products which pose a serious risk (RAPEX), and provisions for products to be withdrawn from the market if they are likely to put the health and safety of consumers at risk.

of the Commission of 7 December 1999 adopting measures prohibiting the placing on the market of toys and childcare articles intended to be placed in the mouth by children under three years of age, made of soft PVC containing one or more substances containing phthalates.
Toys intended to be placed in the mouth by children under three years of age and containing phthalates are prohibited throughout the European Union. Importing these products is also prohibited. Phthalates are toxic substances which may be found in soft PVC, a type of plastic which is also used in the manufacturing of toys.

Parliament resolution on the Commission’s Green Paper on Environmental Issues of PVC.
In this Resolution, Parliament criticises the Commission for failing to carry out an analysis of the life cycle of PVC products in order to make a comparison with alternative materials. Parliament calls on the Commission to present at the earliest opportunity a draft long-term horizontal strategy for the replacement of PVC. It proposes that the polluter pays principle be applied to PVC waste. It also calls for the necessary measures be taken to ensure the separate collection of PVC. Parliament calls on the Commission to propose banning the use of lead and cadmium in PVC. It suggests introducing a recycling system similar to that for junk automobiles and the compulsory labelling of all plastics.

Exposure to environmental tobacco smoke

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Exposure to environmental tobacco smoke

Outline of the Community (European Union) legislation about Exposure to environmental tobacco smoke

Topics

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

Public health > Health determinants: lifestyle

Exposure to environmental tobacco smoke (Proposal)

Proposal

Proposal for a Council Recommendation of 30 June 2009 on smoke-free environments [COM(2009) 328 final – Not published in the Official Journal].

Summary

This Proposal sets out the measures to be taken with a view to implementing Article 8 of the WHO Framework Convention on Tobacco Control (pdf ). Ratified by 26 EU Member States, the Article requires signatories to provide effective protection from exposure to tobacco smoke in:

  • indoor workplaces;
  • indoor public places;
  • public transport.

Targeting priority groups

Children and adolescents should be protected as a priority. To this end, Member States should establish or reinforce strategies to reduce the exposure of this high-risk group to second-hand tobacco smoke.

Complementing smoke-free policies

Smoke-free policies should be complemented by supporting measures such as measures relating to cessation of tobacco use or treatment for tobacco dependence.

Other supporting measures may be introduced in the area of information, such as the use on tobacco packages of photographs and warnings about associated health risks. Other information may also appear, such as the contact details of services supporting the cessation of tobacco use.

Developing a targeted strategy

Existing tobacco control strategies, programmes and plans should be reviewed and monitored regularly in order to protect the population from tobacco smoke in public and private settings. These strategies, programmes or plans should be supported by implementing tools.

National focal points should be established within six months after the adoption of the Recommendation, to promote the exchange of information and best practices between Member States.

Member States are strongly encouraged to work together to establish joint definitions, criteria and applications in order to pursue a coherent strategy throughout the Community.

Background

In 2007 the European Commission initiated consultation within the framework of the Green Paper “Towards a Europe free from tobacco smoke“. That consultation revealed that the majority of Member States favoured comprehensive smoke-free policies in all enclosed workplaces and public places. This position is explained in part by the figures on the effects of ETS on health. In 2008, 6000 people died in the EU following exposure to ETS, including 2500 non-smokers. Exposure to ETS also generates high economic costs which could be avoided.

REFERENCES AND PROCEDURE

Proposal Official Journal Procedure

COM(2009) 328 final

–

2009/0088/CNS

Food and feed safety

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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].

Multi-annual programme of action for health

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Multi-annual programme of action for health

Outline of the Community (European Union) legislation about Multi-annual programme of action for health

Topics

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

Public health > European health strategy

Multi-annual programme of action for health (2014-2020) (Proposal)

Proposal

Proposal for a Regulation of the European Parliament and of the Council of 9 November 2011 on establishing a Health for Growth Programme, the third multi-annual programme of EU action in the field of health for the period 2014-2020 [COM(2011) 709 final – Not published in the Official Journal].

Summary

The Health for Growth Programme (2014-2020) is the third multi-annual programme of European Union (EU) action. It helps/supports Member States in order to:

  • undertake the necessary reforms to achieve innovative and sustainable health systems;
  • improve access to better and safer health care for citizens;
  • promote good health of European citizens and prevent diseases;
  • protect European citizens from cross-border threats.

Objective No 1: Contributing to innovative and sustainable health systems

The European Commission must help Member States to address shortages of human and financial resources. It must also promote the implementation of innovation in health care, for example e-Health, and the sharing of expertise in this field. The Programme also supports the European Innovation Partnership on Active and Healthy Ageing.

Objective No 2: Increasing access to better and safer healthcare for citizens

The Commission suggests setting up the accreditation of European Reference Networks. This would allow, for example, action to be supported in the field of rare diseases. European guidelines should also be developed on patient safety and the use of antimicrobials.

Objective No 3: Promoting good health and preventing diseases

Member States are invited to exchange best practices on smoking prevention, abuse of alcohol and obesity. Specific action should also help to prevent chronic diseases, including cancer.

Objective No 4: Protecting citizens from cross border health threats

The Commission considers that the level of preparedness and response for serious cross border health threats must be improved.

Financial provisions

The financial allocation for the Programme is EUR 446 million for the period from 1 January 2014 to 31 December 2020. The following may participate in the Programme:

  • all EU Member States;
  • countries acceding to the EU, candidate countries and potential candidates benefiting from a pre-accession strategy;
  • European Free Trade Association (EFTA) countries in accordance with the conditions established in the European Economic Area (EEA) Agreement;
  • neighbouring countries and countries to which the European Neighbourhood Policy (ENP) applies in accordance with the conditions established in bilateral or multilateral agreements.

The EU may also make financial contributions in the form of grants or public procurement to fund actions having European added value, or grants for the functioning of non-governmental bodies. Such grants contribute 60 % of eligible costs and cover a wide spectrum of legally established organisations such as:

  • public authorities and public sector bodies;
  • research institutions;
  • health institutions;
  • universities;
  • higher education establishments;
  • undertakings.

In exceptional cases only, these grants may be up to 80 % of eligible costs.

Funding may also cover expenditure on preparatory, monitoring, control, audit and evaluation activities required for the implementation of the Programme.

Implementation of the Programme

Implementation of Programme actions shall be monitored by the Commission, in close collaboration with Member States. The Commission shall, furthermore, be assisted by a committee pursuant to the Regulation on the Commission’s exercise of implementing powers.

Member States shall designate National Focal Points in order to disseminate the Programme and its results in their countries.

This Regulation repeals the Decision on the Second programme of Community action in the field of health from 1 January 2014.

Reference

Proposal Official Journal Procedure

COM(2011) 709 final

–

2011/0339/COD

Release of N-nitrosamines from rubber teats

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Release of N-nitrosamines from rubber teats

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

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

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.

Summary

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.

REFERENCES

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

24.3.1993

1.4.1994

OJ L 93 of 17.4.1993

Exposure to asbestos

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Exposure to asbestos

Outline of the Community (European Union) legislation about Exposure to asbestos

Topics

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

Employment and social policy > Health hygiene and safety at work

Exposure to asbestos

Asbestos is a dangerous product which can cause serious diseases. The exposure of workers to this product is monitored and harmonised at European level. The different degrees of exposure are adjusted in line with the development of scientific knowledge on the subject.

Document or Iniciative

Council Directive 83/477/EEC of 19 September 1983 on the protection of workers from the risks related to exposure to asbestos at work (second individual Directive within the meaning of Article 8 of Directive 80/1107/EEC) [See amending acts].

Summary

Directive 83/477/EEC and Directive 91/382/EEC

The Directives do not apply to sea or air transport.

“Asbestos” is taken to mean six fibrous silicates (actinolite, asbestos gruenerite, anthophyllite, chrysotile, crocidolite, and tremolite). The limit values pertaining to in-air concentrations are:

  • for chrysotile: 0.60 fibres per cm3 calculated or measured for an eight-hour reference period;
  • for all other forms of asbestos: 0.30 fibres per cm3 calculated or measured for an eight-hour reference period.

Any activity likely to entail risk of exposure to dust arising from asbestos or materials containing asbestos must be assessed in such a way as to determine the degree and nature of the workers’ exposure.

These activities are to be notified by the employer to the responsible authority of the Member State. The notification must include at least a description of the types and quantities of asbestos used, the activities and processes involved, and the products manufactured. Workers or their representatives are entitled to see the documents concerned.

The application of asbestos by means of the spraying process and working procedures that involve the use of low-density (less than 1g/cm3) insulating or soundproofing materials are prohibited.

Exposure to asbestos is reduced by limiting its use as far as possible, keeping to a minimum the number of persons exposed, and taking adequate measures to maintain buildings and ensure that materials are properly stored, transported and labelled.

In order to ensure compliance with the limit values, asbestos-in-air concentrations are to be measured regularly.

If these values are exceeded, the reasons must be identified and appropriate measures to remedy the situation must be taken before work is resumed.

The places in which activities giving rise to exposure risks are carried out must be clearly marked and indicated by warning signs. They are to be out of bounds to smokers and workers other than those who, by reason of work or duties, are required to enter such areas. Areas are to be set aside where workers can eat and drink without risking being contaminated by asbestos dust. Workers are to be provided with appropriate working or protective clothing.

Workers and/or their representatives must receive adequate information on health risks; the existence of limit values; the need for monitoring of the atmosphere; hygiene requirements and specific precautions to be taken.

Each worker’s state of health must be assessed, including a specific chest examination, prior to exposure to dust arising from asbestos or materials containing asbestos and subsequently at least once every three years for the duration of the exposure. The employer is required to keep a register indicating the nature and duration of the activity and the exposure to which the worker is subjected; both the worker concerned and doctors must have access to the information in the register.

A plan of work setting out the necessary health and safety measures is to be drawn up before the commencement of any demolition work or work involving removal of asbestos.

Member States must keep a register of cases of asbestosis and mesothelioma.

The employer will not be required to notify the authority, take atmospheric measurements, put up warning signs, carry out health assessment or inform workers if the assessment of the exposure risks shows that the asbestos-in-air concentration is as follows:

  • for chrysotile, lower than 0.20 fibres per cm3 for an eight-hour reference period or lower than a cumulative dose of 12.00 fibres over a three-month period,
  • for all other forms of asbestos, lower than 0.10 fibres per cm3 for an eight-hour reference period or lower than a cumulative dose of 6.00 fibres over a three-month period.

Directive 98/24/EC

Adapts the provisions of the above-mentioned Directives to Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers in the workplace. This Directive now applies to the exposure of workers to chemical agents

Directive 2003/18/EC

  • reduces the limit value for occupational exposure of workers to asbestos. It repeals the two limit values established by Directive 83/477, setting a single maximum limit value for airborne concentration of asbestos of 0.1 fibres per cm3 as an eight-hour time-weighted average (TWA);
  • abolishes the derogations applicable to the sea and air transport sectors;
  • prohibits activities exposing workers to asbestos fibres, with the exception of the treatment and disposal of products resulting from demolition and asbestos removal;
  • updates the practical recommendations on the clinical surveillance of exposed workers in the light of the latest medical expertise, with a view to the early detection of pathologies linked to asbestos.

References

Act Date of entry into force Deadline for transposition in the Member States Official Journal
Directive 83/477/EEC

22.9.1983

1.1.1987

1.1.1990 in the case of asbestos-mining activities

OJ L 263 of 24.9.1983
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Directive 91/382/EEC

4.7.1991

1.1.1993

1.1.1996 in the case of asbestos-mining activities

1.1.1999 for Greece

OJ L 206 of 29.7.1991
Directive 98/24/EC

25.5.1998

5.5.2001

OJ L 131 of 5.5.1998
Directive 2003/18/EC

15.4.2003

14.4.2006

OJ L 97 of 15.4.2003
Directive 2007/30/EC

28.6.2007

31.12.2007

OJ L 165 of 27.6.2007

Related Acts

Directive 2009/148/EC of the European Parliament and of the Council of 30 November 2009 on the protection of workers from the risks related to exposure to asbestos at work (Text with EEA relevance).

Directive of the European Parliament and of the Council of 20 June 2007 amending Council Directive 89/391/EEC, its individual Directives and Council Directives 83/477/EEC, 91/383/EEC, 92/29/EEC and 94/33/EC with a view to simplifying and rationalising the reports on practical implementation (Text with EEA relevance)
Member States must present a report every five years on the application of the Directive. The first report must cover the period from 2007 to 2012.

Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) [OJ L 158 of 30.04.2004; corrigendum OJ L 229 of 29.06.2004].
This Directive applies to asbestos. It includes provisions which are more favourable to health and safety in the workplace than those set out in Directive 83/477/EEC.

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).

 

Another Normative about Exposure to asbestos

Topics

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

Internal market > Single Market for Goods > Construction

Exposure to asbestos

Asbestos is a dangerous product which can cause serious diseases. The exposure of workers to this product is monitored and harmonised at European level. The different degrees of exposure are adjusted in line with the development of scientific knowledge on the subject.

Document or Iniciative

Council Directive 83/477/EEC of 19 September 1983 on the protection of workers from the risks related to exposure to asbestos at work (second individual Directive within the meaning of Article 8 of Directive 80/1107/EEC) [See amending acts].

Summary

Directive 83/477/EEC and Directive 91/382/EEC

The Directives do not apply to sea or air transport.

“Asbestos” is taken to mean six fibrous silicates (actinolite, asbestos gruenerite, anthophyllite, chrysotile, crocidolite, and tremolite). The limit values pertaining to in-air concentrations are:

  • for chrysotile: 0.60 fibres per cm3 calculated or measured for an eight-hour reference period;
  • for all other forms of asbestos: 0.30 fibres per cm3 calculated or measured for an eight-hour reference period.

Any activity likely to entail risk of exposure to dust arising from asbestos or materials containing asbestos must be assessed in such a way as to determine the degree and nature of the workers’ exposure.

These activities are to be notified by the employer to the responsible authority of the Member State. The notification must include at least a description of the types and quantities of asbestos used, the activities and processes involved, and the products manufactured. Workers or their representatives are entitled to see the documents concerned.

The application of asbestos by means of the spraying process and working procedures that involve the use of low-density (less than 1g/cm3) insulating or soundproofing materials are prohibited.

Exposure to asbestos is reduced by limiting its use as far as possible, keeping to a minimum the number of persons exposed, and taking adequate measures to maintain buildings and ensure that materials are properly stored, transported and labelled.

In order to ensure compliance with the limit values, asbestos-in-air concentrations are to be measured regularly.

If these values are exceeded, the reasons must be identified and appropriate measures to remedy the situation must be taken before work is resumed.

The places in which activities giving rise to exposure risks are carried out must be clearly marked and indicated by warning signs. They are to be out of bounds to smokers and workers other than those who, by reason of work or duties, are required to enter such areas. Areas are to be set aside where workers can eat and drink without risking being contaminated by asbestos dust. Workers are to be provided with appropriate working or protective clothing.

Workers and/or their representatives must receive adequate information on health risks; the existence of limit values; the need for monitoring of the atmosphere; hygiene requirements and specific precautions to be taken.

Each worker’s state of health must be assessed, including a specific chest examination, prior to exposure to dust arising from asbestos or materials containing asbestos and subsequently at least once every three years for the duration of the exposure. The employer is required to keep a register indicating the nature and duration of the activity and the exposure to which the worker is subjected; both the worker concerned and doctors must have access to the information in the register.

A plan of work setting out the necessary health and safety measures is to be drawn up before the commencement of any demolition work or work involving removal of asbestos.

Member States must keep a register of cases of asbestosis and mesothelioma.

The employer will not be required to notify the authority, take atmospheric measurements, put up warning signs, carry out health assessment or inform workers if the assessment of the exposure risks shows that the asbestos-in-air concentration is as follows:

  • for chrysotile, lower than 0.20 fibres per cm3 for an eight-hour reference period or lower than a cumulative dose of 12.00 fibres over a three-month period,
  • for all other forms of asbestos, lower than 0.10 fibres per cm3 for an eight-hour reference period or lower than a cumulative dose of 6.00 fibres over a three-month period.

Directive 98/24/EC

Adapts the provisions of the above-mentioned Directives to Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers in the workplace. This Directive now applies to the exposure of workers to chemical agents

Directive 2003/18/EC

  • reduces the limit value for occupational exposure of workers to asbestos. It repeals the two limit values established by Directive 83/477, setting a single maximum limit value for airborne concentration of asbestos of 0.1 fibres per cm3 as an eight-hour time-weighted average (TWA);
  • abolishes the derogations applicable to the sea and air transport sectors;
  • prohibits activities exposing workers to asbestos fibres, with the exception of the treatment and disposal of products resulting from demolition and asbestos removal;
  • updates the practical recommendations on the clinical surveillance of exposed workers in the light of the latest medical expertise, with a view to the early detection of pathologies linked to asbestos.

References

Act Date of entry into force Deadline for transposition in the Member States Official Journal
Directive 83/477/EEC

22.9.1983

1.1.1987

1.1.1990 in the case of asbestos-mining activities

OJ L 263 of 24.9.1983

Amending act(s) 		Entry into force Deadline for transposition in the Member States Official Journal
Directive 91/382/EEC

4.7.1991

1.1.1993

1.1.1996 in the case of asbestos-mining activities

1.1.1999 for Greece

OJ L 206 of 29.7.1991
Directive 98/24/EC

25.5.1998

5.5.2001

OJ L 131 of 5.5.1998
Directive 2003/18/EC

15.4.2003

14.4.2006

OJ L 97 of 15.4.2003
Directive 2007/30/EC

28.6.2007

31.12.2007

OJ L 165 of 27.6.2007

Related Acts

Directive 2009/148/EC of the European Parliament and of the Council of 30 November 2009 on the protection of workers from the risks related to exposure to asbestos at work (Text with EEA relevance).

Directive

2007/30/EC

of the European Parliament and of the Council of 20 June 2007 amending Council Directive 89/391/EEC, its individual Directives and Council Directives 83/477/EEC, 91/383/EEC, 92/29/EEC and 94/33/EC with a view to simplifying and rationalising the reports on practical implementation (Text with EEA relevance)
Member States must present a report every five years on the application of the Directive. The first report must cover the period from 2007 to 2012.

Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) [OJ L 158 of 30.04.2004; corrigendum OJ L 229 of 29.06.2004].
This Directive applies to asbestos. It includes provisions which are more favourable to health and safety in the workplace than those set out in Directive 83/477/EEC.


Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).

 

Response to natural or man-made disasters

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Response to natural or man-made disasters

Outline of the Community (European Union) legislation about Response to natural or man-made disasters

Topics

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

Environment > Civil protection

Response to natural or man-made disasters

Document or Iniciative

Communication from the Commission to the European Parliament and the Council of 5 March 2008 on “Reinforcing the Union’s Disaster Response Capacity” [COM(2008) 130 final – Not published in the Official Journal].

Summary

The Commission has put forward proposals which aim to reinforce the European Union’s

disaster response capacity. The notion of ‘disaster’ is used in a broad sense to cover natural or man-made disasters and conflict-related emergencies taking place within the European Union (EU) and also outside its borders.

In order to react effectively to these disasters, a comprehensive approach including risk assessment, forecast, prevention, preparedness and rehabilitation is required. This also requires the mobilisation of all the policies, instruments and services available to the Community and Member States.

Planning, coordination and rapid response

The Commission stresses the need to reinforce the links between civil protection and the environmental policies included in environmental legislation in order to take full advantage of the preventive measures included in the latter. Importance is also placed on developing synergies with international, national and local stakeholders to achieve better coordination.

In particular, the Commission put forward the suggestion to streamline coordination between itself, the Council and Member States for large scale disasters involving both Community instruments and Common Foreign and Security Policy (CFSP) instruments. The Commission referred to the opportunity to establish joint planning and operational teams as well as to develop standard operational procedures adapted to different types of disasters and geographical areas.

The Commission reiterated that it manages many Rapid Alert Systems (RAS) in case of specific sectoral disasters. It also decides on Community humanitarian assistance and coordinates the Community Civil Protection Mechanism. Furthermore, the Commission has at its disposal a number of instruments it can use to finance disaster prevention measures or to alleviate the financial costs incurred by public authorities when undertaking emergency operations. These instruments include the European Regional Development Fund (ERDF), the European Union Solidarity Fund (EUSF), funds allocated for Rural Development, the Civil Protection Financial Instrument (CPFI) and the Instrument for Stability.

The Commission also has at its disposal a number of coordination tools for managing crisis situations more effectively, such as ARGUS, an internal mechanism developed in June 2006 to respond to multidimensional crises, and the RELEX Crisis Platform, established after the 2004 Tsunami, which assists political coordination between the Commission and Member States during external crisis situations.

Improving humanitarian aid

The Commission aims to improve the European Union’s humanitarian aid capacities. In particular this will be achieved by identifying existing gaps in terms of logistics, further strengthening the rapid assessment and response capacity in the field and improving liaison between the different actors involved.

Noting that the majority of disasters taking place in third countries do not trigger an international response and that when an international response is initiated, it often takes days for external assistance to reach the site, the Commission believes it is important to have an active expert presence in the field and to ensure that local authorities have the capacity to react immediately.

Reinforcing civil protection

In the field of civil protection, the Commission proposes to build up the Monitoring and Information Centre so that it can take on the role of the European Union’s operational centre for intervention. It also aims to improve the European Union’s response capacity, whilst keeping in reserve the means to rapidly intervene in the event of a disaster.

The Commission intends to undertake studies and finance diverse projects with the aim of developing a knowledge base on the EU’s capacity to intervene quickly in the event of major disasters in a Member State or third country. This will include studies on scenarios which aim to identify potential shortcomings and trial runs of different methods which would enable rapid intervention capacities to be kept in reserve. On this basis the Commission will put forward appropriate proposals.

The Commission suggests undertaking other measures in parallel, such as the creation of a European Disaster Response Training Network, the development of early warning systems and promoting the use of the single European emergency number (“112”).

The Communication includes an Annex on the subject of forest fires to clearly demonstrate how further prevention, preparedness, response and recovery measures could be combined to deal with such a disaster in a more effective manner.

Context

The increase in major disasters in recent years (the 2004 tsunami in Asia, the war in Lebanon in 2006, forest fires and floods in Europe in 2007) and the risk of increasingly frequent disasters due to climate change makes modernisation and adaptation of the European Union’s means of response essential.

In December 2007 the European Parliament and European Council invited the Council and Commission to make the best use of the Community Civil Protection Mechanism and the Civil Protection Financial Instrument to help prepare for major emergencies. Furthermore, in December 2007 the European Parliament and the European Council signed the European Consensus on Humanitarian Aid, a comprehensive framework for improved delivery of humanitarian aid at the European Union level.

Moreover, the Commission believes that a disaster management policy must include measures aimed at preventing this type of event. The Commission announced its intention to present an integrated approach to disaster prevention in the European Union, as well as a European Strategy for Disaster Risk Reduction in Developing Countries.