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Supplementary protection certificate for medicinal products

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Supplementary protection certificate for medicinal products

Outline of the Community (European Union) legislation about Supplementary protection certificate for medicinal 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.

Internal market > Pharmaceutical and cosmetic products

Supplementary protection certificate for medicinal products

Document or Iniciative

Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (Text with EEA relevance).

Summary

The purpose of the supplementary protection certificate for medicinal products is to remedy the disparities and shortcomings in national patenting systems for pharmaceutical research. It aims in particular to guarantee sufficient protection for the development of medicinal products in the European Union (EU).

Indeed, the period between the filing of a patent application for a new medicinal product * and authorisation to place it on the market constitutes one of the factors which actually reduces the effective protection afforded by the patent and can compromise the amortisation of investment in research. The lack of sufficient protection can also lead research centres based in the Member States to relocate to countries offering better protection.

In order to also guarantee the free movement of medicinal products, the supplementary certificate for the protection of medicinal products also aims to prevent the development of too many disparities in national legislation.

The certificate is issued if the product for which it was requested, as a medicinal product and at the time when the application was filed in a Member State, meets the following conditions:

  • the product * is protected by a basic patent * in force;
  • the product, as a medicinal product, has been granted a marketing authorisation;
  • the product has not already been the subject of a certificate;
  • the marketing authorisation is the first authorisation to place the product on the market as a medicinal product.

Furthermore, the certificate applies to the product in the same way as the patent from which it benefits. The Regulation also specifies the arrangements relating to application for and granting of the certificate and likewise the conditions for lapse, invalidity and publicity of the certificate.

The certificate cannot be granted for a period exceeding five years. Furthermore, the duration of protection afforded by a patent and by the certificate cannot exceed 15 years overall for the holder’s first marketing authorisation.

This Regulation codifies and repeals Regulation (EEC) No 1768/92.

Key terms in the Act
  • Medicinal product: any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or animals.
  • Product: the active ingredient or combination of active ingredients of a medicinal product.
  • Basic patent: a patent which protects a product, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EEC) No 469/2009

6.7.2009

–

OJ L152 of 16.6.2009

Placing of plant protection products on the market

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Placing of plant protection products on the market

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

Topics

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

Food safety > Plant health checks

Placing of plant protection products on the market

Document or Iniciative

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

Summary

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Context

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

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

References

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

14.12.2009

–

OJ L 309 of 24.11.2009

Authorisation and supervision of medicinal products – European Medicines Agency

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Authorisation and supervision of medicinal products – European Medicines Agency

Outline of the Community (European Union) legislation about Authorisation and supervision of medicinal products – European Medicines Agency

Topics

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Internal market > Pharmaceutical and cosmetic products

Authorisation and supervision of medicinal products – European Medicines Agency

Document or Iniciative

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [See amending acts].

Summary

With this Regulation, the European Union (EU) develops and improves European procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human and veterinary use. The Regulation also provides the legal basis for the European Medicines Agency, which was established in 1993.

AUTHORISATION OF MEDICINAL PRODUCTS

Scope

No medicinal product appearing in the Annex may be placed on the European market without prior authorisation from the EU. The centralised authorisation procedure will be compulsory for:

  • medicinal products derived from biotechnology;
  • advanced therapy medicinal products;
  • orphan medicinal products;
  • medicinal products containing an entirely new active substance for which the therapeutic indication is the treatment of acquired immune deficiency syndrome, cancer, neurodegenerative disorder or diabetes, auto-immune diseases and other immune dysfunctions and viral diseases.

The centralised authorisation procedure will be optional for:

  • other medicinal products containing a new active substance;
  • medicinal products which constitute a therapeutic, scientific or technical innovation or are of interest at Community level.

Immunological veterinary medicinal products for the treatment of animal diseases that are subject to Community prophylactic measures may also be granted such authorisation. Finally, generic medical products of reference medicinal products authorised by the EU may be subject to a decentralised authorisation procedure, provided that the harmonisation achieved at European level is maintained.

Authorisation of medicinal products for human use

The Committee for Medicinal Products for Human Use is part of the European Medicines Agency. It is responsible for drawing up the opinion of the Agency on any matter concerning the evaluation of medicinal products for human use.

Each application for authorisation must be accompanied by the particulars and documents referred to in Directive 2001/83/EC on the Community code relating to medicinal products for human use, and by the fee payable to the Agency. It should also contain a statement to the effect that clinical trials carried out outside the European Union meet the principles of good clinical practice and the ethical requirements of Directive 2001/20/EC on good clinical practice in the conduct of clinical trials on medicinal products for human use.

Each authorisation decision must be taken on the basis of scientific criteria concerning the quality, safety and efficacy of the medicinal product concerned. These three criteria make it possible to assess the risk-benefit balance of all medicinal products. The Committee verifies first of all that conditions for granting a marketing authorisation are satisfied. If this is not the case, the applicant is informed forthwith and he/she may give notice to the Agency within fifteen days that he/she wishes to request a re-examination of the opinion.

In general, the Committee must give its opinion within 210 days after receipt of the application. This analysis may involve a test being conducted on the medicinal product, its starting materials or its intermediate products and a specific inspection of the manufacturing site of the medicinal product concerned.

Within 15 days after receipt of the opinion, the Commission prepares a draft of the decision on the application which may contain the marketing authorisation. If this draft decision is not in accordance with the opinion of the Agency, the Commission annexes an explanation of the reasons for the differences, which is forwarded to Member States and the applicant. The Commission takes a final decision following a procedure of consultation of the Member States (comitology) within 15 days of the end of the procedure.

After verification of the particulars and documents submitted, the marketing authorisation may be refused if:

  • the applicant has not properly or sufficiently demonstrated the quality, safety or efficacy of the medicinal product;
  • the particulars provided are incorrect.

At the time of authorisation, or once the marketing authorisation has been issued, the Agency may recommend that the Commission impose an obligation to carry out:

  • a post-authorisation safety study;
  • a post-authorisation efficacy study.

These obligations are contained in the authorisation and in the risk management system.

The marketing authorisation is valid for five years and may be renewed. Once it has been renewed, the marketing authorisation is valid for an unlimited period unless the Commission once again opts for a validity of five years.

Authorisation of medicinal products for veterinary use

The Committee for Medicinal Products for Veterinary Use is part of the Agency. It has sole responsibility for preparing the Agency’s opinions on all questions concerning the evaluation of veterinary medicinal products.

Most of the above considerations apply in this field, subject to adjustments relating to certain technical or scientific characteristics.

The marketing authorisation may be refused if:

  • the applicant has not properly or sufficiently demonstrated the quality, safety or efficacy of the medicinal product;
  • the product is presented for a use prohibited under European law;
  • the health and welfare of animals or consumer safety are not sufficiently taken into account in the case of zootechnical veterinary medicines and performance enhancers;
  • the withdrawal period indicated by the applicant is not long enough to ensure that foodstuffs obtained from treated animals do not contain residues which might constitute a health hazard for the consumer.

For both categories of medicinal products, if the products marketed are of major therapeutic interest, the applicant can request an accelerated assessment procedure.

The refusal of an EU marketing authorisation constitutes a prohibition on the placing on the market of the medicinal product throughout the EU. Any marketing authorisation which is not followed by the actual placing of the medicinal product on the market for three consecutive years ceases to be valid.

SUPERVISION OF MEDICINAL PRODUCTS (PHARMACOVIGILANCE)

Pharmacovigilance rules are necessary in order to protect public health and to prevent, detect and assess the undesirable effects of medicinal products for human use placed on the EU market, insofar as the safety profile of medicinal products can only be fully appreciated after products have been marketed. In the light of the knowledge obtained and following an assessment by the Commission of the EU pharmacovigilance system, it transpired that measures to improve the European pharmacovigilance system were required.

The Regulation provides for increased market surveillance by reinforcing monitoring procedures. When the medicinal product has been manufactured in the EU, the supervisory authorities are the competent authorities of the Member States which granted the manufacturing authorisation. In the case of medicinal products imported from third countries, the competent authorities are those that granted the import authorisation. These must inform the Committee for Medicinal Products and the Commission of all instances where the manufacturer or importer fails to fulfil the obligations laid down.

The holder of a marketing authorisation for a medicinal product for human or veterinary use is obliged to make any variations that may be required taking account of the manufacturing methods and of technical and scientific progress in accordance with Directives 2001/83/EC and 2001/82/EC.

The holder must also ensure that the medicinal product is manufactured and monitored according to generally accepted scientific methods. He/she must supply to the Agency, to the Commission and to the Member States any new information which might entail the variation of the particulars or documents they have obtained. He/she must also relay any prohibition or restriction imposed in countries in which the medicinal product is marketed, as well as any other information which might influence the evaluation of the benefits and risks of the medicinal product. The holder of the marketing authorisation must also forward the results of clinical trials or other studies. This information must be updated regularly on the basis of recent scientific knowledge.

When there are serious differences of opinion between Member States with respect to whether the holder of a marketing authorisation, a manufacturer or an importer satisfies the requirements set in Directives 2001/83/EC and 2001/82/EC, the Commission may request a new inspection of the marketing authorisation holder, the manufacturer or the importer.

Where urgent action is essential to protect human health or the environment, a Member State may suspend the use in its territory of an authorised medicinal product.

Risk management

The holders of marketing authorisations issued prior to 2 July 2012 are not obliged to implement a risk management system for each medicinal product.

However, the Agency may nevertheless impose upon the holder of a marketing authorisation an obligation to implement such a system if it detects risks that might modify the risk-benefit balance of an authorised medicinal product.

Obligations incumbent upon holders of marketing authorisations, Member States, the Agency and the Commission apply to safety notices concerning medicinal products for human use.

The Agency must draw up and update a list of medicinal products that are to be the subject of further monitoring. This list must give:

  • the name of and active substances contained in medicinal products authorised in the EU if such medicinal products contain a new active substance which, until 1 January 2011, was not contained in any medicinal product authorised in the Union;
  • the name of and active substances contained in any biological medicinal product authorised after 1 January 2011.

EudraVigilance database

The Agency has set up the EudraVigilance database, the aim of which is to collate pharmacovigilance information relating to medicinal products authorised in the EU and to make such information accessible to the competent authorities.

EudraVigilance collects information relating to the undesirable effects on humans arising following use, whether compliant or not, of medicinal products, or those which come to light during post-authorisation studies. On the basis of this information, the Agency prepares an annual report which is sent to the Commission, the European Parliament and the Council.

The Agency takes the following measures concerning medicinal products for human use that have been authorised by means of the centralised procedure:

  • monitoring the results of measures to minimise the risks outlined in risk management plans;
  • assessment of updates to risk management systems;
  • monitoring information contained in the EudraVigilance database.

Cooperation

The Agency collaborates with the World Health Organization (WHO) as regards pharmacovigilance, as well as with the European Monitoring Centre for Drugs and Drug Addiction.

It collaborates with the Member States on the international harmonisation and standardisation of technical measures related to pharmacovigilance.

PROVISIONS CONCERNING THE EUROPEAN MEDICINES AGENCY

The European Medicines Agency is made up of different committees, including the Committee for Medicinal Products for Human Use, the Pharmacovigilance Risk Assessment Advisory Committee, the Paediatric Committee, the Committee on Herbal Medicinal Products, the Committee for Advanced Therapies, a secretariat and a Management Board. Each Member State appoints one member and one alternate of the Management Board and one member and one alternate to the Committees. The members of each Committee may be accompanied by experts in specific scientific or technical fields.

The Agency is specifically responsible for:

  • providing the Member States and the EU institutions with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which are referred to it;
  • coordinating the scientific evaluation of the quality, safety and efficacy of medicinal products which are subject to European marketing authorisation procedures and the scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products;
  • coordinating the supervision of medicinal products for human use which have been authorised in the EU;
  • keeping, and transmitting on request, assessment reports and information on authorised medicinal products;
  • collecting and disseminating information on potential adverse reactions to medicinal products for human use authorised in the EU, by means of a database permanently accessible to all Member States;
  • assisting Member States with the rapid communication of information to health-care professionals;
  • creating a database on medicinal products which is accessible to the general public;
  • advising on the maximum limits for residues of veterinary medicinal products and biocidal products used in animal husbandry which may be accepted in foodstuffs of animal origin.

Each committee establishes a standing working party with the sole remit of providing scientific advice to businesses, particularly small and medium-sized enterprises (SMEs), during the research stage and when developing new therapies. The objective is to stimulate pharmaceutical research in Europe, and thus allow patients to benefit earlier from more effective medicinal products.

The Agency’s revenue consists of a contribution from the EU and fees paid by undertakings for obtaining and maintaining EU marketing authorisations and for other services provided by the Agency. SMEs may pay reduced fees, defer payment of the fee, or receive administrative assistance under certain conditions.

References

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

Regulation (EC) No 726/2004

20.5.2004

–

OJ L 136, 30.4.2004
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1901/2006

26.1.2007

–

OJ L 378, 27.12.2006

Regulation (EC) No 1394/2007

3.12.2007

–

OJ L 324, 10.12.2007

Regulation (EC) No 219/2009

20.4.2009

–

OJ L 87, 31.3.2009

Regulation (EC) No 470/2009

6.7.2009

–

OJ L 152, 16.6.2009

Regulation (EU) No 1235/2010

1.1.2011 (applicable from 2.7.2012)

–

OJ L 348, 31.12.2010

Subsequent amendments and corrections to Regulation (EC) No 726/2004 have been incorporated in the basic text. This consolidated version  has a purely documentary value”.

Related Acts

Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council [Official Journal L 155 of 15 June 2007].

This Regulation lays down rules concerning the application of financial penalties to the holders of marketing authorisations who infringe certain obligations. It provides for two types of financial penalties: fines and periodic penalty payments.

Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council [Official Journal L 92 of 30 March 2006].

Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises [Official Journal L 329 of 16 December 2005].

Appliances burning gaseous fuels

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Appliances burning gaseous fuels

Outline of the Community (European Union) legislation about Appliances burning gaseous fuels

Topics

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

Internal market > Single Market for Goods > Construction

Appliances burning gaseous fuels

Document or Iniciative

Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009 relating to appliances burning gaseous fuels (Text with EEA relevance).

Summary

This Directive defines the rules applying to the following gas appliances and fittings:

  • appliances burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing and having a normal water temperature not exceeding 105 °C;
  • safety equipment, such as in particular safety devices, controlling devices and regulating devices.

These appliances must be designed and built in such a way as to operate safely and present no danger to persons, domestic animals or property.

When placed on the market, all appliances must be accompanied by:

  • technical instructions for the installer, giving details of the type of gas and supply pressure used, the flow of fresh air required, as well as the conditions for the dispersal of combustion products;
  • instructions for use and servicing intended for the user which give the information required for safe installation;
  • warnings indicating the type of gas, the supply pressure and any restrictions on use.

Manufacturers must guarantee the safety of the properties of materials.

The manufacturer must lodge an application for type-examination with the notified body * including:

  • the manufacturer’s name and address;
  • a written declaration;
  • design documentation.

Where the application satisfies the criteria laid down by this Directive, the notified body must issue an EC type-examination certificate to the applicant.

EC surveillance ensures that the manufacturer duly fulfils the obligations arising out of the approved quality system.

The manufacturer may also make an EC declaration of conformity to type *.

The gas appliance or installation must include the following inscriptions:

  • the manufacturer’s name or identification symbol;
  • the trade name of the appliance;
  • the type of electrical supply used;
  • the appliance category;
  • the last two digits of the year in which the “CE” marking was affixed.

This Directive repeals Directive 90/396/EC.

Key terms of the Act
  • Notified body: provides conformity assessment services under the conditions laid down by directives. This is a service to manufacturers in the public interest;
  • EC declaration of conformity to type: product quality assurance, a notified body assesses and checks the manufacturer’s quality systems.

Reference

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

Directive 2009/142/EC

5.1.2010

–

OJ L 330 of 16.12.2009

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

Biocides

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Biocides

Outline of the Community (European Union) legislation about Biocides

Topics

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

Food safety > Contamination and environmental factors

Biocides (until 1 September 2013)

Document or Iniciative

Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market [See amending act(s)].

Summary

Scope

The Directive concerns:

  • the authorisation and placing on the market of biocidal products in the Member States;
  • the mutual recognition of authorisations within the Community;
  • the establishment at Community level of a list of active substances which may be used in biocidal products.

The Directive applies to biocidal products, i.e. non-agricultural pesticides as defined in Article 2 of the Directive. An exhaustive list of the products covered by this Directive is annexed below.

The Directive does not apply to products falling within the scope of the following legislative acts:

  • Directive 2001/83/EC (medicinal products for human use);
  • Directive 2001/82/EC (veterinary medicinal products);
  • Regulation (EC) No 726/2004 (European Medicines Agency);
  • Directive 90/385/EEC (active implantable medical devices)
  • Directive 93/42/EEC (medical devices);
  • Directive 98/79/EC (in vitro diagnostic medical devices);
  • Regulation (EC) No 1333/2008 (food additives)
  • Regulation (EC) No 1334/2008 (flavourings in foodstuffs);
  • Regulation (EC) No 1935/2004 (materials and articles intended to come into contact with foodstuffs);
  • Directive 90/167/EEC (medicated feedingstuffs);
  • Regulation (EC) No 767/2009 (feed);
  • Regulation (EC) No 1831/2003 (use of additives in animal nutrition);
  • Regulation (EC) No 1223/2009 (cosmetic products);
  • Regulation (EC) No 1107/2009 (plant protection products).

Obligations of the Member States

Member States must ensure the authorisation, classification, labelling, packaging and proper use of the biocidal products in line with this Directive. Proper use includes measures necessary to keep the use of biocidal products to a minimum as well as an obligation to ensure that their use in the workplace is in compliance with the directives on health and safety protection for workers. Member States must appoint one or more competent authorities responsible for complying with the obligations imposed on them under this Directive, including granting authorisations and receiving information relating to biocidal products so as to be able to meet any medical demand.

Each quarter Member States must inform the other Member States and the Commission of any biocidal products which have been registered and authorised within their territory or for which an authorisation or registration has been refused, modified, renewed or cancelled.

Every three years since 2003, Member States have submitted reports to the Commission in which they provide information on any poisonings involving biocidal products.

Principle of mutual recognition of authorisations

The authorisation system is based on the principle of mutual recognition of authorisations. Under this principle, a biocidal product that has already been authorised or registered in one Member State must be authorised in another Member State within 120 days or registered within 60 days of an application being received by the other Member State.

However, there are a number of derogations from mutual recognition:

  • The Member State may request that certain conditions relating to the classification, labelling and packaging of biocidal products be adapted under certain circumstances. These involve the quantity of the target species in the territory of the Member State, the degree of resistance of the target organism to the biocidal product and the circumstances under which it is used;
  • Where a Member State believes that a low-risk biocidal product which has been registered in another Member State does not comply with the definition set out in the Directive it may provisionally refuse to register it. In such cases it must notify the competent authority responsible for verifying the dossier;
  • Where a Member State believes a biocidal product authorised by another Member State does not meet the conditions for granting the authorisation and proposes to refuse the authorisation or registration it must notify the Commission, the other Member States and the applicant. The case will then be referred to the Standing Committee on Biocidal Products for a final decision which must be unanimously accepted;
  • Unless otherwise stated in the Treaty, Member States may refuse to grant mutual recognition of authorisations issued for types of products used against vermin, fish and birds, provided that such action is justifiable and does not frustrate the objectives of the Directive.

Conditions governing the granting of authorisations

It is compulsory to issue product marketing authorisation, subject to certain derogations in the case of low-risk products. The Member States may authorise a biocidal product only if:

  • its active substances are listed in the Annexes to the Directive and the requirements set out in the Annexes are met;
  • it is established that:
    • the biocidal product is sufficiently effective,
    • it has no unacceptable effects on the target organisms,
    • it has no unacceptable effects on human health or animal health or on surface water or groundwater,
    • it has no unacceptable effect on the environment;
  • the nature and quantity of its active substances can be determined according to the requirements listed in the Annexes to the Directive;
  • its physical and chemical properties have been deemed acceptable for purposes of appropriate use, storage and transport of the product.

A biocidal product classified as toxic, carcinogenic and mutagenic or toxic for reproduction is not authorised for marketing to the general public.

Authorisations may be reviewed at any time during the period for which they have been granted.

Placing on the market of active substances

An active substance for use in biocidal products may be placed on the market if:

  • a dossier has been submitted to a Member State accompanied by a declaration that the active substance is intended for inclusion in a biocidal product. This condition applies to active substances which did not have an authorisation to be placed on the market before 14 May 2000;
  • the active substance is classified, packaged and labelled in accordance with Directive 67/548/EEC which is applicable until 1 June 2015.

All active substances approved for inclusion in biocidal products are listed in Annex I or IA to the Directive. The maximum period during which a substance may be listed in the Annex is ten years.

Inclusion of a new active substance in the Annex

With a view to listing a new active substance in Annex I, IA or IB to the Directive, the Commission presents a proposal to the Standing Committee. The proposal is based on an evaluation of the substance carried out with the help of data supplied by the applicant.

Cancellation of an authorisation

An authorisation is cancelled if:

  • the active substance is no longer included in Annex I or IA to the Directive;
  • the conditions for obtaining the authorisation are no longer satisfied;
  • false particulars were supplied with the application for authorisation;
  • at the request of the authorisation holder.

Modification of an authorisation

An authorisation may be modified:

  • where a Member State considers that this is necessary to protect health and the environment;
  • at the request of the holder.

It is the responsibility of the holder of an authorisation for a biocidal product to pass on immediately to the competent authority any information of which he is aware concerning an active substance or a biocidal product containing it and which may affect continuing authorisation.

Procedure for requesting authorisation

An application for authorisation should come from the person initially responsible for placing a biocidal product on the market in a Member State and should be addressed to the competent authority in that Member State. In order to obtain the authorisation, the applicant must provide the following:

  • a dossier or letter of access concerning the biocidal product and containing the information specified in Annex IIB, IIIB or IVB depending on the type of biocidal product. The required information will contain, for example: the applicant’s name and address, the name and composition of the product, proposed uses, protective measures to be taken, among others. Dossiers for low-risk biocidal products are less detailed;
  • a dossier or letter of access for each active substance contained in the biocidal product and containing the information specified in Annexes IIA, IIIA and IVA.

The authorisation to place biocidal products on the market and entries of substances in Annex I, IA or IB are subject to the payment of a charge.

Member States may only use the information contained in the dossier accompanying the application for authorisation for the benefit of another applicant on certain conditions, one of which stipulates that the written agreement of the first applicant must be obtained.

Provisions applicable to a biocidal product that has already been authorised

Applicants for authorisation to place products on the market may use information provided by a previous applicant, in so far as the subsequent applicant can provide evidence that the product is similar and its active substances are the same as in the product previously authorised.

Before carrying out experiments involving vertebrate animals, an applicant for authorisation of a biocidal product must enquire of the competent authority of the Member State to which they intend to submit their application:

  • whether the biocidal product in question is similar to a biocidal product already authorised;
  • as to the name and address of the holder of the authorisation.

The applicant and holder or holders of former authorisations are encouraged to come to an agreement on the shared use of information to avoid duplicating the testing on vertebrate animals.

Exemptions

The Directive provides for the possibility of exemption from the requirements for placing biocidal products on the market. A Member State may temporarily authorise placing biocidal products on the market which do not comply with the provisions of the Directive for limited and controlled use if such measures appear necessary due to unforeseen danger not able to be contained by other means.

Role of the Commission

Following the adoption of the Directive, the Commission is to embark on a programme of work, systematically examining the risks associated with all active substances authorised for inclusion in biocidal products. The programme has been set up under a Regulation adopted by the Standing Committee on Biocidal Products, and will run for ten years. Its task is to examine all active substances already available on the market as of 14 May 2000 in the form of active substances for a biocidal product, with the exception of products used for purposes of research, science and product development.

Not more than two years prior to the completion of the programme of work, the Commission will send a progress report on the implementation of the programme to the European Parliament and the Council.

To further improve implementation of the Directive, the Commission must prepare technical guidelines which are to be published in the Official Journal of the European Communities.

Research and development

Experiments or tests carried out for the purposes of research or development involving the placing on the market of an unauthorised biocidal product or an active substance intended exclusively for use in a biocidal product are subject to several conditions, including an obligation to obtain authorisation from the competent authority if the tests are likely to have harmful effects on human or animal health or on the environment.

Classification, packaging and labelling

Biocidal products are classified, packaged and labelled in accordance with Directive 1999/45/EC on the classification, packaging and labelling of dangerous preparations which is applicable until 1 June 2015. However, in order to avoid any misunderstandings (confusion with foodstuffs or drinks, for example), the Directive lays down additional requirements with regard to the packaging and labelling of such products.

Safety measures

A system of specific information is introduced in order to enable professional and industrial users of biocidal products to take the necessary measures for the protection of the environment and health. This system must take the form of a data safety sheet provided by those responsible for placing the product on the market.

Confidentiality

The Directive allows the applicant to ask for certain sensitive information to be kept confidential from all persons other than the competent authorities and the Commission. Some information, however, (such as the name and address of the applicant, the physical and chemical properties of the biocidal product, etc.), cannot be included in this confidentiality clause.

Safeguard clause

The Directive allows the applicant to ask for certain sensitive information to be kept confidential from all persons other than the competent authorities and the Commission. Some information, however, (such as the name and address of the applicant, the physical and chemical properties of the biocidal product, etc.), cannot be included in this confidentiality clause.

Advertising

Marketing biocidal products is subject to certain conditions and must be in particular accompanied by wording which makes clear that the product should be used with care.

Comitology

The Commission is assisted by a Standing Committee on Biocidal Products. The Committee operates according to a regulatory procedure in the case of certain tasks, such as taking decisions to grant or withhold a prohibition (safeguard clause) or according to a management procedure in other cases, such as the listing of an active substance in the Annex and granting confidentiality.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Directive 98/8/EC

14.5.1998

13.5.2000

OJ L 123 of 24.4.1998
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1882/2003

20.11.2003

–

OJ L 284 of 31.10.2003

Directive 2007/47/EC

11.10.2007

21.12.2008

OJ L 247 of 21.9.2007

Directive 2008/31/EC

21.3.2008

–

OJ L 81 of 20.3.2008

Directive 2009/107/EC

26.10.2009

14.5.2010

JO L 262 du 6.10.2009

The successive amendments and corrections to Directive 98/8/EC have been incorporated into the basic text. This consolidated version  is for reference purpose only.

LAST AMENDMENTS TO THE ANNEXES

Annex I – List of active substances with requirements agreed at community level for inclusion in biocidal products
Directive 2011/10/EU [Official Journal L 34 of 9.2.2011];
Directive 2011/11/EU [Official Journal L 34 of 9.2.2011];
Directive 2011/12/EU [Official Journal L 34 of 9.2.2011];
Directive 2011/13/EU [Official Journal L 34 of 9.2.2011].

Related Acts

Evaluation of active substances

Directive 98/8/EC provides for an evaluation of all active substances already on the market as at 14 May 2000 in the form of active substances in biocidal products. The ten-year programme is divided into two phases: the first, which began in 2000, is concerned with the identification of the substances, and the second, which began in 2003, with their evaluation.

Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products [Official Journal L 228 of 8.9.2000].
The first phase of this Regulation adopted on 7 September 2000 aims to:

  • identify the relevant substances and specify which need to be evaluated with a view to their possible listing in Annex I, IA or IB to Directive 98/8/EC (active substances authorised for use in biocidal products);
  • identify the first priority list of active substances to be evaluated during the second phase of the programme (the existing active substances used in biocidal products of type 8 (wood preservatives) and type 14 (rodenticides)).

Producers should identify the active substances to the Commission not later than 18 months after the entry into force of this Regulation using the special software provided free of charge by the Commission. Should the producer or formulator wish to request the listing of an active substance in Annex I or IA to the Directive, notification rather than identification will be necessary. The producer or formulator is required to provide the Commission with the information specified in Annex II to the Regulation, using the special Commission software, within 18-months of the Regulation’s date of entry into force. The Commission, in cooperation with the Member States, will then decide whether to accept or reject the notification. If it is accepted, the notifier must provide all the data and information necessary evaluating the active substance with a view to its possible inclusion in the Annex to the Directive during the second phase of the review programme.

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market [Official Journal L 325 of 11.12.2007].
This Regulation replaces and repeals Regulation (EC) No 2032/2003 of 4 November 2003, which had been subject to successive amendments. These various amendments made it difficult to read, particularly the Annexes concerning lists of identified active substances (Annexes I and VII to Regulation EC No 2032/2003), notified substances (Annexes II, V and VIII), and identified but not notified active substances (Annex III).
Regulation (EC) No 1451/2007 thus rationalises these lists and consolidates their successive amendments:

  • by creating an Annexe I, corresponding to the list of existing active substances, i.e. substances that are known to have been placed on the market as active biocidal substances before 14 May 2000 (consolidation of Annexes I and VII to the previous Regulation);
  • by creating an Annexe II, corresponding to the list of active substances currently notified to the review programme, updated, indicating the name of the reporting Member State (consolidation of Annexes II, V and VIII to the previous Regulation);
  • by deleting the former Annex III to the previous Regulation EC No 2032/2003, since it was no longer of use.

Application of the legislation

Report from the Commission to the Council and the European Parliament of 8 October 2008 – Evaluation of the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market (submitted in accordance with Article 18 (5) of the Directive) and progress Report on the work programme referred to in Article 16(2) of the same Directive [COM(2008) 620 – Not published in the Official Journal].
The Directive set the foundations for improving the level of environmental and public health protection which is offered to European Union citizens in relation to biocidal products. During the five years prior to the effective start of the active substance review in 2004, the Commission, in cooperation with the Member States and industry, inventoried biocidal products on the market and put into place a structured procedure for the assessment and evaluation of the existing active substances.
The review programme will not be finalised by the date originally set, 14 May 2010, which also happens to be the date by which national rules for the placing on the market of biocidal products will cease to apply. Allowing the transitional period to elapse without completing the review programme for biocidal products,would mean that the harmonised rules of the Directive about product authorisation could not apply for all the biocidal products already on the market. If neither set of rules – harmonised or national – could apply, there would be a legal void with regard to the placing on the market of biocidal products. This could have negative effects on public health (if important biocidal products were withdrawn from the market) and would have severe adverse economic effects on all companies operating in the biocides sector.
Therefore, this Communication is accompanied by a proposal for the revision of the Directive which would extend the review programme, the transitional period, and certain provisions on data protection that accompany this period for an additional three years.

Another Normative about Biocides

Topics

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

Food safety > Plant health checks

Biocides

Document or Iniciative

Regulation (EC) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.

Summary

This Regulation applies to:

  • biocidal products *;
  • articles and materials treated * with biocidal products;
  • active substances.

A list of the products concerned can be found in Annex V to the Regulation.

Conditions for authorisation of biocidal products

For biocidal products, the following conditions must be met for authorisation:

  • the active substance are approved for the relevant product-type;
  • the biocidal product, when used as authorised, is sufficiently effective, has no unacceptable effects on the target organisms, on the health of humans or animals, or on the environment;
  • the physical and chemical properties of the product are considered acceptable with regard to the use and transport of the product;
  • where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product;
  • where nanomaterials are used in the product, the risk to human health, animal health and the environment has been assessed separately.

An active substance shall be approved for a maximum initial period of 10 years if at least one biocidal product containing that active substance may be expected to meet the above criteria.

National authorisation and mutual recognition

The Regulation provides for harmonised procedures for the authorisation of biocidal products in the EU. Once a first authorisation is granted by an EU country, the applicant can ask for the recognition of that authorisation by other EU countries. The authorisation shall be granted under identical terms and conditions.

Union authorisation

The centralised authorisation procedure will result in a Union authorisation which allows the industry to place biocidal products directly on the entire EU market without the need to obtain separate national authorisations or go through the mutual recognition procedure. This centralised authorisation is voluntary and if, for whatever reason, the applicant is not interested in a Union authorisation, he can instead apply for a national authorisation and, if appropriate, mutual recognition of that authorisation in other EU countries.

Simplified authorisation procedure

Certain biocidal products may be eligible for a simplified authorisation procedure, if the following conditions are met:

  • all the active substances contained in the biocide appear in and satisfy any restrictions in Annex I to this regulation;
  • the biocide does not contain any substance of concern or any nanomaterials;
  • the biocide is sufficiently effective;
  • the handling of the biocidal product and its intended use do not require personal protective equipment.

If the above conditions are met, applicants must submit applications to the European Chemicals Agency (ECHA), designating a competent authority to evaluate its application.

A biocidal product authorised by the above simplified procedure may be made available on the market in all EU countries without the need for mutual recognition. However, the authorisation holder must notify each EU country no later than 30 days before placing the product on the market within that country. The official language or languages of that country must be used on the product’s labelling, unless the country provides otherwise.

Treated articles

This Regulation extends the scope from previous legislation on biocides to now also cover articles which have been treated or which incorporate a biocidal product. Articles can only be treated with active substances which have been approved in the EU for that purpose. Manufacturers and importers of treated articles are required to label products when:

  • a claim is made that the treated article has biocidal properties;
  • the conditions of the approval of the active substance used to treat the article require specific labelling provisions to protect public health or the environment.
KEY TERMS USED IN THE ACT
  • Biocidal products: any substance or mixture to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
  • Treated article: any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.

References

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

Regulation (EC) No 528/2012

17.7.2012

–

OJ L 167 of 27.6.2012

Another Normative about Biocides

Topics

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

Food safety > Contamination and environmental factors

Biocides

Document or Iniciative

Regulation (EC) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.

Summary

This Regulation applies to:

  • biocidal products *;
  • articles and materials treated * with biocidal products;
  • active substances.

A list of the products concerned can be found in Annex V to the Regulation.

Conditions for authorisation of biocidal products

For biocidal products, the following conditions must be met for authorisation:

  • the active substance are approved for the relevant product-type;
  • the biocidal product, when used as authorised, is sufficiently effective, has no unacceptable effects on the target organisms, on the health of humans or animals, or on the environment;
  • the physical and chemical properties of the product are considered acceptable with regard to the use and transport of the product;
  • where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product;
  • where nanomaterials are used in the product, the risk to human health, animal health and the environment has been assessed separately.

An active substance shall be approved for a maximum initial period of 10 years if at least one biocidal product containing that active substance may be expected to meet the above criteria.

National authorisation and mutual recognition

The Regulation provides for harmonised procedures for the authorisation of biocidal products in the EU. Once a first authorisation is granted by an EU country, the applicant can ask for the recognition of that authorisation by other EU countries. The authorisation shall be granted under identical terms and conditions.

Union authorisation

The centralised authorisation procedure will result in a Union authorisation which allows the industry to place biocidal products directly on the entire EU market without the need to obtain separate national authorisations or go through the mutual recognition procedure. This centralised authorisation is voluntary and if, for whatever reason, the applicant is not interested in a Union authorisation, he can instead apply for a national authorisation and, if appropriate, mutual recognition of that authorisation in other EU countries.

Simplified authorisation procedure

Certain biocidal products may be eligible for a simplified authorisation procedure, if the following conditions are met:

  • all the active substances contained in the biocide appear in and satisfy any restrictions in Annex I to this regulation;
  • the biocide does not contain any substance of concern or any nanomaterials;
  • the biocide is sufficiently effective;
  • the handling of the biocidal product and its intended use do not require personal protective equipment.

If the above conditions are met, applicants must submit applications to the European Chemicals Agency (ECHA), designating a competent authority to evaluate its application.

A biocidal product authorised by the above simplified procedure may be made available on the market in all EU countries without the need for mutual recognition. However, the authorisation holder must notify each EU country no later than 30 days before placing the product on the market within that country. The official language or languages of that country must be used on the product’s labelling, unless the country provides otherwise.

Treated articles

This Regulation extends the scope from previous legislation on biocides to now also cover articles which have been treated or which incorporate a biocidal product. Articles can only be treated with active substances which have been approved in the EU for that purpose. Manufacturers and importers of treated articles are required to label products when:

  • a claim is made that the treated article has biocidal properties;
  • the conditions of the approval of the active substance used to treat the article require specific labelling provisions to protect public health or the environment.
KEY TERMS USED IN THE ACT
  • Biocidal products: any substance or mixture to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
  • Treated article: any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.

References

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

Regulation (EC) No 528/2012

17.7.2012

–

OJ L 167 of 27.6.2012