Tag Archives: Health

Sectoral development policies

Sectoral development policies

Outline of the Community (European Union) legislation about Sectoral development policies

Topics

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

Development > Sectoral development policies

Sectoral development policies

Within the framework of development cooperation the Union places the emphasis on a number of areas where solutions have been tailored to the needs of developing countries on the basis of the relevant comparative advantage, which involve not only economic and social development and governance but also the environment food security, agriculture and infrastructure.

This thematic, cross-sectoral approach, particularly highlighted in the “European Consensus on Development”, also aims to ensure cohesion between European policies and the development priorities which might be affected by those policies.

GOVERNANCE, HUMAN RIGHTS, RULE OF LAW AND DEMOCRACY

Governance

  • Governance in the consensus on development
  • Governance and development
  • Tax governance in developing countries

Human Rights

  • A financing instrument for the promotion of democracy and human rights in the world (2007 – 2013)

Non-Governmental Organisations (NGO) and civil society

  • Local authorities and development assistance
  • Non-state Actors and Local Authorities
  • Cooperation with indigenous peoples

HUMAN AND SOCIAL DEVELOPMENT

Education and training

  • Investing in people
  • Education and training in the context of poverty reduction

Equality between men and women

  • Strategy for gender equality in development policy

Children

  • Children in EU external action

Health

  • The EU Role in Global Health
  • Health: health and poverty reduction
  • Programme for Action to combat lack of personnel in the health sector (2007-2013)
  • Compulsory licensing system for the production and export of generic medicinal products to developing countries
  • Programme for Action to Confront HIV/AIDS, Malaria and Tuberculosis (2007-2011)
  • Update on the EC Programme for Action – Accelerated action on HIV/AIDS, malaria and tuberculosis
  • Health: programme for accelerated action on HIV/AIDS, malaria and tuberculosis (2001-2006)
  • Essential medicines for developing countries (HIV/AIDS, tuberculosis and malaria)
  • Health: global fund to fight HIV/AIDS, tuberculosis and malaria

SUSTAINABLE DEVELOPMENT

  • Global partnership for sustainable development
  • Integrating sustainable development into Community cooperation policy
  • Strategy for sustainable development

ENVIRONMENT AND MANAGEMENT OF NATURAL RESOURCES

General

  • Environment and sustainable management of natural resources, including energy
  • United Nations Convention to combat desertification in countries seriously affected by drought

Climate change

  • Global climate change alliance
  • Climate change in the context of development cooperation

Biodiversity

  • Biodiversity Action Plan for Economic and Development Co-operation
  • The Rio de Janeiro Convention on biological diversity

Water

  • Water: water management in developing countries
  • Guidelines for cooperation towards development in the area of water resources
  • European Water Facility for the ACP countries

Energy

  • The Global Energy Efficiency and Renewable Energy Fund
  • Cooperation with Non-EU Member Countries on nuclear safety
  • Energy cooperation with the developing countries
  • ACP-EU Energy Facility

Forests

  • FLEGT Licensing scheme
  • Fight against illegal logging
  • Combating deforestation

Fisheries

  • Partnership agreements with Non-EU Member Countries
  • Fisheries: fisheries and poverty reduction

AGRICULTURE AND RURAL DEVELOPMENT

  • Agricultural commodities, dependence and poverty
  • Fighting rural poverty
  • Advancing African agriculture
  • Land policy in developing countries
  • Partnership with Africa for the development of the cotton industry
  • The International Coffee Agreement 2007

FOOD SECURITY

  • Strategic framework for food security in developing countries
  • Facility for rapid response to soaring food prices
  • Combating hunger: strategy for food security
  • Food Aid Convention

ECONOMIC AND COMMERCIAL DEVELOPMENT

  • Supporting developing countries in coping with the crisis

Trade

  • Scheme of preferences from 2006 to 2015 – Guidelines
  • A scheme of generalised tariff preferences 2009-2011
  • Generalised System of Preferences 2006 – 2008
  • Aid for Trade in developing countries
  • Towards an EU Aid for Trade strategy
  • Assisting developing countries to benefit from trade
  • Fair Trade and non-governmental trade-related sustainability assurance schemes
  • Fair trade

Businesses

  • International investments: towards a comprehensive European policy
  • EU support for business sector development in third countries
  • The reform of state-owned enterprises in developing countries

INFRASTRUCTURE

  • Euro-African Partnership for infrastructure

Transport

  • Transport: guidelines
  • Promoting sustainable transport

Communication and information

  • Information and communication Technologies

Tourism

  • Development of sustainable tourism

MIGRATION

  • Migration and development: some concrete orientations
  • Cooperation with Non-EU Member Countries in the areas of migration and asylum

OTHER SECTORAL PROVISIONS

  • Mine Action Strategy 2005-2007

A call for action to strengthen the European-based pharmaceutical industry for the benefit of the patient

A call for action to strengthen the European-based pharmaceutical industry for the benefit of the patient

Outline of the Community (European Union) legislation about A call for action to strengthen the European-based pharmaceutical industry for the benefit of the patient

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

A call for action to strengthen the European-based pharmaceutical industry for the benefit of the patient

Document or Iniciative

Communication from the Commission of 1 July 2003 on strengthening the European pharmaceutical industry for the benefit of the patient. [COM(2003) 383 final – Not published in the Official Journal].

Summary

BACKGROUND

The “G10 Medicines Group” was set up in 2001 on the initiative of the Members of the European Commission responsible for the “Enterprise” and “Health and Consumer Protection” Directorates-General. Alongside the two Commission representatives, it is made up of ten experts recruited from the industry, national Ministries of Health, social security organisations and patients groups.

This focus group was asked to recommend ways of improving the performance of the pharmaceutical industry in terms of its competitiveness and its contribution to social and public health objectives.

In accordance with the objectives it was set, the G10 group submitted its final report to the Commission in May 2002.

This contains a set of 14 recommendations prompted by two considerations:

  • the pharmaceutical industry in Europe generates wealth and high quality employment whilst playing a central role in the development of innovation. It can thus make a major contribution to achieving the goals set in Lisbon (a competitive knowledge-based economy, sustainable economic growth, and more and better jobs);
  • the pharmaceutical sector is lagging behind the USA in its ability to generate, organise and sustain innovative processes. In addition, European markets are not competitive enough and R&D expenditure is not growing fast enough.

Faced with this situation, the G10 group pointed out that tackling the growing weaknesses in the EU pharmaceutical industry is both a major industrial policy concern and a key public health objective (to improve the quality, safety and efficacy of medicines for the benefit of the public).

In this communication, the Commission states how it wishes to implement these recommendations and proposes certain actions the Member States could take on matters of national competence.

WORKING FOR THE BENEFIT OF THE PATIENT

Improving patient information

With the steady growth in the demand and use of health information by patients, the information sources on offer (particularly on the Internet) are proliferating. Faced with this new situation, the Commission seeks to improve the quality and reliability of this information and provide a realistic and practical framework to give patients access to objective data.
Following on from its communication in 2002 entitled “Quality criteria for health-related websites”, the Commission proposes looking into the possible development of European seals of approval for such sites.
In addition, as part of the new Public Health Programme (2003-2008), a European Health Portal is being developed which should allow this information to be disseminated to the general public.

To increase public confidence in the information on medicines, the Commission will reflect on establishing a collaborative Public Private Partnership involving representatives from public authorities, industry, health funds, healthcare professionals and patient groups. This partnership could take the form of a small body that would be able to advise and monitor the quality of the information already available. It would also produce guidelines in specific areas to support the work of National and Community regulatory authorities.

Finally, the Commission would like to ensure that patients consume medicines appropriately. To do so, it wishes to ensure that the information contained in the patient information leaflet and on the label (dosage, contra-indications, special precautions for use) are as comprehensible and legible as possible.

Strengthening the role of patients in public-health decision-making

Also under the Public Health Programme (2003-2008), the Commission plans to make funds available to patient groups looking to create a Community umbrella organisation. The Commission would also like these groups to assume a more important role in the development of Community health and medicines policy.

The concept of the relative effectiveness of medicines

The Commission wants to set up a forum where Member States which use relative effectiveness measures to set prices and reimbursement levels for medicines could exchange information on their methods. This would make it possible to analyse whether, on the basis of the national approaches used to calculate the relative effectiveness of a medicine, i.e. the assessment of added therapeutic value (its clinical effectiveness compared to other treatments) and its cost effectiveness, an effective and faster common procedure could be introduced.

Improving pharmacovigilance systems

The Commission wishes to strengthen pharmacovigilance at Community level through the role of the European Medicines Agency (EMEA) which should help coordinate national action and centralise results. The ultimate aim is to enable Member States to benefit from more information about adverse reactions to the use by the general population of a medicine which has previously only been tested during clinical trials.

DEVELOPING THE INDUSTRY’S COMPETITIVENESS

Updating the regulatory structure

In order to improve marketing authorisation procedures, the Commission points out that it would be desirable to shorten dossier assessment times and make greater use, under the centralised procedure, of telematics through EudraNET, the EuroPHARM Database and EudraVigilance.

Access to innovative medicines

The development of innovative medicines with a high added therapeutic value should be encouraged under the 6th Framework Programme for Research.

In addition the Commission, through its proposal for a review of pharmaceutical legislation, has demonstrated its desire to support research into innovative medicines and provide sufficient protection for the exclusivity of the data on such medicines.

The timing of reimbursement and pricing negotiations

The Member States should examine their existing pricing and reimbursement systems to ensure that they operate fully in accordance with the transparency requirements and within the timeframe set by Directive 89/105/EEC (pricing of medicinal products and health insurance systems).

The Commission and Member States should examine the scope for reducing the time taken between granting a marketing authorisation and pricing and reimbursement decisions to the absolute minimum.

For the time being, the prices of medicines are widely divergent amongst Member States as they are set by national administrative decisions. To facilitate market integration, the Commission suggests giving manufacturers the possibility of setting the prices of medicinal products, while negotiating with the Member States the possibility of introducing safeguard mechanisms to contain pharmaceutical expenditure by the State. Such a system is intended to open the way for the free fixing of prices of medicines on the market, as with any other product in the internal market.

Medicines not reimbursed by the State

The Commission asks the Member States to remove price controls on manufacturers that prevent full competition for medicines that are not reimbursed by the State and for those which are not to be sold to the public sector.

The competitive generic medicines market

Generic medicines can provide significant savings to patients and to national healthcare financing systems, which is why the Commission stresses the need to facilitate generic penetration in the different national markets.

In order to put this into effect, the Commission points out that generic producers should be given the opportunity to supply generic medicines to Member States where the reference product is not on their market.

This communication also points out that, as part of the reform of the Community code relating to medicinal products for human use, the Council’s common position suggests the possibility of introducing a marketing authorisation application for a generic and to grant this authorisation in the last two years of the data protection period of the reference product for all products except those falling within the mandatory scope of the centralised procedure. This will allow these products to come onto the market immediately after the end of the ten-year data protection period.

The competitive non-prescription market

To reduce the differences amongst Member States in products classified as non-prescription, the Commission suggests that there be greater consistency in classification decisions.

Moreover, since the reclassification of medicines from prescription to non-prescription status brings benefits to patients, healthcare professionals, governments, healthcare systems and industry alike, the Commission suggests the introduction of a period of data exclusivity where significant clinical or pre-clinical data have been submitted with the application.

Finally, the Commission advocates that the Member States allow the use of the same trademark after reclassification where there is no risk to public health, as this avoids financial costs which may dissuade producers from taking this step.

STRENGTHENING THE SCIENCE BASE

The fragmented nature of European research systems (lack of scientific collaboration among Member States and between the public and private sectors) is hampering R&D activity in the EU and the introduction of innovative processes.
The Commission suggests a very broad range of measures to remedy these problems:

  • taking forward the concept of European virtual institutes of health;
  • creating a genuine European research area as set out in the sixth framework programme for research (scientific cooperation and training to stem the loss of highly-skilled European scientists);
  • an increase in Community research spending to 3% of GDP in the EU by 2010 in line with the strategy agreed at the Barcelona European Council in March 2002;
  • the implementation of a life science and biotechnology action plan (skilled workforce, financial support, networking of biotechnology regions in Europe, developing the size of enterprises in the sector);
  • the creation of a European Centre for Disease Prevention and Control which should become operational no later than 2005;
  • the development of proposals to encourage R&D on diseases which are currently neglected or where R&D is lacking.

The incentives for research which the Commission wishes to introduce also include:

  • the creation of a database on clinical trials and the drafting of detailed guidelines on the principles of good clinical practice as defined in directive 2001/20/EC;
  • the promotion of research into orphan medicines by taking measures on rare diseases;
  • finalisation of the proposal for a regulation on medicines for paediatric use which is expected in 2004;
  • the rapid implementation by all Member States of the Directive on Legal Protection of Biological Inventions and the adoption of the Community patent legislation.

MEDICINES IN AN ENLARGED EUROPEAN UNION

The health status in the future Member States is generally lower than in the rest of the EU and they devote fewer resources to healthcare. Also, the levels of intellectual property protection differ, leading to divergences in price levels, which could cause an increase in parallel imports.

For a limited period after accession, some medicines on the market in the new Member States will not have the same level of intellectual property protection found in the existing Member States. The Accession Treaties were, therefore, amended to include a transitional period prior to the full application of the principle of free movement to prevent the parallel import of pharmaceutical products that lack equivalent intellectual property right protection.

In addition, under the pharmaceutical legislation review, there will be a statutory requirement for parallel importers to inform both the marketing authorisation holder and the competent authorities of their intention to proceed with a parallel import in a given Member State. However, the legal responsibility for enforcing intellectual property rights will remain with the patent holder.

The pharmaceutical legislation review will also allow generic supply of medicines in Member States where there is no reference product on the market, and help to alleviate problems of availability in the new Member States.

Alongside these different measures, the new Member States have been offered practical help to prepare for accession through the Pan European Regulatory Forum (PERF).

THE EXCHANGE OF INFORMATION AMONG MEMBER STATES

In its final report, the G10 Medicines Group recommends the development of a set of EU indicators to cover both industry competitiveness and public health objectives. Benchmarking is no solution to the problems of competitiveness in itself but it will, for the first time, establish a set of agreed EU performance indicators that will provide a comprehensive and objective basis for measuring the implementation of the recommendations and to exchange best practice.

The competitiveness indicators cover four broad areas: supply, demand and the regulatory framework, industry outputs, and macroeconomic factors. The Commission will publish annual tables of competitiveness indicators. This data will thus provide a basis for discussion in the Council, the European Parliament and at International Conferences.

Developing a set of indicators that can monitor the role of the pharmaceutical industry in preventing and treating disease is no easy task. While industry has clearly made a key contribution to public health in a number of areas, it is difficult to quantify in global terms and in terms of individual products or for specific diseases. The Commission is working on the development of a range of indicators in this field which should cover:

  • the availability of pharmaceutical products, compared to other health care inputs, for priority diseases;
  • the significance of available medicines, e.g. in terms of their effectiveness;
  • the identification of those diseases for which there are no effective medicines;
  • the prescription and rational use, at the medical professional and patient level;
  • patient quality issues such as the acceptability of medicines.

FOLLOW-UP MEASURES

Benchmarking follow-up

The Commission undertakes to update and adapt these performance indicators annually and to submit them to the Council and the European Parliament at regular intervals. It also plans to set up a small secretariat to take forward the benchmarking exercise.

Maintaining the momentum of G10

The Commission would like Member States, on a voluntary basis, to communicate national measures that could have an impact on G10 Medicines-related issues.

The Commission invites the Council and the European Parliament, together with other stakeholders, to take forward the key actions highlighted in this Communication

The Commission will support the organisation of annual meetings to follow up this Communication and to verify progress on key actions.

 

Cosmetic products

Cosmetic products

Outline of the Community (European Union) legislation about Cosmetic 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 welfare

Cosmetic products (from 2013)

Document or Iniciative

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (Text with EEA relevance).

Summary

Cosmetic products are substances * or mixtures of substances intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, etc.) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

Free movement of these products in the internal market is permitted if they comply with this Regulation.

Market surveillance

A responsible person established in the Community shall be designated for each product placed on the market. This person shall ensure compliance of the products with the rules set out in the Regulation. In particular, they shall ensure compliance with requirements relating to human health, safety and consumer information. They shall maintain a product information file accessible to the public authorities.

In order to ensure product traceability, responsible persons shall identify the distributors to whom they supply the cosmetic product: for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor. The same applies to all other persons involved in the supply chain.

In case of product non-compliance, the responsible person shall take measures to render it compliant, withdraw it from the market or recall it to the manufacturing company in all Member States where the product is available. Where the responsible person does not take all appropriate measures, the competent national authorities may take the necessary corrective measures.

If a product which complies with the requirements of the Regulation presents or could present a serious risk to human health, the competent national authority shall take all necessary provisional measures to withdraw, recall or restrict the availability of the product on the market.

Limitations for certain substances

The Annexes of this Regulation give a list of prohibited substances (Annex II) or restricted substances (Annex III) with respect to use in cosmetic products. Certain colorants (other than those in Annex IV), preservatives (other than those in Annex V) and UV-filters (other than those in Annex VI) are also prohibited.

The Regulation prohibits the use of substances recognised as carcinogenic, mutagenic or toxic for reproduction (classified as CMR), apart from in exceptional cases. It provides for a high level of protection of human health where nanomaterials are used in cosmetic products.

Consumer information

Product labelling contributes to consumer protection. Containers or packaging must bear written information in indelible, easily legible and visible lettering. This information concerns:

  • the name or registered name and the address of the responsible person;
  • the country of origin for imported products;
  • the weight or volume of the content at the time of packaging;
  • a use-by date for products kept in appropriate conditions;
  • precautions for use, including for cosmetics for professional use;
  • the batch number of manufacture or the reference for identifying the cosmetic product;
  • the list of ingredients, i.e. any substance or mixture intentionally used in the product during the process of manufacturing.

The language of the information shall be determined by the Member State where the product is made available to the end user.

Animal testing

Animal testing must be replaced by alternative methods. The Regulation prohibits the performance of animal testing in the European Union for:

  • finished products,
  • ingredients or combinations of ingredients.

The Regulation also prohibits the placing on the European Union market of:

  • products where the final formulation has been the subject of animal testing;
  • products containing ingredients or combinations of ingredients which have been the subject of animal testing.

A derogation from the ban relating to placing products on the market shall be granted until 11 March 2013 in order to test repeated-dose toxicity, the effects of certain substances on reproduction and to study toxicokinetics *.

In exceptional circumstances, Member States may request the Commission to grant a derogation, after consulting the Scientific Committee for Consumer Safety (SCCS), if an ingredient in wide use which cannot be replaced gives rise to serious concerns.

Committee procedure

The Commission shall be assisted by the Standing Committee on Cosmetic Products.

Context

This Regulation recasts Directive 76/768/EEC due to the many amendments made to it and the new amendments that were required.

The new Regulation shall apply in 2013. However, some of its provisions will apply from 1 December 2010: they concern substances which are carcinogenic, mutagenic or toxic for reproduction (classified as CMR).

Key terms
  • Substance: a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
  • Toxicokinetics: study of the long-term effects of toxic substances in the body.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1223/2009

11.7.2013

1.12.10 (Articles 15 paragraphs 1 and 2, Articles 14, 16, 31 and 32)

11.1.2013 (Article 16, paragraph 3, second section)

OJ L 342 of 22.12.2009


Another Normative about Cosmetic 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 welfare

Cosmetic products (until 2013)

Document or Iniciative

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (Cosmetics Directive) [See amending act(s)].

Summary

The free movement of cosmetic products within the European market cannot be restricted or prohibited by Member States if these products are not dangerous to human health under normal or foreseeable conditions of use.

However, if a cosmetic product conforming to this Directive constitutes a danger to human health, the Member State of the territory on which the product is marketed may take restrictive or prohibitive measures. In this instance, it informs the other Member States and the Commission so that appropriate measures can be taken throughout the European Union (EU).

Ingredients and composition

The Directive determines the list of substances which are prohibited in the composition of cosmetic products (Annex II) and the substances which are subject to restrictions or specific conditions of use (Annex III).

The Directive also contains lists of authorised colourings (Annex IV), preservatives (Annex VI) and UV filters (Annex VII).

Labelling

Containers and/or packaging must specifically mention, in indelible, easily legible and visible characters:

  • the name and address of the manufacturer or of the person responsible for marketing the product;
  • the nominal contents at the time of packaging, by weight or by volume;
  • the date of minimum durability indicated for products with a minimum durability of less than 30 months;
  • the period of time after opening for which the product can be used for products with a minimum durability of more than 30 months (indicated with the symbol representing an open pot of cream);
  • the function of the product and particular precautions for use;
  • the batch number.

This information must be in the official language(s) of the respective Member State.

Moreover, the labelling must contain a list of ingredients. Perfume and aromatic compositions are designated by the words “perfume” or “aroma”, except where these have been identified as a significant cause of allergic reactions.

Market surveillance

Member States are responsible for monitoring their market. To this end, they check the safety of products manufactured or imported in the EU. Furthermore, they also ensure that the characteristics attributed to cosmetic products are not deceptive.

The manufacturer, the importer or the person responsible for marketing the product must inform the national competent authorities when a product is imported into the EU for the first time.

Animal testing

The Directive puts an end to animal testing by imposing bans on:

  • testing finished cosmetic products and ingredients on animals (testing ban);
  • marketing finished cosmetic products which have been tested on animals or which contain ingredients that have been tested on animals (marketing ban).

With regard to repeated-dose toxicity tests, reproductive toxicity tests, and toxicokinetics, the marketing prohibition applies from 11 March 2013. This prohibition is applicable regardless of the availability of alternative test methods.

Context

This Directive is replaced by Regulation (EC) No 1223/2009 from 11 July 2013.

References

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

Directive 76/768/EEC

30.7.1976

30.1.1978

OJ L 262 of 27.9.1976

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

Directive 79/661/EEC

26.7.1979

30.7.1979

OJ L 192 of 31.7.1979

Directive 82/368/EEC

19.5.1982

31.12.1983

OJ L 167 of 15.6.1982

Directive 83/574/EEC

4.11.1983

31.12.1984

OJ L 332 of 28.11.1983

Directive 88/667/EEC

14.1.1989

31.12.1989

OJ L 382 of 31.12.1988

Directive 89/679/EEC

3.1.1990

3.1.1990

OJ L 398 of 30.12.1989

Directive 93/35/EEC

23.6.1993

14.6.1995

OJ L 151 of 23.6.1993

Directive 2003/15/EC

11.3.2003

11.9.2004

OJ L 66 of 11.3.2003

Successive amendments and corrections to Directive 76/768/EEC have been incorporated in the basic text. This consolidated version  has a purely documentary value”.

Related Acts

Non-inclusion of ingredients on labelling

Commission Directive 95/17/ECof 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non- inclusion of one or more ingredients on the list used for the labelling of cosmetic products.

Inventory and common nomenclature of ingredients

Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products [Official Journal L 132 of 1.6.1996].

Checking the composition of cosmetic products

First Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 87/143/EEC, Official Journal L 57 of 27.2.1987].

Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the Laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 90/207/EEC, Official Journal L 108 of 28.4.1990].

Third Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 291 of 24.10.1983].

Fourth Commission Directive 85/490/EEC of 11 October 1985 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 295 of 7.11.1985].

Fifth Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking composition of cosmetic products [OJ L 231 of 14.9.1993].

Sixth Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 178 of 28.7.1995].

Seventh Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 213 of 22.8.1996].


Another Normative about Cosmetic products

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

Cosmetic products (until 2013)

Document or Iniciative

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (Cosmetics Directive) [See amending act(s)].

Summary

The free movement of cosmetic products within the European market cannot be restricted or prohibited by Member States if these products are not dangerous to human health under normal or foreseeable conditions of use.

However, if a cosmetic product conforming to this Directive constitutes a danger to human health, the Member State of the territory on which the product is marketed may take restrictive or prohibitive measures. In this instance, it informs the other Member States and the Commission so that appropriate measures can be taken throughout the European Union (EU).

Ingredients and composition

The Directive determines the list of substances which are prohibited in the composition of cosmetic products (Annex II) and the substances which are subject to restrictions or specific conditions of use (Annex III).

The Directive also contains lists of authorised colourings (Annex IV), preservatives (Annex VI) and UV filters (Annex VII).

Labelling

Containers and/or packaging must specifically mention, in indelible, easily legible and visible characters:

  • the name and address of the manufacturer or of the person responsible for marketing the product;
  • the nominal contents at the time of packaging, by weight or by volume;
  • the date of minimum durability indicated for products with a minimum durability of less than 30 months;
  • the period of time after opening for which the product can be used for products with a minimum durability of more than 30 months (indicated with the symbol representing an open pot of cream);
  • the function of the product and particular precautions for use;
  • the batch number.

This information must be in the official language(s) of the respective Member State.

Moreover, the labelling must contain a list of ingredients. Perfume and aromatic compositions are designated by the words “perfume” or “aroma”, except where these have been identified as a significant cause of allergic reactions.

Market surveillance

Member States are responsible for monitoring their market. To this end, they check the safety of products manufactured or imported in the EU. Furthermore, they also ensure that the characteristics attributed to cosmetic products are not deceptive.

The manufacturer, the importer or the person responsible for marketing the product must inform the national competent authorities when a product is imported into the EU for the first time.

Animal testing

The Directive puts an end to animal testing by imposing bans on:

  • testing finished cosmetic products and ingredients on animals (testing ban);
  • marketing finished cosmetic products which have been tested on animals or which contain ingredients that have been tested on animals (marketing ban).

With regard to repeated-dose toxicity tests, reproductive toxicity tests, and toxicokinetics, the marketing prohibition applies from 11 March 2013. This prohibition is applicable regardless of the availability of alternative test methods.

Context

This Directive is replaced by Regulation (EC) No 1223/2009 from 11 July 2013.

References

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

Directive 76/768/EEC

30.7.1976

30.1.1978

OJ L 262 of 27.9.1976

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

Directive 79/661/EEC

26.7.1979

30.7.1979

OJ L 192 of 31.7.1979

Directive 82/368/EEC

19.5.1982

31.12.1983

OJ L 167 of 15.6.1982

Directive 83/574/EEC

4.11.1983

31.12.1984

OJ L 332 of 28.11.1983

Directive 88/667/EEC

14.1.1989

31.12.1989

OJ L 382 of 31.12.1988

Directive 89/679/EEC

3.1.1990

3.1.1990

OJ L 398 of 30.12.1989

Directive 93/35/EEC

23.6.1993

14.6.1995

OJ L 151 of 23.6.1993

Directive 2003/15/EC

11.3.2003

11.9.2004

OJ L 66 of 11.3.2003

Successive amendments and corrections to Directive 76/768/EEC have been incorporated in the basic text. This consolidated version  has a purely documentary value”.

Related Acts

Non-inclusion of ingredients on labelling

Commission Directive 95/17/EC

of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non- inclusion of one or more ingredients on the list used for the labelling of cosmetic products.

Inventory and common nomenclature of ingredients

Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products [Official Journal L 132 of 1.6.1996].

Checking the composition of cosmetic products

First Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 87/143/EEC, Official Journal L 57 of 27.2.1987].

Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the Laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 90/207/EEC, Official Journal L 108 of 28.4.1990].

Third Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 291 of 24.10.1983].

Fourth Commission Directive 85/490/EEC of 11 October 1985 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 295 of 7.11.1985].

Fifth Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking composition of cosmetic products [OJ L 231 of 14.9.1993].

Sixth Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 178 of 28.7.1995].

Seventh Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 213 of 22.8.1996].

European health insurance card

European health insurance card

Outline of the Community (European Union) legislation about European health insurance card

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 > Social protection

European health insurance card

Document or Iniciative

Decision No 189 of 18 June 2003 aimed at introducing a European health insurance card to replace the forms necessary for the application of Council Regulations (EEC) No 1408/71 and (EEC) No 574/72 as regards access to health care during a temporary stay in a Member State other than the competent State or the State of residence [Official Journal L 276 of 27.10.2003].

Decision No 190 of 18 June 2003 concerning the technical specifications of the European health insurance card [Official Journal L 276 of 27.10.2003].

Decision No 191 of 18 June 2003 concerning the replacement of forms E 111 and E 111 B by the European health insurance card [Official Journal L 276 of 27.10.2003].

Summary

Following the adoption by the Barcelona European Council in March 2002 of the Skills and Mobility Action Plan and the Communication from the Commission on the introduction of a European health insurance card, the Administrative Commission on Social Security for Migrant Workers (CASSTM) approved three decisions designed to introduce a European health insurance card.

The European health insurance card will be issued by the institution of the competent State or the State of residence. So that the European card can be easily recognised by healthcare professionals and health insurance companies in the participating States, it has been designed according to a uniform model and technical specifications. Hence, two variants of the model have been defined:

  • one variant for the front of the card, the back being left to the choice of the Member State issuing the card. Besides, the card may include a chip or magnetic stripe;
  • one variant for the back of the card, if the Member State issuing the card wished to place it on the back of an existing national or regional card.

Each Member State is responsible for producing and distributing the European health insurance card in its territory, the duration of its validity being determined by the institution which issues it.

Background

The introduction of the European health insurance card, within the framework of Regulation (EEC) No 1408/71, has been based on decisions of the Administrative Commission on Social Security for Migrant Workers (CASSTM), which is made up of representatives of the Member States and is responsible primarily for promoting and developing cooperation between the Member States with a view to modernising information exchange between institutions and speeding up the provision and reimbursement of benefits.

European Agency for Safety and Health at Work

European Agency for Safety and Health at Work

Outline of the Community (European Union) legislation about European Agency for Safety and Health at Work

Topics

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

Institutional affairs > The institutions bodies and agencies of the union

European Agency for Safety and Health at Work

Document or Iniciative

Council Regulation (EC) No 2062/94 of 18 July 1994 establishing a European Agency for Safety and Health at Work [See amending acts].

Summary

The Agency’s role is to:

  • collect and analyse technical, scientific and economic information on health and safety at work in the Member States and to pass it on to the Community bodies, other Member States and interested parties;
  • collect and analyse technical, scientific and economic information on research into safety and health at work and disseminate the results of this research;
  • promote and support cooperation and exchange of information and experience amongst the Member States in the field of safety and health at work, including information on training programmes;
  • organise conferences and seminars (such as the European Health and Safety at Work Week) and exchanges of national experts in the field of safety and health at work;
  • supply the Community bodies and the Member States with the technical, scientific and economic information they require to formulate and implement judicious and effective policies designed to protect the safety and health of workers;
  • establish an information network in cooperation with the Member States, and coordinate it, including national, Community (the European Foundation for the Improvement of Living and Working Conditions) and international bodies and organisations which provide this type of information and services;
  • collect and make available information on safety and health matters from and to third countries and international organisations: the World Health Organisation (WHO), the International Labour Organisation (ILO), the Pan American Health Organisation (PAHO), the International Migration Office (IMO), etc.;
  • provide technical, scientific and economic information on methods and tools for implementing preventive activities, especially for small and medium-sized enterprises, and identify good practices;
  • contribute to the development of Community action programmes and strategies relating to the protection of safety and health at work, without prejudice to the Commission’s sphere of competence;
  • ensure that the information disseminated is easily understood by the end-users.

The Agency collaborates as closely as possible with institutions, foundations, specialist bodies and programmes at Community level in order to avoid any duplication. For example, it works together with the European Foundation for the Improvement of Living and Working Conditions.

The Agency will set up a network comprising:

  • the main component elements of the national information networks, including the national social partner organisations in accordance with national legislation;
  • the national focal points;
  • European topic centres.

Member States regularly inform the Agency of the main component elements of their information networks on health and safety at work. The relevant national authorities coordinate and forward the information to be provided to the Agency at national level.

The Agency has legal personality. Its steering and management structure comprises a Governing Board, a Bureau and a Director.
Its Governing Board comprises 78 members, of whom 25 members represent the governments of the Member States, 25 members represent employer organisations, 25 members represent employee organisations and three members represent the Commission. The Members of the Governing Board have a three-year term of office which is renewable. The Board’s headquarters is in Bilbao, Spain.

The Governing Board determines the Agency’s strategic objectives and adopts its budget, the rolling four-year programme and the annual work programme on the basis of a draft drawn up by the Director after consultation of the Commission and of the Advisory Committee on Safety, Hygiene and Health Protection at Work. By 31 January each year at the latest, the Governing Board adopts an annual general report on the Agency’s activities.

The Bureau comprises 11 members: the chairman and the three vice-chairmen of the Governing Board, one coordinator for each of the three groups of representatives (employers, workers and government), an additional representative for each of these three groups, and a Commission representative. The Bureau monitors the implementation of the Governing Board’s decisions and takes all necessary steps to ensure that the Foundation is managed properly between meetings of the Governing Board

The Agency is headed by a Director appointed by the Governing Board.

Since November 2003, the Regulation establishing the Bilbao Agency has been in line with the new Financial Regulation applicable to the General Budget of the European Communities (June 2002) and the Regulation on public access to documents (May 2001).

Establishment of the Agency

The inaugural meeting of the Governing Board took place at the Agency’s headquarters in Bilbao (Spain) on 25 and 26 October 1995.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 2062/94

18.07.1994

Official Journal L 216 of 20.08.1994

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1643/95

29.06.1995

Official Journal L 156 of 07.07.1995

Regulation (EC) No 1654/2003

30.10.2003

Official Journal L 245 of 29.09.2003

Regulation (EC) No 1112/2005

04.07.2005

Official Journal L 184 of 15.07.2005

Related Acts

Communication from the Commission to the Council regarding the Commission’s report on the European Agency for Safety and Health at Work (progress report 1996-2000) [COM(2001)163 final – Not published in the Official Journal].

Exposure to carcinogens and mutagens

Exposure to carcinogens and mutagens

Outline of the Community (European Union) legislation about Exposure to carcinogens and mutagens

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 carcinogens and mutagens

Document or Iniciative

Directive 2004/37/EC of the European Parliament and 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).

Summary

This Directive does not apply to workers exposed only to the forms of radiation covered by the Treaty establishing the European Atomic Energy Community (Euratom Treaty). It applies to workers exposed to asbestos when its provisions are more favourable than those of Directive 83/477/EEC (as last amended by Directive 2003/18/EC).
Directive 89/391/EEC applies in full, without prejudice to more binding and/or more specific provisions contained in this Directive.

In the case of any activity likely to carry the risk of exposure to carcinogens or mutagens, the nature, degree and duration of workers’ exposure must be determined on a regular basis in order to assess any risk to workers’ health or safety and decide the steps to be taken. All routes of exposure must be taken into account, including absorption into and/or through the skin. Particular attention must be paid to workers who are especially at risk.

EMPLOYERS’ OBLIGATIONS

Reduction and replacement

Employers must reduce the use of a carcinogen or mutagen, particularly by replacing it, as far as is technically possible, with a substance, preparation or process that is not dangerous or is less dangerous.

Prevention and reduction of exposure

Employers must ensure that the carcinogen or mutagen is manufactured and used in a closed system. If this is not technically possible, employers must ensure that the level of exposure is as low as is technically possible.
Exposure must not exceed the limits set out in Annex III.

Information for the competent authority

Employers must provide the competent authority, on request, with information relating to such matters as the reasons for using carcinogens or mutagens, the preventive measures taken and the number of workers exposed.

Unforeseeable exposure

In the event of unforeseeable incidents or accidents likely to lead to workers being abnormally exposed, employers must inform their workers. Protective clothing and respiratory personal protective equipment must be worn, and exposure must be kept to the strict minimum necessary.

Foreseeable exposure

For certain activities, such as maintenance work, for which the likelihood of a significant increase in exposure is foreseeable and against which all preventive measures have been taken, employers must decide the measures necessary to reduce as far as possible the amount of time workers are exposed and to ensure that they are protected during these activities. Protective clothing and respiratory personal protective equipment must be worn, and exposure must be kept to the strict minimum necessary. Moreover, the areas used for such activities must be clearly demarked and indicated.

Access to risk areas

Employers must restrict access to risk areas to workers who, by virtue of their work or duties, are required to enter such areas.

Measures regarding hygiene and personal protection

Employers are required to take the following measures regarding hygiene and personal protection for all activities that carry a risk of contamination:

  • ensure that workers do no eat, drink or smoke in work areas where there is a risk of contamination;
  • supply workers with the appropriate clothes and provide separate storage places for work clothes and street clothes;
  • provide washing and toilet facilities;
  • properly store, check and clean protective equipment before and after every use.

Workers must not bear the cost of these measures.

Informing, training and consulting workers

Employers must take appropriate steps to ensure that workers and/or their representatives receive sufficient and suitable training about:

  • potential and additional health risks (smoking);
  • precautions for preventing exposure;
  • hygiene requirements;
  • protective clothing;
  • measures to be taken in the event of an incident.

Employers must ensure that containers, packages and installations containing carcinogens or mutagens are clearly and legibly labelled, and that warning signs are clearly displayed.

Appropriate measures must be taken to ensure that workers are able to assess whether the Directive is being applied correctly. They must be informed as quickly as possible in the event of abnormal exposure.

Employers must have an updated list of workers undertaking activities that carry a risk to their health and safety in terms of exposure to carcinogens and mutagens.

Workers and/or their representatives must be consulted about and involved in all matters related to exposure to carcinogens and mutagens.

MISCELLANEOUS PROVISIONS

Health monitoring

Member States must take steps to ensure that the health of every exposed worker can be adequately monitored. These must be such that it is possible to apply individual and work-related health measures. When a worker’s health is monitored, an individual medical file is to be created.
Practical recommendations relating to the monitoring of workers’ health can be found in Annex II.
All cases of cancer identified as resulting from exposure at work must be notified to the competent authority.

Record-keeping

The up-to-date list of workers who have been exposed, which the employer is required to keep, and individual medical files are to be kept for at least 40 years after the end of exposure.

Limit values

The Council sets out in directives, where possible, limit values for all carcinogens or mutagens and, where necessary, other directly related provisions. Annex III contains the limit values for benzene, vinyl chloride monomer and hardwood dusts.

Annexes I (list of substances, preparations and processes) and III (limit values) can be amended only by the Council (Article 137 of the EC Treaty).
Technical amendments to Annex II (practical recommendations relating to the monitoring of workers’ health) are adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC.

Context

This Directive is a consolidation Directive that replaces Directive 90/394/EEC and its subsequent amendments (Directive 90/394/EEC, Directive 97/42/EC and Directive 1999/38/EC). It makes no substantive changes and merely consolidates the body of texts which it replaces. The deadlines for the transposition of Directives 90/394/EEC, 97/42/EC and 1999/38/EC into national law continue to apply.

References

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Directive 2004/37/EC

20.05.2004

Directive 90/394/EEC: 31.12.92
Directive 97/42/EC: 27.06.00
Directive 1999/38/EC:
29.04.03

OJ L 158 of 30.04.2004

Related Acts

Council Directive 1967/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances [Official Journal L 196 of 16.08.1967]

Directive of the European Parliament and the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations [Official Journal L 200 of 30.07.1999]

Advisory Committee on Safety and Health at Work

Advisory Committee on Safety and Health at Work

Outline of the Community (European Union) legislation about Advisory Committee on Safety and Health at Work

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

Advisory Committee on Safety and Health at Work (ACSHW)

Document or Iniciative

Council Decision 2003/C 218/01 of 22 July 2003 setting up an Advisory Committee on Safety and Health at Work and repealing Decisions 74/325/EEC and 74/326/EEC.

Summary

This new committee takes over the activities of the two former committees which now no longer exist:

  • the Advisory Committee for Safety, Hygiene and Health Protection at Work, set up in 1974, for all economic activities except for the extractive industries and the protection of the health of workers against the dangers arising from ionising radiation;
  • the Safety and Health Commission for the Mining and Other Extractive Industries, set up in 1957, whose remit was extended to all extractive industries.

This Committee has the task of assisting the Commission in the preparation, implementation and evaluation of all initiatives related to safety and health at work, in particular:

  • defining, within the framework of Community action programmes, the criteria and aims for preventing accidents at work and health hazards within the undertaking;
  • defining methods enabling undertakings and their employees to evaluate and improve the level of protection;
  • contributing, alongside the European Agency for Safety and Health at Work, to keeping national administrations, trades unions and employers’ organisations informed of Community measures in order to facilitate cooperation and to encourage exchanges of experience and establish codes of practice.

In order to accomplish the above tasks, the Committee cooperates with the other committees involved in safety and health at work, inter alia with the Senior Labour Inspectors Committee and the Scientific Committee for Occupational Exposure Limits to Chemical Agents.

The Committee consists of three full members from each Member State: one government representative, one trade union representative and one employers’ representative. They are appointed by the Council for a three-year term, which is renewable.

It is chaired by a Commission official.

The Committee’s opinions are delivered by an absolute majority of the votes validly cast, and reasons are given for these opinions.

Context

Given the radical changes in working life over the past few years, the opportunities opened up by enlargement and the implementation of a new Community strategy on safety and health (2002-2006), it had become necessary to streamline the operation of the two existing advisory committees. The creation of the new Committee should allow the following objectives to be achieved:

  • extending this Committee’s role to all aspects related to safety, hygiene and health protection at work;
  • integrating the activities of the various bodies involved in defining and implementing Community policy on health and safety at work (cooperation with other advisory committees and with the European Agency for Safety and Health at Work).

References

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Decision 2003/C 218/01

01.01.2004

Official Journal [C 218 of 13.9.2003]

Communication on the practical implementation of directives on health and safety at work

Communication on the practical implementation of directives on health and safety at work

Outline of the Community (European Union) legislation about Communication on the practical implementation of directives on health and safety at work

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

Communication on the practical implementation of directives on health and safety at work

Document or Iniciative

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of Regions on the practical implementation of the provisions of the Health and Safety at Work Directives 89/391 (Framework), 89/654 (Workplaces), 89/655 (Work Equipment), 89/656 (Personal Protective Equipment), 90/269 (Manual Handling of Loads) and 90/270 (Display Screen Equipment) [COM(2004) 62 – Not published in the Official Journal].

Summary

LEGAL IMPACT IN THE MEMBER STATES

Directive 89/391/EEC changed the practical perspective of the protection of the health and safety of workers by introducing an integrated preventive approach and by making ongoing improvement of health and safety conditions at work a requirement. This new approach is based on the fundamental principles which the framework Directive 89/391/EEC introduced, namely, employer responsibility, prevention, information, training, consultation and participation of workers. Directive 89/391/EEC and Directives 89/654/EEC, 89/655/EEC, 89/656/EEC, 90/269/EEC and 90/270/EEC led to the rationalisation and simplification of the National legislative corpora. Transposal of the directives obliged the Member States to switch from legislation often based on remedial principles to a preventive approach based on individual behaviour and organisational structures.

MONITORING TRANSPOSAL

Analysis of the transposal of the framework directive has made it possible to highlight shortcomings in nearly all the Member States, particularly as regards scope, employer responsibility, the principles of prevention, the extent of the obligation to evaluate risks to the health and safety of workers, protection and prevention services, the obligation to keep records of risk assessment in all types of companies and, lastly, information, consultation, participation and training of workers.
As far as individual directives are concerned, the situation as regards transposal is more positive and most of the shortcomings observed have been rectified without the need for infringement proceedings, which have, however, been necessary in certain cases.

ACTION ON THE GROUND: PRACTICAL IMPLEMENTATION

Substantial heterogeneousness continues to exist in the practical implementation of the various directives, depending on the countries, the different sectors of activity and the size of company. Nevertheless, the primary aims of guaranteeing common minimum standards of protection through harmonisation of the recommendations on safety and health, reducing the number of accidents at work and the number of cases of occupational diseases, have been attained.

Publicity and supporting measures

Although National (action plans and awareness-raising campaigns) and European (role of the European Agency for Health and Safety at Work) measures have contributed greatly to better understanding of the new legislation and better awareness by employers and workers alike of their rights and obligations, the impact of these measures varies depending on the economic players to whom they apply. While things run smoothly from this point of view in the bigger companies, this is not the case in the small and medium-sized enterprises (SMEs), where a big effort is needed.

Awareness raising

Despite the huge volume of information available, the level of information among employers and workers, particularly in the SMEs, is insufficient. Employers point to problems in understanding the legislation. This stems from the nature of the provisions, which involve establishing a general objective, and from the fact that there is no information at National level to help employers establish prevention plans tailored to the risks detected in the risk assessment.

Risk assessment, documentation and supervision

The points to be improved concerning the practical implementation of the provisions related to the risk assessment are:

  • superficial, schematic procedures place tend to focus on obvious risks, while long-term effects (e.g. psychological and psycho-social factors) as well as the more insidious risks, e.g. those caused by chemical substances, are neglected;
  • as a result, there is no overall or integrated approach to risks and measures are taken in isolation;
  • risk assessment is often considered as a one-off obligation and lacks continuity;
  • the effectiveness of steps taken is not sufficiently monitored by employers.

Protective and preventive services

Not all companies comply with their obligation to set up departments to protect against and prevent occupational risks, either by designating a worker to carry out such activities or, if this is not possible, by calling in an external service. This is particularly the case of the SMEs.
The introduction of such services is held up by the lack of qualified personnel, the low quality of the services delivered (unilateral importance attached to the technical aspects, few multi-disciplinary services) and by the tendency for employers to use the cheapest possible services.

Information, consultation, participation and training

Few data are available on information flow but it is clear that the practical implementation of the obligation to inform workers leaves a lot to be desired by comparison with the other obligations which employers have to comply with. This is the case of nearly all the industrial sectors in all the Member Stakes irrespective of size of company. The problem is particularly manifest among temporary workers. Nor is the participation of workers organised satisfactorily despite the range of options proposed by the directives.

Organisation and management of health and safety at work

The growing complexity of work processes, trends in working conditions and changes in the types of risks encountered as a result, call for a transparent and systematic approach to health and safety at work. Yet, with the exception of the bigger companies, safety and health are seldom an integral part of companies’ overall management process.

Enforcement

Enforcement of health and safety at work legislation is primarily a matter for the labour inspectorates, often working in conjunction with other specialised monitoring agencies in certain sectors of activity. The progress made with implementation by the Member States is generally measured taking the ratio between the number of labour inspectors in each Member State and the number of inspections performed every year. 1 400 000 inspections are carried out every year in the European Union by approximately 12 000 inspectors.

The entry into force of the new EU health and safety legislation and does not appear to have boosted the number of inspections. In their reports, the Member States point to a chronic lack of resources in their labour inspectorates to cover all aspects of the new legislation, particularly in the SMEs.

The analysis carried out shows that the action of the EU labour inspectorates actively contributes to bringing down the rate of absenteeism due to occupational accidents and diseases and also to changing the approaches of those involved in prevention at workplace level. Further progress is needed in order to improve checks in the SMEs and the high-risk sectors and in order to make warnings and sanctions more dissuasive.

Analysis of two specific cases: SMEs and the public sector

SMEs

The analysis shows that there are major shortcomings in complying with essential elements of EU health and safety legislation in SMEs, in particular as regards risk assessment, workers’ participation and training, and in the traditionally high-risk sectors of agriculture and construction. These shortcomings stem primarily from:

  • the lack of information and specific (targeted information distributed locally) and comprehensible guidelines;
  • poor capacity and skills in terms of health and safety;
  • lack of resources to ensure appropriate basic training of workforce and managers;
  • poor access to effective, specific and specialised technical assistance.

The public sector

The inclusion of the public sector within the scope of the health and safety legislation is a groundbreaking development in most Member States.

Despite problems in certain countries (particularly in the military sector), the transposal of European legislation in the public sector can all in all be considered to be satisfactory. The degree to which it is implemented nonetheless poses certain problems because:

  • it is widely held in public administration that the risk levels are negligible by comparison with the private sector;
  • it is not generally for labour inspectorates to intervene in public administration or the in-house departments responsible for this function do not have enough hierarchical autonomy;
  • the budgets allocated are often limited.

EVALUATION OF THE EFFECTIVENESS OF THE LEGISLATION

The National reports show that the majority of Member States consider that it is as yet too early to make a proper and full evaluation of effectiveness. Although nearly all Member States believe there has been a positive impact, they do not have the data or statistical results available yet to substantiate that impact. Nevertheless, the evaluation that the legislation has contributed to making the workplace safer is supported by general statistical data on occupational health and safety.

Effects on accidents at work and occupational diseases

The most up-to-date statistics (for the year 2000) show that the accident rate per 100 000 workers had fallen from 4513 to 4016 since 1994. Also by comparison with 1994, there was a marked improvement in the rate of fatal accidents in Europe, which fell back from 6423 to 5237 in 2000.

The 1999 labour force survey and those conducted by the European Foundation for Living and Working Conditions, for their part, show that the active population feels that working conditions have not improved overall. A great deal remains to be done with regard to monitoring and organising work in order to head off intensive working patterns, problems stemming from working on screen, repetitive movements and psychological damage.

Costs and benefits in the enterprises

Member States have indicated in their National reports that due to the lack of indicators they consider that it is not possible to make a full evaluation, but acknowledge that a reduction in accidents at work and worker absenteeism brings about a clear reduction in business costs, which should in turn boost productivity.

General economic effects

In the European Union the costs for accidents at work and work-related illnesses are estimated between 2.6 and 3.8% of the gross National product (GNP). 158 million days of work were lost in the Union in 2000. Around 350 000 workers were obliged to change their job as a result of an accident. Nearly 350 000 workers have various degrees of permanent disability and 15 000 have been forced out of the labour market. However, the fall in the number of accidents at work since the entry into force of Community legislation is estimated to have generated savings of 25 million days of work.
So, while the implementation of this legislation may not be totally satisfactory, it has definitely produced economic benefits.

Effects on employment and competitiveness

The beneficial effects of investment in health and safety at work take some time to filter through. This makes it very difficult for the time being to draw conclusions on the impact of the legislation in question on the competitiveness of the business sector. Cost/benefit analyses will have to be carried out in order to evaluate the short and longer term effects. As an overall conclusion, Member States in their National reports generally indicate that health and safety at work measures contribute towards improved working conditions, boosting productivity, employment and competitiveness.

OVERALL EVALUATION OF IMPLEMENTATION

Positive effects, problems with implementation and suggestions for improving the various Directives

  • Framework Directive 89/391/EEC

-This downward trend in the number of accidents at work and the aforementioned increase in employers’ awareness are considered by the Member States to be the great achievement of Directive 89/391/EEC. The following positive points were also mentioned:

  • emphasis on a prevention philosophy;
  • broadness of scope;
  • obligation for the employers to perform risk assessments and provide documentation;
  • obligation for the employer to inform and train workers;
  • rights and obligations of the workers;
  • the opportunity to consolidate, rationalise and simplify the National regulations in force.

The main problems pointed to by the Member States arose in the SME context and concerned the administrative obligations and formalities, the financial burden and at the time needed to prepare appropriate measures. Other difficulties were:

  • the lack of participation by the workers in the operational processes;
  • the absence of evaluation criteria for National labour inspectorates;
  • the lack of harmonised European statistical information system on occupational accidents and diseases;
  • problems in implementing certain provisions in the SMEs.

– If the degree of implementation of the directive is to be improved then there is a need to:

  • increase the level of application of the Directives in SMEs;
  • ensure the availability of comprehensive and harmonised statistics on occupational accidents;
  • provide easy access to information and assistance for employers and workers to make them aware of their rights and obligations;
  • step up action and allocate the resources necessary to guarantee uniform, effective and equivalent implementation;
  • identify any provisions of the Directives that have been outdated by technological development and need to be reviewed;
  • focus greater attention on the specific situation of temporary workers.
  • Directive 89/654/EEC on workplaces

– The positive aspects:

  • regulation of various situations which would not have received the required attention had they not been dealt with by the European Directive, e.g. windows, translucent partitions, doors or gates opening upwards, emergency routes and exits, etc.;
  • reinforcing regulations on the employers’ obligations relating to workplaces used for the first time, and workplaces already in use.

Implementation difficulties:

  • excessive detail concerning certain aspects, this being detrimental to the proper transposal of the directive ;
  • unclear distinction made by the Directive between workplaces used for the first time and those already in use ;
  • the investment required to adopt the new provisions in SMEs.

– Suggestions for improvement:

  • the need for a co-ordinated approach to the problems regarding environmental conditions, e.g. by exchange of relevant experience among Member States;
  • the establishment of guidelines and recommendations (with up-to-date data, charts and figures) in order to clarify certain aspects (ventilation, lighting, temperature, dimensions of the workplace, etc.);
  • examining the provisions which are applicable to teleworking.
  • Directive 89/655/EEC on the use of work equipment by workers at work

-The positive points:

  • minimum safety level for work equipment defined;
  • National regulations unified and harmonised, which has contributed towards simplification;
  • scope extended to a greater number of items of work equipment;
  • standards generally clearer and more specific;
  • employer awareness raised with regard to the safety level of work equipment;
  • adaptation, official approval and modernisation of work equipment in use;
  • more active prevention of risks associated with the use of work equipment;
  • better analysis of factors to be taken into account when acquiring new equipment.

– Implementation difficulties:

  • excessive cost for SMEs which do not have the necessary financial resources;
  • the need for long-term investment to adapt work equipment;
  • the practical distinction between the Directive on safety in the use of work equipment and the machinery Directive has not been made sufficiently clear;
  • the definition of various safety levels for a machine already in use and for a new machine makes it difficult to adapt it to the requirements of the Directive.

-Suggestions for improvement:

  • clarification of the various safety levels for a machine in use and for a new machine;
  • support measures to smooth over the implementation of the directive, particularly for the SMEs: financial aid, loans, etc;
  • publication of guidelines on the practical part of the provisions.
  • Directive 89/656/EEC on the use by workers of personal protective equipment

– The positive points:

  • National legislation has been standardised, simplified and co-ordinated;
  • extension of the regulations to new sectors and new equipment ;
  • obligation on the employer to assess risks before selecting individual protection equipment and a widespread increase in awareness as regards the conditions to be met by this equipment;
  • greater detail in the regulations, which entail, for instance, knowing the exact type of activities in which certain individual protection equipment is mandatory.

– Implementation difficulties:

  • lack of assistance for SMEs, which have difficulty in selecting suitable protection equipment by themselves;
  • cost of new equipment for small companies;
  • workers insufficiently familiar with the use of personal protective equipment.

– Suggestions for improvement:

  • the Commission should publish specific guidelines and codes of good practice, which would include selection criteria for personal protective equipment;
  • supplement the annexes to the directive in order to make it easier for companies to choose equipment;
  • synchronisation and simplification of implementation reports.
  • Directive 90/269/EEC on the manual handling of loads

– The positive points:

  • support for existing regulations on manual handling of loads in some Member States;
  • regulations which are clear and have been generally applied without problems;
  • improvements in the level of awareness of employers (taking on board the ergonomics aspects in risk assesment);
  • these obligations have been put into practice in nearly all sectors of industry.

– Implementation difficulties:

  • job losses could result from a high level of mechanisation and costs;
  • some aspects of the Directive are considered too detailed (although this is considered a positive aspect in some Member States);
  • the possibility that a series of workplaces may cease to be considered as suitable for women;
  • the absence of standards other than those of load weight and distance, regarding rest periods and rest intervals.

– Suggestions for improvement:

  • several Member States are of the opinion that limit values should be set, since the margin for interpretation allowed as regards manual handling of loads is excessive;
  • the Commission should give details concerning evaluation models and guidelines;
  • the application of ergonomics principles to the handling of materials should be given closer attention.

Directive 90/270/EEC on work with visual display equipment

– The positive points:

  • further support for control and improvement of the ergonomics aspects of workstations using visual display equipment;
  • introduction of rest periods and the workers’ right to better health surveillance, in particular eye tests;
  • these obligations have been put into practice in nearly all sectors of the industry.

– Implementation difficulties

  • a number of problems are difficult to solve (use of natural light, the ergonomics aspects of seating, the inability to neutralise certain electromagnetic fields);
  • confusion as to who is authorised to or should carry out eye tests;
  • problems stemming from teleworking and supervision of working conditions within that framework.

– Suggestions for improvement:

  • it would be advisable to specify the provisions on changes of activity or rest periods, as well as the persons to whom they should apply;
  • the problems caused by electromagnetic radiation from terminals, lasers and magnetic fields should be examined;
  • various Member States consider a review of the Directive to be appropriate, in order to adapt it to technological development.

BACKGROUND

The analysis concerns the transposition and application of the framework directive 89/391 on the introduction of measures to encourage improvements in the safety and health of workers at work as well as of the first five individual directives, addressing particular workplace environments or risks. The individual directives concern in particular:

  • minimum requirements for the workplace (Directive 89/654/EEC)
  • the use of work equipment (Directive 89/655/EEC)
  • personal protective equipment (Directive 89/656/EEC)
  • manual handling of loads (Directive 90/269/EEC)
  • display screen equipment (Directive 90/270/EEC)

This report is the Commission’s response to the call made in the framework directive and in the five individual directives to “submit a report on the implementation of the various directives at regular intervals to the European Parliament, the Council and the Economic and Social Committee”

A major input to this Communication are the National reports provided by the Member States in accordance with the directives which state that “Member States shall report to the Commission every five years (every four years for Directives 90/269 and 90/270) on the practical implementation of the provisions of this Directive, indicating the points of view of employers and workers”. It is also based on a report by independent experts.

Key figures of the act (for the year 2000)

  • Number of accidents (having resulted in absence from work of over three days): for 100.000 workers, 4016 cases (4539 in 1994);
  • Fatal accident rate: 5237 cases (643 in 1994);
  • Cost of accidents at work and of occupational diseases: between 2.6 and 3.8% of GDP
  • Days of work lost as a result of accidents at work: 158 million;
  • 7% of accident victims are forced to change jobs;
  • 4% of accident victims have to reduce their working hours or suffer varying degrees of permanent disability;
  • 15.000 workers were forced out of the employment market for good following an accident at work;
  • 14% of workers have more than one accident per year.

Protection of young people at work

Protection of young people at work

Outline of the Community (European Union) legislation about Protection of young people at work

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

Protection of young people at work

Document or Iniciative

Council Directive 94/33/EC of 22 June 1994 on the protection of young people at work.

Summary

The Directive applies to all young people under the age of 18 who have an employment contract or an employment relationship defined by the law in force in a Member State and/or subject to the law in force in a Member State.

The Member States may stipulate that the Directive shall not be applicable to occasional work or work carried out for a limited period in domestic service in a private household or to work in a family business which is not considered likely to harm, injure or endanger young people.

The Directive provides that the Member States shall take the necessary measures to prohibit the employment of children and shall ensure that the employment of adolescents is strictly controlled and protected under the conditions provided for in the Directive.

The Directive defines categories of young people as follows:

  • young people: young people under the age of 18;
  • children: young people under the age of 15 or who are still in full-time compulsory education in accordance with national legislation;
  • adolescents: young people between the ages of 15 and 18 who are no longer in full-time compulsory education in accordance with national legislation.

The Directive’s main objective is to prohibit the employment of children.

However, the Directive allows the Member States to stipulate, subject to certain conditions, that the ban on the employment of children is not applicable to:

  • children employed for the purposes of cultural, artistic, sporting or advertising activities, subject to prior authorisation by the competent authority in each specific case;
  • children aged 14 years or over who work in an undertaking as part of a work/training scheme or traineeship, provided that this work is carried out in accordance with the requirements laid down by the competent authority;
  • children aged 14 years or over performing light work other than that referred to in the first point above ; however, children over 13 may perform light work for a limited number of hours per week in categories of employment defined in national legislation.

The Directive includes provisions relating to:

  • the employer’s general obligations, such as protection of the health and safety of young people, assessment of the risks to young people associated with their work, assessment and monitoring of the health of young people, information about young people and children’s legal representatives on the possible risks to their health and safety;
  • types of employment which must not be carried out by young people, such as work which exceeds the mental or physical capacities of young people, work involving harmful exposure to dangerous substances.

In addition, the Directive contains provisions relating to working hours, night work, rest periods, annual leave and rest breaks.

Each Member State is responsible for defining the measures to be taken in the event of infringement of the provisions of this Directive. These measures must be effective and proportionate to the offence.

The Directive contains a non-regression clause concerning the level of protection for young people.

The Directive provides for transition periods of varying lengths for Member States for which the application of this Directive poses significant problems. This is the case for the United Kingdom, which has a transition period of four years to apply some of the most important provisions of the Directive, i.e. until 22 June 2000.

References

Act

Entry into force

Deadline for transposition in the Member States

Official Journal

Council Directive 94/33/EC

22.06.1996

Official Journal L 216 of 20.08.1994

Related Acts

Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of Regions on the application of Directive 94/33/EC on the protection of young people at work [COM(2004) 105 final].

The report concludes that in most Member States the legislation already made provision for the protection of young workers and the prohibition of child labour before the Directive was adopted. There were therefore no significant problems in transposing the Directive.

Report from the Commission on the effects of the transitional period granted to the United Kingdom concerning certain provisions of Council Directive 94/33/EC on the protection of young people at work [COM(2000)457 final].

Protection of workers from exposure to biological agents

Protection of workers from exposure to biological agents

Outline of the Community (European Union) legislation about Protection of workers from exposure to biological agents

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

Protection of workers from exposure to biological agents

Document or Iniciative

Directive 2000/54/EC of the European Parliament and the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC).

Summary

This Directive protects the health and safety of workers exposed to biological agents * whilst undertaking their work.

Biological agents are classified into four risk groups, according to the risk of infection involved:

  • group 1 includes agents that are unlikely to cause human disease;
  • group 2 concerns agents that can cause human disease but are unlikely to spread to the community, for which effective treatment is available;
  • group 3 includes agents that can cause human disease and may spread to the community, although prevention or treatment is possible;
  • group 4 concerns agents that can cause severe human disease. They present a high risk of spreading to the community, for which there is no effective treatment.

Risk assessment

Risk assessment must be carried out for all professional activities that may expose workers to biological agents. The nature, degree and duration of exposure shall be determined in order to plan preventive measures.

The employer shall participate in regular risk assessments.

Employers’ obligations

If the activity so permits, the employer must replace the harmful agents with agents that are not dangerous or are less dangerous, considering their conditions of use and the level of scientific knowledge thereof.

Moreover, if there is a risk to the safety or health of workers, the employer shall ensure that such risk is reduced to a sufficiently low level. The employer may:

  • limit the number of workers exposed to a minimum;
  • control the release of agents into the workplace, using technical procedures;
  • organise collective and/or individual protection measures;
  • prevent or reduce accidental release outside the workplace, using hygiene measures;
  • install risk warning signs;
  • draw up plans to deal with accidents;
  • provide for the collection, storage and disposal of waste;
  • arrange for safe handling conditions and transport of biological agents.

The employer is obliged to keep a list of workers exposed to group 3 and/or group 4 agents. This list may be kept for up to 40 years in some cases. Furthermore, the employer shall inform the competent national authority when group 2, group 3 or group 4 biological agents are used for the first time.

Lastly, the employer shall ensure that workers and/or their representatives are sufficiently informed and trained, concerning:

  • potential risks to health;
  • precautions to be taken to prevent exposure;
  • hygiene rules;
  • use of protective equipment and clothing;
  • measures to be taken in the case of incidents.

If there is an accident or incident, the employer shall inform workers and/or their representatives as soon as possible of the causes, risks and measures to be taken.

Health surveillance

The Member States shall establish arrangements to carry out the health surveillance of workers, prior to and following exposure to biological agents.

Context

Directive 90/679/EEC on the risks related to exposure of workers to biological agents is repealed.

Key terms
  • Biological agents: micro-organisms, including those which have been genetically modified, cell cultures and human endoparasites, which may be able to provoke any infection, allergy or toxicity.
  • Micro-organism: a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material.
  • Cell culture: the in-vitro growth of cells derived from multicellular organisms.

References

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

Directive 2000/54/EC

18.9.2000

6.11.2000

OJ L 262 of 17.10.2000