Tag Archives: Marketing

Application of certain EU competition rules to agricultural products

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Application of certain EU competition rules to agricultural products

Outline of the Community (European Union) legislation about Application of certain EU competition rules to agricultural products

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

Agriculture > General framework

Application of certain EU competition rules to agricultural products

Document or Iniciative

Council Regulation (EC) No 1184/2006 of 24 July 2006 applying certain rules of competition to the production of and trade in certain agricultural products [See amending acts].

Summary

This regulation states that, except for certain exceptions detailed below, Articles 101 to 106 of the Treaty on the Functioning of the European Union (TFEU) (ex-Articles 81 to 86 of the Treaty Establishing the European Community (TEC)) apply to all agreements, decisions and practices referred to in Articles 101(1) and 102 TFEU (ex-Article 81(1) and 82 TEC) relating to the production of, or trade in, agricultural products.

There are three exceptions. These general rules do not apply to:

  • agreements, decisions and practices that form an integral part of a national market organisation;
  • agreements, decisions and practices that are necessary in order to attain the objectives of the common agricultural policy (CAP);
  • certain agreements, decisions and practices of farmers or farmers’ associations belonging to a single European Union (EU) country, provided such agreements do not introduce an obligation to charge identical prices, exclude competition or jeopardise the objectives of the CAP.

References

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

Regulation (EC) No 1184/2006

24.8.2006

–

OJ L 214, 24.6.2006
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1234/2007

23.11.2007

–

OJ L 299, 16.11.2007

Regulation (EC) No 361/2008

14.5.2008

–

OJ L 121, 7.5.2008

Regulation (EC) No 491/2009

24.6.2009

–

OJ L 154, 17.6.2009

Successive amendments and corrections to Regulation (EC) No 1184/2006 have been incorporated into the basic text. This consolidated versionis for reference only.

State aid in the agriculture sector

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State aid in the agriculture sector

Outline of the Community (European Union) legislation about State aid in the agriculture sector

Topics

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

Agriculture > General framework

State aid in the agriculture sector

Document or Iniciative

Community guidelines for state aid in the agriculture and forestry sector 2007-13 [Official Journal C 319 of 27.12.2006].

Summary

The guidelines cover state aid in the agriculture and forestry sector for the period 2007-13 and replace the previous guidelines (2000-06) established for agriculture.

These guidelines apply to state aid granted for the production, processing and marketing of agricultural products. Annex I of the Treaty on the Functioning of the European Union (TFEU) provides a detailed list of the agricultural products included. They do not apply to the fisheries and aquaculture sector but, unlike the previous ones (2000-06), are applicable for aid for some forestry activities.

European Union (EU) countries are still obliged to notify the Commission of state aid for certain Annex I products that are not covered by a common market organisation (CMO), but the Commission may only make observations on the aid schemes. EU countries are invited to take on board these observations to avoid the risk of infringement procedures.

State aid is categorised in the guidelines as follows:

  • rural development measures;
  • aid for risk and crisis management;
  • other types of aid;
  • aid for the forestry sector.

RURAL DEVELOPMENT MEASURES

In line with Regulation (EC) No 1698/2005, which regulates EU support for rural development (the second pillar of the Common Agricultural Policy (CAP)), the guidelines set out the rules governing state aid for rural development measures or other closely related measures.

Aid may be authorised for investment in agricultural holdings in the following cases:

  • aid for investment in agricultural holdings proper;
  • aid for the conservation of traditional landscapes and buildings;
  • aid to relocate farm buildings where this is done in the public interest;
  • aid for necessary investment to improve the environment, hygiene conditions and animal welfare;
  • aid for additional costs due to investment made in EU countries to implement Directive 91/676/EEC;
  • aid for investment in compliance with applicable EU or national rules (only for additional costs incurred by young farmers to implement the rules within 36 months of their establishment).

Aid for investment in connection with the processing and marketing of agricultural products is authorised where it meets the conditions laid down in one of the following provisions:

  • Commission Regulation (EC) No 800/2008;
  • the Commission guidelines on national regional aid for 2007–13.

Environmental and animal welfare aid must meet the general objectives of EU environmental policy. This consists of the precautionary principle and the principles that preventive action should be taken, that as a priority environmental damage should be rectified at source and that the polluter should pay.

Aid to compensate for handicaps in certain areas must contribute to maintaining land use for agriculture, conserving rural areas and maintaining and promoting sustainable farming systems. To qualify for this aid, EU countries must demonstrate the handicaps in question and provide proof that the amount of aid avoids any overcompensation of these handicaps. The level of compensatory payments must be proportionate to the economic impact of the handicaps. Only the economic impact of permanent handicaps that lie outside human control may be taken into account for calculating the amount of compensatory payments.

Aid for meeting standards is designed to cover part of the costs incurred and loss of income as a result of applying standards in the fields of environmental protection, public health, animal and plant health, animal welfare and occupational safety.

Aid for the setting up of young farmers is for persons under 40 years of age who are setting up an agricultural holding for the first time as farm manager. Eligible beneficiaries may also submit a plan to develop their agricultural activities.

Aid for early retirement or for the cessation of farming activities is authorised subject to the conditions for permanent and definitive cessation of commercial farming activities.

Aid for producer groups aims to encourage the establishment of producer groups to concentrate their supply and adapt their production to market requirements. This aid is limited to small and medium-sized enterprises (SMEs). Eligible expenditure includes: rental of suitable premises, purchase of office equipment, including computer hardware and software, administrative costs (including staff), overheads and other expenses.

Aid for land reparcelling aims to support the exchange of plots of agricultural land and to facilitate the establishment of economically viable holdings. Aid may only be granted to cover the legal and administrative expenses involved in reparcelling up to 100 % of actual expenditure incurred.

Aid to encourage the production and marketing of quality agricultural products aims to improve the quality of agricultural products and to encourage farmers to participate in food quality schemes.

Under technical support in the agricultural sector, aid may be granted for the following measures:

  • education and training provided to farmers and agricultural workers;
  • replacement services to cover farmers’ absence due to holiday or sickness;
  • consultancy services provided by third parties;
  • organisation of forums to pool knowledge between enterprises and organisation of and participation in competitions, exhibitions or fairs;
  • publication of factual or scientific data;
  • publications.

Aid in the livestock sector targets support for the maintenance and improvement of the genetic quality of EU livestock.

Aid for the outermost regions and the Aegean islands aimed at meeting the needs of these regions will be examined by the Commission on a case by case basis, in accordance with the specific legal provisions applying to these regions, and with regard to the compatibility of the measures concerned with rural development programmes for the regions concerned.

RISK AND CRISIS MANAGEMENT

State aid may be granted to manage crises in the sector of primary agricultural production. However, distortions of competition must be avoided as far as possible. Requiring a minimum contribution from producers to losses or the cost of such measures provides an incentive for minimising risk. The following risk and crisis management measures are eligible for state aid:

  • aid to compensate for damage to agricultural production or the means of agricultural production;
  • aid regarding TSE (transmissible spongiform encephalopathies) and fallen stock;
  • aid towards the payment of insurance premiums;
  • aid for closing production, processing and marketing capacity.

Aid for rescuing and restructuring firms in difficulty will be assessed in accordance with the applicable EU guidelines on state aid for rescuing and restructuring firms in difficulty.

OTHER TYPES OF AID

Regulation (EC) No 800/2008 provides certain conditions under which aid for employment and aid for research and development are authorised.

There are horizontal aid instruments applicable to the agriculture sector. State aid for the agriculture sector is also covered by more general rules on the compatibility of aid with the TFEU, such as training aid (which is also covered by Regulation (EC) No 800/2008), state aid in connection with investment capital, state aid in the form of guarantees and state aid in the form of public service compensation.

Aid for advertising agricultural products may be authorised if the advertising campaign is centred on quality products – recognised EU designations (such as registered designation of origin – protected designation of origin (PDO) and protected geographical indication (PGI)) or for national or regional quality labels. Advertising campaigns must not be dedicated directly to the products of one or more particular company or companies.

Aid linked to tax exemptions under Directive 2003/96/EC may be granted by applying reduced or zero rates of taxation, provided that no differentiation is made in the agricultural sector. This covers products used as fuel for primary agricultural production or energy and electricity products used for primary agricultural production.

Aid in the form of subsidised short-term loans is no longer authorised.

AID FOR THE FORESTRY SECTOR

Up to now there have not been any specific EU rules governing state aid for the forestry sector. Aid could be granted under EU general rules for all sectors or under certain specific regulations. In the interests of transparency, the Commission has therefore sought to more clearly define EU policy on state aid for the forestry sector. However, the guidelines apply only to living trees and their natural environment in forests and other wooded land. They do not apply to state aid for forest-based industries, timber transport, wood processing or other forestry resources used as products or for the purpose of energy generation.

Aid in the forestry sector is authorised for the following purposes:

  • to contribute directly towards maintaining and enhancing the ecological, protective and recreational functions of forests, local biodiversity and a healthy forest ecosystem;
  • afforestation of agricultural and non-agricultural land, establishment of agri-forestry systems on agricultural land, Natura 2000 payments, payments for the forestry environment, restoring forest potential, introducing prevention systems, and non-productive investments;
  • to cover additional costs and loss of revenue linked to using more demanding environmentally friendly forestry techniques than those imposed by the rules, if the owners concerned undertake voluntarily to use these techniques and this commitment meets certain conditions;
  • to purchase forestry land, provided that the intensity of aid is within the limits set for aid for investment in agricultural holdings;
  • training for forestry owners and workers and for consultancy services provided by third parties;
  • setting up forestry associations;
  • support for initiatives to spread new techniques, pilot or demonstration projects under the conditions laid down in the chapter on technical assistance in the agricultural sector in the guidelines.

PROCEDURES

All new aid schemes and all new aid must be notified to the Commission before they are implemented, unless the aid is covered by one of the exemption regulations adopted by the Commission. In contrast to the guidelines for 2000-06, only aid schemes of limited duration are now authorised, with the maximum duration being seven years. These new guidelines apply from 1 January 2007.

EU countries must submit annual reports and the Commission reserves the right to request additional information.

These guidelines apply until 31 December 2013. However, the Commission reserves the right to amend them in the light of important considerations of competition policy, agricultural policy, human and animal health or in order to take account of other EU policies or international commitments.

BACKGROUND

The new guidelines form part of the 2003 reform of the CAP, which confirms the importance of rural development and shows the Commission’s concern to make aid granted by EU countries in the agriculture sector more coherent. The guidelines for the period 2007-13 are based on Regulation (EC) No 1698/2005 on support for rural development by the European Agricultural Fund for Rural Development, and in particular Articles 88 and 89 thereof, which contain specific provisions regarding state aid.

Placing on the market and administration of bovine somatotrophin

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Placing on the market and administration of bovine somatotrophin

Outline of the Community (European Union) legislation about Placing on the market and administration of bovine somatotrophin

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Food safety > Veterinary checks animal health rules food hygiene

Placing on the market and administration of bovine somatotrophin

Document or Iniciative

Council Decision 1999/879/EC of 17 December 1999 concerning the placing on the market and administration of bovine somatotrophin (BST) and repealing Decision 90/218/EEC.

Summary

This Decision is intended to regulate the marketing and use of bovine somatotrophin, or bovine growth hormone, within the European Union (EU).

The Decision thus prohibits the placing on the market of bovine somatotrophin on EU territory for the purpose of its marketing and the administration thereof to dairy cows by any means whatsoever.

The production or importation of bovine somatotrophin in the Member States for the purposes of exporting it to third countries continues to be authorised.

In addition, undertakings which produce or are authorised to market somatotrophin are required to keep registers detailing, in chronological order, the quantities produced or acquired and the quantities sold or used for purposes other than placing on the market, as well as the names of the persons to whom such quantities were sold or from whom they were purchased.

Background

In accordance with Directive 2001/82/EC, no substance, with the exception of those given for therapeutic or prophylactic purposes, is to be administered to an animal unless it has been demonstrated by scientific studies of animal welfare or established experience that the effect of that substance is not detrimental to the health or welfare of the animal.

Somatotrophin is produced only to enhance milk production, and the Scientific Committee on Animal Health and Animal Welfare (which has been replaced by the European Food Safety Authority) stated in March 1999 that somatotrophin increased the risk of infections in cattle and that it could adversely affect reproduction and induce severe reactions in cattle to which it was administered.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Decision 1999/879/EC 01.01.2000 – OJ L 331 of 23.12.1999

Colouring matters for medicinal products

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Colouring matters for medicinal products

Outline of the Community (European Union) legislation about Colouring matters for medicinal products

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Internal market > Pharmaceutical and cosmetic products

Colouring matters for medicinal products (recast)

Document or Iniciative

Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (recast) (Text with EEA relevance).

Summary

This Directive gives specifications on colouring matters for medicinal products.

Only the colouring matters listed in Annex I to Directive 94/36/EC may be used to colour medicinal products for human and veterinary use.

The colouring matters referred to in Annex I must meet the general specifications for aluminium lakes of colours and the specific criteria of purity laid down in Annex I to Directive 95/45/EC. The methods of analysis needed to verify these criteria are framed by Directive 81/712/EC.

When a colouring matter is deleted from Annex I to Directive 94/36/EC, but the marketing of foodstuffs containing this colouring matter is permitted to continue for a limited period, this additional period of use also extends to medicinal products. However, the Commission may amend the duration of this additional period.

The Commission shall be assisted by a committee for the adjustment to technical progress of the Directives composed of representatives from Member States and chaired by a Commission representative.

This Directive repeals Directive 78/25/EC.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 2009/35/EC

20.5.2009

–

OJ L109 of 30.4.2009

This summary is for information only. It is not designed to interpret or replace the reference document, which remains the only binding legal text.

Narcotic drugs and psychotropic substances: internal aspects

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Narcotic drugs and psychotropic substances: internal aspects

Outline of the Community (European Union) legislation about Narcotic drugs and psychotropic substances: internal aspects

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Other

Narcotic drugs and psychotropic substances: internal aspects

1) Objective

To prevent the manufacture of narcotic drugs and psychotropic substances legitimately marketed in the Community from being diverted for illicit purposes.

2) Document or Iniciative

Council Directive 92/109/EEC of 14 December 1992 on the manufacture and the placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances [Official Journal L 370, 19.12.1992].

3) Summary

The Directive distinguishes two types of precursor: those with limited use for licit purposes, and those of essential importance for legitimate commercial use.

The Directive defines “scheduled substance”, “placing on the market”, “operator”, “UN Convention” and “International Narcotics Control Board”.

The Directive lays down requirements in respect of documentation, records and labelling. It guarantees the competent authorities access to documents and records for verification purposes.

Member States must designate a competent authority in order to ensure proper application of the Directive. The Directive also requires intra-Community cooperation between the competent authorities.

Member States are to take all appropriate measures to encourage operators to notify the competent authorities of all unusual orders or transactions relating to scheduled substances which show that the substances which are to be placed on the market or manufactured are likely to be used in the illicit manufacture of narcotic drugs or psychotropic substances. Likewise, the Member States shall encourage all persons who suspect, from information obtained by reason of their professional duties, that scheduled substances which have been, or are about to be, placed on the market or manufactured are likely to be used for the illicit manufacture of narcotic drugs or psychotropic substances, to inform the competent authorities thereof.

With regard to the control measures, the Directive confers on the competent authorities powers of inspection, search and seizure. The competent authorities may prohibit the placing on the market or manufacture of scheduled substances if they believe that these substances are ultimately destined for the illegal manufacture of narcotic drugs or psychotropic substances.

An annual report drawn up by the Commission will be submitted to the International Narcotics Control Board. The report will provide information on the amounts of scheduled substances seized, the methods of diversion and illicit manufacture, any substances identified as having being used in illicit manufacture of narcotic drugs or psychotropic substances, and the nature and origin of processing equipment seized.

Act Date
of entry into force		 Final date for implementation in the Member States
Directive 92/109/EEC 01.07.1993 01.07.1993

4) Implementing Measures

Regulation (EC) No 1485/96 [Official Journal L 188 of 27.7.1996]
Commission Regulation of 26 July 1996 setting out the conditions for implementing Council Directive 92/109/EEC with regard to customer declarations which specify the uses of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances.
According to this Regulation, a customer who purchases a classified substance falling within categories 1 or 2 in Annex I to Directive 92/109/EEC must complete a declaration on his supplier’s premises that specifies the use(s) of that substance. The Regulation also provides that a specific declaration shall be drawn up which covers multiple transactions in the substances falling within category 2.

This Regulation was amended by:

Commission Regulation No 1533/2000 of 13 July 2000 [Official Journal L 175 of 14.07.2000]

This Regulation amends the model declarations of use in respect of individual and multiple transactions, and establishes a uniform model for all operators so as to facilitate the monitoring of these declarations by the Member State authorities.

Recommendation [Official Journal C 114 of 15.05.2002]

Council Recommendation of 25 April 2002 on the need to enhance cooperation and exchanges of information between the various operational units specialising in combating trafficking in precursors in the Member States of the European Union.

Full text of the recommendation

Amendments to the Annexes to the Directive:

Directive 2003/101/EC [Official Journal L 286 of 04.11.2003]

This Directive replaces Annexes I and II of the basic directive on 1 January 2004.

5) Follow-Up Work

On 23 January 1998, the Commission presented a proposal for a European Parliament and Council Directive amending Council Directive 92/109/EEC on the manufacture and the placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances [COM(98) 22 final – Official Journal C 108 of 07.04.1998].

Co-decision procedure (COD/1998/17)

First reading: on 20 November 1998, the European Parliament approved the Commission proposal subject to certain amendments. The Commission accepted most of these amendments.

The Commission presented an amended proposal on 28 April 1999. [COM(99) 202 final – Official Journal C 162 of 09.06.1999]

This proposal was withdrawn by the Commission and replaced by:

Proposal for a European Parliament and Council regulation on drug precursors [COM(2002) 494 final – Official Journal C 20 E of 28.01.2003].

This proposal aims to transform Directive 92/109/EEC into a Regulation, in order to simplify the legislation and make it more user-friendly both for economic operators and for the competent authorities in the Member States. The purpose of the new Regulation is to establish harmonised measures for controlling and monitoring certain chemical substances frequently used in the manufacture of illicit narcotic drugs. It contains rules on licensing, customer declarations and labelling. A monitoring procedure will prevent barriers to the free trade of these substances arising between Member States.

Co-decision procedure (COD/2002/0217)

On 26 February 2003, the Economic and Social Committee gave its opinion. [Official Journal C 95 of 23.04.2003]

On 11 March 2003, the European Parliament approved the Commission proposal subject to certain amendments. The Commission accepted some of these amendments.

On 19 May 2003, the Council reached a political agreement on its common position.

On 27 May 2003, la Commission adopted an amended proposal [COM(2003) 304 final – not yet published in the Official Journal].

On 29 September 2003, the Council adopted the common position [Official Journal L 277 E of 18.11.2003].

On 7 October 2003, the Commission stated its agreement with the Council’s common position.

The common position is currently before Parliament for its second reading.

Direction indicator lamps for motor vehicles with trailers

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Direction indicator lamps for motor vehicles with trailers

Outline of the Community (European Union) legislation about Direction indicator lamps for motor vehicles with trailers

Topics

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

Internal market > Motor vehicles > Technical harmonisation for motor vehicles

Direction indicator lamps for motor vehicles with trailers (until 2014)

Document or Iniciative

Council Directive 76/759/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to direction indicator lamps for motor vehicles and their trailers [See amendingacts].

Summary

Each Member State must grant component EC type-approval for any type of direction indicator lamp which satisfies the construction and testing requirements laid down in the Annexes to the Directive, and issue an EC component type-approval mark conforming to the model shown in the Annex to the Directive for each type. The Member State which has granted EC component type-approval must take the measures required in order to verify that production models conform to the approved type.

According to the system of granting approval set out in the Directive, Member States may not:

  • prohibit the placing on the market of direction indicator lamps on grounds relating to their construction or method of functioning if they bear the EC component type-approval mark;
  • refuse to grant EC type-approval or national type-approval of any vehicle on grounds relating to its direction indicator lamps if these bear the EC component type-approval mark and are fitted in accordance with the requirements laid down in Directive 76/756/EEC;
  • refuse or prohibit the sale, registration, entry into service or use of any vehicle on grounds relating to its direction indicator lamps if these bear the EC component type-approval mark and are fitted in accordance with the requirements laid down in Directive 76/756/EEC.

Nevertheless, a Member State may prohibit the placing on the market of direction indicator lamps bearing the EC component type-approval mark which consistently fail to conform to the approved type.

This Directive is repealed by Regulation (EC) No 661/2009 from 1 November 2014.

References

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

Directive 76/759/EC

30.7.1976

1.7.1977

OJ L 262 of 27.9.1976
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 1999/15/EC

2.5.1999

1.10.1999

OJ L 97 of 12.4.1999

The successive amendments and corrections to Directive 76/759/EC have been incorporated into the original text. This consolidated version  is for reference only.

Front fog lamps on motor vehicles

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Front fog lamps on motor vehicles

Outline of the Community (European Union) legislation about Front fog lamps on motor vehicles

Topics

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

Internal market > Motor vehicles > Technical harmonisation for motor vehicles

Front fog lamps on motor vehicles (until 2014)

Document or Iniciative

Council Directive 76/762/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to front fog lamps for motor vehicles and filament lamps for such lamps [See amending acts].

Summary

Each Member State must grant EC component type-approval for any type of front fog lamp which satisfies the construction and testing requirements laid down in the Annexes to the Directive. The Member State which has granted EC component type-approval must take the measures required in order to verify that production models conform to the approved type.

Member States must issue an EC component type-approval mark for each type of front fog lamp.

According to the system of granting approval set out in the Directive, Member States may not

  • prohibit the placing on the market of front fog lamps on grounds relating to their construction or method of functioning if they bear the EC component type-approval mark.
  • refuse to grant EC type-approval or national type-approval or prohibit the sale, registration, entry into service or use of any vehicle on grounds relating to front fog lamps if these bear the EC component type-approval mark and are fitted in accordance with the requirements laid down in Directive 76/756/EEC.

This Directive is repealed by Regulation (EC) No 661/2009 from 1 November 2014.

References

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

Directive 76/762/EEC

30.7.1976

1.7.1977

OJ L 262 of 27.9.1976
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 1999/18/EC

2.5.1999

1.10.1999

OJ L 97 of 12.4.1999

The successive amendments and corrections to Directive 76/762/EEC have been integrated into the original text. This consolidated version  is for reference only.

Conservation of wild birds

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Conservation of wild birds

Outline of the Community (European Union) legislation about Conservation of wild birds

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

Environment > Protection of nature and biodiversity

Conservation of wild birds

Document or Iniciative

Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds.

Summary

Member States of the European Union (EU) shall take measures to guarantee the conservation and govern the exploitation of wild birds naturally occurring in the European territory in order to maintain their population at a satisfactory level, or to adapt their population to that level.

Protection of habitats

The disappearance or deterioration of habitats represents a threat to the conservation of wild birds. Their protection is therefore essential.

To preserve, maintain or re-establish the biotopes and habitats of birds, Member States shall:

  • designate protected areas;
  • ensure the upkeep and management of habitats in accordance with ecological needs;
  • re-establish destroyed biotopes and create biotopes.

Special protection areas

Member States shall create special protection areas (SPAs) for threatened species of birds and for migratory birds (see Annex I). These areas are to be situated in the birds’ natural area of distribution and may include wintering and nesting grounds or staging posts along migration routes.

Member States shall pay particular attention to wetlands, which are in decline across Europe. They shall also create conditions favourable to the survival or reproduction of the species occurring in special protection areas. To this end, they shall take the necessary steps to avoid pollution or deterioration of habitats or any disturbances affecting the birds. They shall also assess the impact of projects likely to have a significant effect on the designated areas and take appropriate measures to avoid them.

The special protection areas (SPAs), together with the special areas of conservation (SACs) under the “Habitats” Directive (92/43/EEC), form the Natura 2000 European network of protected ecological sites.

Protection of wild birds

This Directive establishes a general system of protection for all species of wild birds occurring in European territory. It prohibits in particular:

  • deliberate destruction or capture of wild birds;
  • destruction of, or damage to, nests;
  • taking or keeping eggs even if empty;
  • practices which deliberately disturb the birds and which jeopardise the conservation of the species;
  • trade in and the keeping of live or dead species the hunting and capture of which are not permitted (this prohibition also applies to any parts or derivatives of a bird).

Under certain conditions, Member States may derogate from the provisions laid down for the protection of wild birds. However, the consequences of such derogations must not be incompatible with the conservation objectives specified in the Directive.

Member States must promote research for the purposes of the management, protection and wise exploitation of the species of wild birds occurring in the European territory (see Annex V).

Hunting

Species whose numbers, distribution and reproductive rate allow may be hunted. However, the practice of hunting must comply with certain principles:

  • the number of birds taken must not jeopardise the maintenance at a satisfactory level of the population of species which may be hunted;
  • species are not to be hunted during periods of breeding or rearing;
  • migratory species are not to be hunted during their return to their breeding grounds;
  • methods for the large-scale or non-selective killing of birds are prohibited (see Annex IV).

The list of species which may be hunted is provided in Annex II (Part A gives the list of species which may be hunted throughout the EU, and Part B the list of species which may be hunted in certain countries only).

Context

This Directive replaces Directive 79/409/EEC of 2 April 1979 (more commonly known as the “Birds” Directive), which was the oldest EU legislative text relating to nature. However, the modifications made are purely formal. The “Birds” Directive established for the first time a general system for the protection of all species of wild birds naturally occurring in the territory of the Union. It also recognises that wild birds, which include a large number of migratory species, are a shared heritage of the EU Member States and that their conservation, to be effective, requires cooperation on a global scale.

References

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

Directive 2009/147/EC

15.2.2010

–

OJ L 20 of 26.1.2010

Trade in seal products

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Trade in seal products

Outline of the Community (European Union) legislation about Trade in seal 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

Trade in seal products

Document or Iniciative

Regulation (EC) No 1007/2009 of the European Parliament and of the Council of 16 September 2009 on trade in seal products.

Summary

Following concerns expressed by citizens regarding seal hunting methods, this regulation harmonises existing national rules regarding the placing on the European Union (EU) market of seal products *.

The placing on the Union market of seal products is only allowed when they:

  • result from seal hunts traditionally conducted by Inuit * and other indigenous communities and contribute to their subsistence;
  • result from by-products of hunting that is regulated by national law, undertaken solely for the purpose of the sustainable management of marine resources. The placing on the market is only allowed on a non-profit basis.

The import of seal products for non-commercial reasons is allowed where it is of an occasional nature and consists exclusively of goods for the personal use of travellers or their families.

EU countries are responsible for laying down the rules on penalties for infringements of this regulation and must ensure an effective implementation of the applicable penalties.

Every four years EU countries must send a report to the Commission detailing the actions taken to implement this regulation.

Background

The regulation supplements existing EU legislation regarding the protection of seals, in particular Directive 83/129/EEC prohibiting the importation into EU countries of skins of certain seal pups.

Animal welfare protection is an objective pursued by the Commission and is the focus of a Protocol annexed to the EC Treaty (Protocol No 33), which is at the heart of the Action Plan on the Protection and Welfare of Animals for the period 2006-2010.

Key terms of the Act
  • Seal: specimens of all species of pinnipeds.
  • Seal product: all products, either processed or unprocessed, deriving or obtained from seals, including meat, oil, blubber, organs, raw fur skins and fur skins, tanned or dressed, including fur skins assembled in plates, crosses and similar forms as well as articles made from seal fur skins.
  • Inuit: indigenous members of the Inuit homeland, namely those arctic and subarctic areas where Inuit have aboriginal rights and interests, recognised by Inuit as being members of their people.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1007/2009

20.11.2009

–

OJ L 286 of 31.10.2009

Related Acts

Commission Regulation (EU) No 737/2010 of 10 August 2010 laying down detailed rules for the implementation of Regulation (EC) No 1007/2009 of the European Parliament and of the Council on trade in seal products [Official Journal L 216 of 17.8.2010].

Parallel imports of proprietary medicinal products

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Parallel imports of proprietary medicinal products

Outline of the Community (European Union) legislation about Parallel imports of proprietary medicinal 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

Parallel imports of proprietary medicinal products

Document or Iniciative

Commission Communication of 30 December 2003 on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted [COM(2003) 839 – Not published in the Official Journal].

Summary

The parallel import of a medicinal product involves importing the product into one Member State from another and then distributing it outside the distribution network set up by the manufacturer or his/her authorised distributor.

The Commission would emphasise that parallel imports are a lawful form of trade within the Internal Market based on the principle of the free movement of goods. In the pharmaceutical sector, parallel trade benefits from the divergence in prices set by national governments to control their health care expenditure. Whilst they are legal, parallel imports of medicinal products may be restricted if they constitute a risk to the protection of human health and life, and to the protection of industrial and commercial property.

This Communication aims to reaffirm the principle of free movement for the pharmaceutical sector and define the legal limits with respect to parallel imports.

Simplified procedure for the distribution licence

A parallel imported medicinal product may be distributed under a licence obtained through a simpler procedure than that for the initial marketing authorisation for the product, provided that the parallel sales do not pose a risk to public health. According to the Commission, this simplified procedure for parallel imports is justified by the fact that the product in question has already received a marketing authorisation on the basis of full technical information.

To qualify for the simplified procedure, the parallel imported medicinal product must satisfy two conditions. It must:

  • have been granted a marketing authorisation in the Member State of origin; and
  • be sufficiently similar to a product that has already received marketing authorisation in the Member State of destination.

The similarity between two pharmaceutical products is considered to be sufficient when the two products have been manufactured according to the same formulation, using the same active ingredient, and have the same therapeutic effects. A parallel imported medicinal product can also be distributed under the simplified procedure even if the similar product upon which its licence is based is no longer available on the market, provided that public health requirements are met.

Protection and exhaustion of industrial and commercial property rights

Industrial and commercial property rights in the pharmaceutical sector are essentially national in nature. The Commission considers it necessary to protect these, but also to prevent them from being misused in order to create monopolies. Protection is then superseded by the exhaustion of industrial and commercial property rights that constitute obstacles to intra-Community trade. As a general rule, a pharmaceutical patent is exhausted as soon as the product is marketed, which means that the manufacturer no longer has any rights over what happens to the product once it has been sold.

The Commission defines the right to the protection of industrial and commercial property in a restrictive way by recognising the manufacturer’s right to control use of the brand but not necessarily of the product. Whereas counterfeiting can do direct damage to the brand, the parallel import brings free competition into the pharmaceutical sector in accordance with the principles of the internal market. The manufacturer’s industrial and commercial property right cannot be used to prevent the parallel import of a medicinal product that has already been lawfully placed on the market in another Member State.

Protection of trademarks and repackaging

The Commission considers that the repackaging of a parallel imported medicinal product, either under the same or a different brand name, may be justified for reasons relating to language or size. In theory, repackaging can be contradictory to the industrial and commercial property rights that protect the trademark and its manufacturer. In practice, the Commission sets out five conditions under which the repackaging of a medicinal product does not infringe the rights of the proprietor of the trademark. The proprietor of the trademark may not therefore oppose the repackaging of a medicinal product when the following conditions have been met:

  • the use of the trade-mark right by the owner contributes to the artificial partitioning of the internal market;
  • the repackaging does not adversely affect the original condition of the product;
  • it is stated on the new packaging by whom the product has been manufactured and repackaged;
  • the presentation of the repackaged product is not such as to damage the reputation of the trademark and of its proprietor; and
  • the proprietor of the trademark receives written notice of the repackaging before the new product is put on sale.

The Commission emphasises that repackaging must be a necessity, and not just be motivated by commercial interests. For example, repackaging is not justified for a parallel imported product that may be put on sale in the Member State of destination simply by changing the labelling. In addition, the proprietor of the trademark may require that the importer supply a specimen of the repackaged medicinal product so that he/she can check the condition of the product and its presentation.

Background

In this Communication, the Commission updates a Communication from 1982 with the substantial Court of Justice case law adopted in this field. Since the failure of a Commission proposal on parallel imports in 1981, the EU institutions have not managed to come to any legislative agreement in this field.

Related Acts

Communication from the Commission of 6 May 1982 on parallel imports of proprietary medicinal products [   ] [Official Journal C 115 of 6 May 1982].

Communication from the Commission of 25 November 1988 on the  [COM(1998) 588 – Not published in the Official Journal].