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The placing of plant protection products on the market

Outline of the Community (European Union) legislation about The 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

The placing of plant protection products on the market (until June 2011)

The European Union has harmonised the conditions and procedures for authorising plant protection products so as to protect human health and the environment. It has also drawn up a list of authorised substances and a phased programme for evaluating substances already on the market.

Document or Iniciative

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [See Amending Acts].

Summary

The Directive lays down uniform rules on the evaluation, authorisation, placing on the market and control within the European Union of plant protection products * and the active substances * they contain.

Only plant protection products whose active substances are listed in Annex I to the Directive and that do not pose a risk to human or animal health or the environment when the product is used under normal conditions are authorised.

The procedure for evaluating and authorising plant protection products must comply with the uniform principles laid down in Annex VI to the Directive. These include:

general principles: the evaluation of data in the light of current knowledge, taking account of the particular conditions prevailing in the zone in which the product is to be used, etc;
specific principles concerning, among other things, efficacy, the absence of unacceptable effects on plants, the impact on human and animal health and on non-target species, distribution in and impact on the environment, etc.

The Directive stipulates the requirements for the dossier to be submitted for the inclusion of an active substance in the list of authorised substances (Annex II) and the requirements for the dossier to be submitted for the authorisation of a plant protection product (Annex III). These requirements concern, among other things, the identification of the substance or product, the identity of the manufacturer and applicant for authorisation, tests and analyses carried out by official or officially-recognized testing facilities or organisations, etc. Information held by the applicant or manufacturer may be protected by a confidentiality clause where it constitutes an industrial or commercial secret.

Authorisation is granted by the Member State on whose territory the product is placed on the market for the first time. It is valid for ten years and may be renewed. It can be withdrawn if the requirements are no longer fulfilled and can be amended if the development of scientific and technical knowledge requires.

To ensure the free circulation of products, the Directive provides for mutual recognition of authorisations granted by the Member States, provided that the plant health, agricultural and environmental conditions are comparable in the regions concerned. It does, however, contain a protective clause permitting Member States temporarily to restrict or prohibit the circulation of a product on their territory if it poses a risk to human or animal health or to the environment.

Every quarter, the Member States inform the Commission and the other Member States of all plant protection products authorised or withdrawn. In addition, every year Member States draw up and send to the Commission and the other Member States a list of products authorised on their territory.

Arrangements for provisional authorisation allow Member States, pending the Community’s decision to include a new active substance in the positive list, to authorise the plant protection product concerned for a maximum of three years if the dossier submitted for inclusion of the active substance and the dossier for the authorisation of the plant protection product are in order and if it is established that the active substance and the product pose no risk.

As regards active substances currently on the market, the Directive provides for an evaluation programme for these substances over a period of 12 years from the entry into force of the Directive. This programme was extended until March 2009. Since the end of 2003, the European Food Safety Authority has been responsible for assessing risks, while the Commission is still responsible for taking decisions concerning risk management.

The Directive also harmonises the rules on the labelling and packaging of plant protection products and the information they must bear, among other things, the name and designation of the product, the name and address of the holder of the authorisation, the quantity of each active substance, the directions for use, the dose for each authorised use and particulars of possible phytotoxicity, etc.

Context

This Directive is repealed with effect from 14 June 2011 by Regulation (EC) No 1107/2009 on the placing on the market of plant protection products.

Key terms used in the act
Plant protection products: these are products consisting of, or containing, active substances, safeners or synergists, intended for one of the following uses: protecting plants or plant products against all harmful organisms or preventing the action of such organisms, except if they are mainly designed for reasons of hygiene rather than protection of vegetables or vegetable products; influencing the life processes of plants, other than as a nutrient (e.g. plant growth regulators); preserving plant products, in so far as such substances or products are not subject to Community provisions on preservatives; destroying undesirable plants, or parts thereof, with the exception of algae; 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.

Key terms used in the act

Plant protection products: these are products consisting of, or containing, active substances, safeners or synergists, intended for one of the following uses:
- protecting plants or plant products against all harmful organisms or preventing the action of such organisms, except if they are mainly designed for reasons of hygiene rather than protection of vegetables or vegetable products;
- influencing the life processes of plants, other than as a nutrient (e.g. plant growth regulators);
- preserving plant products, in so far as such substances or products are not subject to Community provisions on preservatives;
- destroying undesirable plants, or parts thereof, with the exception of algae;
- 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
Directive 91/414//EEC	26.7.1991 (notification)	26.7.1993	OJ L 230 of 19.8.1991

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 806/2003	5.6.2003	–	OJ L 122 of 16.5.2003
Regulation (EC) No 396/2005	5.4.2005	–	OJ L 70 of 16.3.2005

AMENDMENT OF ANNEXES

Annex I – Active substances authorised for use in plant protection products:

Directive 2000/80/EC (lambda-cyhalothrin) [Official Journal L 309 of 9.12.2000];
Directive 2001/21/EC (amitrole, diquat, pyridate and thiabendazole) [Official Journal L 69 of 10.3.2001];
Directive 2001/28/EC (fenhexamid) [Official Journal L 113 of 24.4.2001];
Directive 2001/47/EC (paecilomyces fumosoroseus) [Official Journal L 175 of 28.6.2001];
Directive 2001/49/EC (flupyrsulfuron-methyl) [Official Journal L 176 of 29.6.2001];
Directive 2001/87/EC (acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen-ethyl) [Official Journal L 276 of 19.10.2001];
Directive 2001/99/EC (glyphosate and thifensulfuron-methyl) [Official Journal L 304 of 21.11.2001];
Directive 2001/103/EC (2,4-dichlorophenoxy acetic acid) [Official Journal L 313 of 30.11.2001];
Directive 2002/18/EC (isoproturon) [Official Journal L 55 of 26.2.2002];
Directive 2002/37/EC (ethofumesate) [Official Journal L 117 of 4.5.2002];
Directive 2002/48/EC (iprovalicarb, prosulfuron and sulfosulfuron) [Official Journal L 148 of 6.6.2002];
Directive 2002/64/EC (cinidon-ethyl, cyhalofop butyl, famoxadone, florasulam, metalaxyl-M and picolinafen) [Official Journal L 189 of 18.7.2002];
Directive 2002/81/EC (flumioxazine) [Official Journal L 276 of 12.10.2002];
Directive 2003/5/EC (deltamethrin) [Official Journal L 8 of 14.1.2003];
Directive 2003/23/EC (imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl and cyazofamid) [Official Journal L 81 of 28.3.2003];
Directive 2003/31/EC (2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide and pendimethalin) [Official Journal L 101 of 23.4.2003];
Directive 2003/39/EC (propineb and propyzamide) [Official Journal L 124 of 20.5.2003];
Directive 2003/68/EC (trifloxystrobin, carfentrazone ethyl, mesotrione, fenamidone and isoxaflutole) [Official Journal L 177 of 16.7.2003];
Directive 2003/70/EC (mecoprop, mecoprop-P and propiconazole) [Official Journal L 184 of 23.7.2003];
Directive 2003/79/EC (coniothyrium minitans) [Official Journal L 205 of 14.8.2003];
Directive 2003/81/EC (molinate, thiram and ziram) [Official Journal L 224 of 6.9.2003];
Directive 2003/84/EC (flurtamone, flufenacet, iodosulfuron, dimethenamid-p, picoxystrobin, fosthiazate and silthiofam) [Official Journal L 247 of 30.9.2003];
Directive 2003/112/EC (paraquat) [Official Journal L 321 of 6.12.2003];
Directive 2003/119/EC (mesosulfuron, propoxycarbazone and zoxamide) [Official Journal L 325 of 12.12.2003];
Directive 2004/20/EC (chlorpropham) [Official Journal L 70 of 9.3.2004];
Directive 2004/30/EC (benzoic acid, flazasulfuron and pyraclostrobin) [Official Journal L 77 of 13.3.2004];
Directive 2004/58/EC (alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham) [Official Journal L 120 of 24.4.2004];
Directive 2004/60/EC (quinoxyfen) [Official Journal L 120 of 24.4.2004];
Directive 2004/62/EC (mepanipyrim) [Official Journal L 125 of 28.4.2004];
Directive 2004/71/EC (Pseudomonas chlororaphis) [Official Journal L 127 of 29.4.2004];
Directive 2004/99/EC (acetamiprid and thiacloprid [Official Journal L 309 of 6.10.2004];
Directive 2005/2/EC (Ampelomyces quisqualis and Gliocladium catenulatum) [Official Journal L 20 of 22.1.2005];
Directive 2005/3/EC (imazosulfuron, laminarin, methoxyfenozide and s-metolachlor) [Official Journal L 20 of 22.1.2005];
Directive 2005/34/EC (etoxazole and tepraloxydim) [Official Journal L 125 of 18.5.2005];
Directive 2005/53/EC (chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl) [Official Journal L 241 of 17.9.2005];
Directive 2005/54/EC (tribenuron) [Official Journal L 244 of 20.9.2005];
Directive 2005/57/EC (MCPA and MCPB) [Official Journal L 246 of 22.9.2005];
Directive 2005/58/EC (bifenazate and milbemectin) [Official Journal L 246 of 22.9.2005];
Directive 2005/72/EC (chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, and metiram) [Official Journal L 279 of 22.10.2005];
Directive 2006/5/EC (warfarin) [Official Journal L 12 of 18.1.2006];
Directive 2006/6/EC (tolylfluanid) [Official Journal L 12 of 18.1.2006];
Directive 2006/10/EC (forchlorfenuron and indoxacarb) [Official Journal L 25 of 28.1.2006];
Directive 2006/19/EC (1-methylcyclopropene) [Official Journal L 44 of 15.2.2006];
Directive 2006/39/EC (clodinafop, pirimicarb, rimsulfuron, tolclofos-methyl and triticonazole) [Official Journal L 104 of 13.4.2006];
Directive 2006/41/EC (clothianidin and pethoxamid) [Official Journal L 187 of 8.7.2006];
Directive 2006/45/EC (propoxycarbazone) [Official Journal L 130 of 18.5.2006];
Directive 2006/64/EC (clopyralid, cyprodinil, fosetyl and trinexapac) [Official Journal L 206 of 27.7.2006];
Directive 2006/74/EC (dichlorprop-P, metconazole, pyrimethanil and triclopyr) [Official Journal L 235 of 30.8.2006];
Directive 2006/75/EC (dimoxystrobin) [Official Journal L 248 of 12.9.2006];
Directive 2006/85/EC (fenamiphos and ethephon) [Official Journal L 293 of 24.10.2006];
Directive 2006/131/EC (methamidophos) [Official Journal L 349 of 12.12.2006];
Directive 2006/132/EC (procymidone) [Official Journal L 349 of 12.12.2006];
Directive 2006/133/EC(flusilazole) [Official Journal L 349 of 12.12.2006];
Directive 2006/134/EC (fenarimol) [Official Journal L 349 of 12.12.2006];
Directive 2006/135/EC (carbendazim) [Official Journal L 349 of 12.12.2006];
Directive 2006/136/EC (dinocap) [Official Journal L 349 of 12.12.2006];
Directive 2007/5/EC (captan, folpet, formetanate and methiocarb) [Official Journal L 35 of 8.2.2007];
Directive 2007/6/EC (metrafenone, Bacillus subtilis , spinosad and thiamethoxam) [Official Journal L 43 of 15.2.2007];
Directive 2007/21/EC (azoxystrobin, imazalil, kresoxim-methyl, spiroxamin, azimsulfuron, prohexadion-calcium and fluroxypyr) [Official Journal L 97 of 12.4.2007];
Directive 2007/25/EC (dimethoate, dimethomorph, glufosinate, metribuzin, phosmet and propamocarb as active substances) [Official Journal L 106 of 24.4.2007];
Directive 2007/31/EC (fosthiazate) [Official Journal L 140 of 1.6.2007];
Directive 2007/50/EC (beflubutamid and Spodoptera exigua nuclear polyhedrosis virus) [Official Journal L 202 of 3.8.2007];
Directive 2007/52/EC (ethoprophos, pirimiphos-methyl and fipronil) [Official Journal L 214 of 17.8.2007];
Directive 2007/76/EC (fludioxonil, clomazone and prosulfocarb) [Official Journal L 337 of 21.12.2007];
Directive 2008/40/EC (amidosulfuron and nicosulfuron) [Official Journal L 87 of 29.3.2008];
Directive 2008/41/EC (chloridazon) [Official Journal L 89 of 1.4.2008];
Directive 2008/45/EC (metconazole) [Official Journal L 94 of 5.4.2008].
Directive 2008/66/EC (bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine) [Official Journal L 171 of 1.1.2008].
Directive 2008/69/EC (clofentezine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram and pyriproxyfen) [Official Journal L 172 of 2.7.2008];
Directive 2008/70/EC (tritosulfuron) [Official Journal L 185 of 12.7.2008];
Directive 2008/91/EC (diuron) [Official Journal L 262 of 1.10.2008];
Directive 2008/107/EC (abamectin, epoxiconazole, fenpropimorph, fenpyroximate and tralkoxydim) [Official Journal L 316 of 26.11.2008];
Directive 2008/108/EC (flutolanil, benfluralin, fluazinam, fuberidazole and mepiquat) [Official Journal L 317 of 27.11.2008];
Directive 2008/113/EC (several micro-organisms) [Official Journal L 330 of 9.12.2008];
Directive 2008/116/EC (aclonifen, imidacloprid and metazachlor) [Official Journal L 337 of 16.12.2008];
Directive 2008/125/EC (aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol) [Official Journal L 344 of 20.12.2008];
Directive 2008/127/EC (several active substances) [Official Journal L 344 of 20.12.2008];
Directive 2009/11/EC (bensulfuron, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate and tebufenpyrad) [Official Journal L 48 of 19.2.2009];
Directive 2009/25/EC (pyraclostrobin) [Official Journal L 91 of 3.4.2009];
Directive 2009/37/EC (chlormequat, copper compounds, propaquizafop, quizalofop-P, teflubenzuron and zeta-cypermethrin) [Official Journal L 104 of 24.4.2009];
Directive 2009/51/EC (nicosulfuron) [Official Journal L 127 of 26.5.2009];
Directive 2009/70/EC (difenacoum, didecyldimethylammonium chloride and sulphur) [Official Journal L 164 of 26.6.2009];
Directive 2009/77/EC (chlorsulfuron, cyromazine, dimethachlor, etofenprox, lufenuron, penconazole, tri-allate and triflusulfuron) [Official Journal L 172 of 2.7.2009];
Directive 2009/82/EC (tetraconazole) [Official Journal L 196 of 28.7.2009];
Directive 2009/115/EC (methomyl) [Official Journal L 228 of 1.9.2009];
Directive 2009/116/EC (paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3) [Official Journal L 237 of 9.9.2009];
Directive 2009/117/EC (paraffin oil CAS No 8042-47-5 [Official Journal L 237 of 9.9.2009];
Directive 2009/152/EC (carbendazim) [Official Journal L 314 of 1.12.2009];
Directive 2009/153/EC (hydrolysed proteins) [Official Journal L 314 of 1.12.2009];
Directive 2009/154/EC (cyflufenamid) [Official Journal L 314 of 1.12.2009];
Directive 2009/155/EC (metazachlor) [Official Journal L 314 of 1.12.2009];
Directive 2009/160/EU (2-phenylphenol) [Official Journal L 338 of 19.12.2009].

Annex II – Requirements for the dossier to be submitted for the inclusion of an active substance in Annex I:

Directive 93/71/EEC [Official Journal L 221 of 31.8.1993];
Directive 94/37/EC [Official Journal L 194 of 29.7.1994];
Directive 94/79/EC [Official Journal L 354 of 31.12.1994];
Directive 95/35/EC [Official Journal L 172 of 22.7.1995];
Directive 95/36/EC [Official Journal L 172 of 22.7.1995];
Directive 96/12/EC [Official Journal L 65 of 15.3.1996];
Directive 96/46/EC [Official Journal L 214 of 23.8.1996];
Directive 96/68/EC [Official Journal L 277 of 30.10.1996];
Directive 2001/36/EC [Official Journal L 164 of 20.6.2001].

Annex III – Requirements for the dossier to be submitted for the authorisation of a plant protection product:

Directive 93/71/EEC [Official Journal L 221 of 31.8.1993];
Directive 94/37/EC [Official Journal L 194 of 29.7.1994];
Directive 94/79/EC [Official Journal L 354 of 31.12.1994];
Directive 95/35/EC [Official Journal L 172 of 22.7.1995];
Directive 95/36/EC [Official Journal L 172 of 22.7.1995];
Directive 96/12/EC [Official Journal L 65 of 15.3.1996];
Directive 96/46/EC [Official Journal L 214 of 23.8.1996];
Directive 96/68/EC [Official Journal L 277 of 30.10.1996];
Directive 2001/36/EC [Official Journal L 164 of 20.6.2001].

Annex IV – Risk phrases:

Directive 2006/104/EC [Official Journal L 363 of 20.12.2006].

Annex V – Safety phrases:

Directive 2006/104/EC [Official Journal L 363 of 20.12.2006].

Annex VI – Uniform principles for the evaluation and authorisation of plant protection products:

Directive 97/57/EC [Official Journal L 265 of 27.9.1997];
Directive 2005/25/EC [Official Journal L 90 of 8.4.2005].

Related Acts

Programme for the evaluation of existing substances

Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I [Official Journal L 15 of 18.1.2008].
This Regulation completes the programme of work on the gradual examination of active substances on the market and lays down rules for the submission and evaluation of applications for inclusion in Annex I to Directive 91/414/EEC. Two procedures are established: a regular procedure involving verification by the Member State of dossiers on the active substance concerned, and an accelerated procedure which can be followed in the case of non-inclusion of the active substance.

Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC [Official Journal L 379 of 24.12.2004].

Commission Regulation (EC) No 1112/2002 of 20 June 2002 laying down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC [Official Journal L 168 of 27.6.2002].

Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC [Official Journal L 55 of 29.2.2000].

Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market [Official Journal L 366 of 15.12.1992].

This Regulation lays down detailed rules governing the relationship between industry, the Member States and the Commission for the implementation of the first phase of the programme, covering an initial series of 90 active substances.

Freedom of access to information

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Freedom of access to information

Outline of the Community (European Union) legislation about Freedom of access to information

Topics

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

Environment > General provisions

Freedom of access to information

Document or Iniciative

Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC.

Summary

Access to environmental information held by the public authorities is a prerequisite for stepping up the application and monitoring of Community environment law.

Disparities between the laws in force in the Member States concerning access to environmental information held by public authorities can create inequality within the Community as regards access to information and/or as regards conditions of competition.

‘Information relating to the environment’ means any available information in written, visual, aural or data-base form on the state of water, air, soil, fauna, flora, land and natural sites, and on activities or measures adversely affecting or likely so to affect these, and on activities or measures designed to protect these (including administrative measures and environmental management programmes).

The purpose of this Directive aims is to ensure that environmental information is systematically available and distributed to the public. That information includes at least:

international treaties, conventions and agreements and Community, national, regional and local legislation concerning the environment;
environment policies, programmes and plans;
reports on the state of the environment (to be published at least every four years);
data on activities affecting the environment;
environmental authorisations and agreements;
environmental impact studies and risk assessments.

Member States must ensure that public authorities make environmental information held by or for them available to any applicant, whether a natural or a legal person, on request and without the applicant having to state an interest. They must also ensure that:

officials assist the public in seeking access to information;
lists of public authorities are publicly accessible;
the right of access to environmental information can be effectively exercised.

Member States must ensure that all information held by the public authorities relating to imminent threats to human health or the environment is immediately distributed to the public likely to be affected.

Information must be made available to the applicant not later than one month after receipt of the request. If the volume and complexity of the information is such that this period cannot be complied with, a period of two months from the date of receipt of the request is to be allowed.

Access to public registers and lists and examination in situ of the information requested are free of charge. However, authorities may make a reasonable charge for supplying any environmental information.

Should information be requested in a specific format, the public authority must supply it in that format, unless it is already publicly available in another format or unless it is reasonable for the public authority to make it available in another format. In this case, the reasons for refusal to make it available in the requested format must be provided to the applicant within one month. Public authorities must endeavour to keep information in formats which are readily reproducible and accessible by electronic means, and ensure it is up-to-date, accurate and comparable.

Requests for information may be refused (a notification stating the reasons for the refusal being sent to the applicant within one month, in writing or electronically) where:

the public authority does not hold the requested information. Nonetheless, where it is aware that the information is held by another authority, it must inform the applicant accordingly;
the request is unreasonable;
the request is too general. However, the authority must ask the applicant to specify the request and help him to do so;
the requested information is in the course of completion;
the request concerns internal communications;
disclosure of the information would adversely affect the confidentiality of the proceedings of public authorities or of commercial or industrial information, public security or national defence, the course of justice, intellectual property rights, the confidentiality of personal data, the interests of the person who supplied the information on a voluntary basis, or the protection of the environment.

Where the information relates to emissions into the environment, Member States may not provide for a request to be refused by virtue of the exceptions relating to the confidentiality of the proceedings of public authorities, the confidentiality of commercial or industrial information, the confidentiality of personal data, the interests or the protection of any person who has supplied the requested information on a voluntary basis or the protection of the environment to which such information relates.

Member States must ensure that any applicant who considers that his request for information has not been handled in accordance with the provisions of the Directive has access to a procedure of administrative reconsideration or review. Any such procedure must be expeditious and inexpensive, and must be carried out by an independent body.

Not later than 14 August 2009, Member States must send the Commission a report on the application of the Directive. In turn, the Commission must report to the Council and the European Parliament and propose any appropriate revision of the Directive.

Background

On 25 June 1998 the Community signed a Convention on access to information, public participation in decision-making and access to justice in environmental matters (the Aarhus Convention). So that it can be ratified, Community legislation must be compatible with it. This Directive seeks this compatibility, extends the level of access to information set in Directive 90/313/EC and repeals this with effect from 14 February 2005.

References

Act	Entry into force – Date of expiry	Deadline for transposition in the Member States	Official Journal
Directive 2003/4/EC	14.02.2003	14.02.2005	OJ L 41 of 14.02.2003

Related Acts

Report – COM(2000) 400 final

Article 8 of Directive 90/313/EC states that, four years after 31 December 1992, the Member States must report to the Commission on the experience they have gained. In the light of this report, the Commission must present a report to the European Parliament and the Council, together with any proposals for revision it considers appropriate. The report is based on the experience gained by the Member States in implementing the Directive. It takes into account the reports drawn up by non-governmental organisations (NGOs) working in the environmental domain and developments in Community and international law. Complaints, petitions and parliamentary questions play a vital role in defining the main problems. These are the following:

definitions of information needing to be divulged and the public authorities and other bodies which are obliged to provide it;
the practical methods designed to guarantee effective access to the information;
exemptions to the obligations to provide access to information;
the requirement to reply;
deadlines applicable to obligations;
the requirement to justify any refusal;
the procedure for reviewing-examining decisions to reject requests for information;
charges;
the active provision of information.

The Commission has decided to present Directive 2003/4/EC in order to correct these errors and observe its obligations under the Aarhus Convention.

Uniform format for visas

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Uniform format for visas

Outline of the Community (European Union) legislation about Uniform format for visas

Topics

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

Justice freedom and security > Free movement of persons asylum and immigration

Uniform format for visas

Document or Iniciative

Council Regulation (EC) No 1683/95 of 29 May 1995 laying down a uniform format for visas [See amending acts].

Summary

A uniform format for visas

This Regulation lays down a uniform format for visas for all the Member States.

For the purposes of the Regulation, a “visa” means an authorisation given or a decision taken by a Member State, which is required for entry into its territory with a view to:

an intended stay in that Member State or in several Member States of no more than three months in all;
transit through the territory or airport transit zone of that Member State or several Member States.

The information contained in the uniform format visa must conform to:

the technical specifications set out in the Annex to the Regulation that lay down universally recognisable security features clearly visible to the naked eye;
the supplementary technical specifications, which aim to prevent counterfeiting and falsification of the visa and provide methods to fill in the visa.

If the supplementary technical specifications are to be kept secret, then they may only be communicated to:

the bodies responsible for printing the visas;
persons duly authorised by the Commission or a Member State.

Additional measures to ensure a high level of security were adopted by the Commission on 7 February 1996 and 27 December 2000.

Each Member State is to designate only one body as responsible for printing visas. It must communicate the name of this body to the Commission and the other Member States.

As provided by Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data, an individual to whom a visa has been issued may, where appropriate, request corrections be made with regard to their personal details entered onto the visa.

The Commission is assisted in its work on the uniform visa format by a Committee composed of representatives of the Member States and chaired by a Commission representative.

Member States may use the uniform visa format for purposes other than those mentioned above, as long as no confusion ensues with this uniform visa.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 1683/95	3.8.1995	–	OJ L 164 of 14.7.1995

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 334/2002	15.3.2002	–	OJ L 53 of 23.2.2002
Regulation (EC) No 856/2008	22.9.2008	–	OJ L 235 of 2.9.2008

Related Acts

Council Regulation (EC) No 333/2002 of 18 February 2002 on a uniform format for forms for affixing the visa issued by Member States to persons holding travel documents which are not recognised by the Member State drawing up the form [Official Journal L 53 of 23.2.2002].
This Regulation confines itself to a description of the uniform format in the interests of greater safety. A format for this form is annexed to the proposal. Technical specifications are established to ensure a certain level of security against counterfeiting, falsification and theft. They are secret, not published and made available only to the bodies designated by the Member States as responsible for the printing of the forms.
The uniform format for the form must be in use in the Member States no later than two years after the adoption of the above specifications.
The introduction of a new format does not affect the validity of authorisations already granted, unless the Member State concerned decides otherwise. With regard to the protection of personal data, Directive 95/46/EC has been complied with.

European statistics

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European statistics

Outline of the Community (European Union) legislation about European statistics

Topics

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

Internal market > Free movement of goods: general framework

European statistics

Document or Iniciative

Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (Text with relevance for the EEA and for Switzerland).

Summary

This Regulation aims to establish a legal framework for the development, production and dissemination of European statistics in compliance with the following principles:

professional independence;
impartiality;
objectivity;
reliability;
statistical confidentiality;
cost effectiveness.

How is statistical governance exercised?

Eurostat is the European authority responsible for developing, producing and disseminating European statistics. It coordinates the statistical activities of the institutions and bodies of the European Union (EU).

The national statistical institutes (NSIs) are designated by each Member State to coordinate all activities related to the development, production and dissemination of European statistics. They are a contact point for Eurostat.

The (ESS) is the result of a partnership between Eurostat and the NSIs, as well as other national authorities in each Member State.

This Regulation also establishes the European Statistical System Committee (ESS Committee), which shall be composed of representatives of the NSIs and chaired by Eurostat. The ESS Committee shall be consulted by the Commission on the following questions:

the development, production and dissemination of European statistics;
the European statistical programme;
issues concerning statistical confidentiality;
the further development of the Code of Practice.

The ESS shall cooperate closely with the European System of Central Banks (ESCB). It shall also be responsible for updating the European statistics Code of Practice. This Code of Practice aims at ensuring public trust in European statistics.

European statistics must be developed, produced and disseminated according to harmonised methods which, in particular, apply criteria of relevance, accuracy, accessibility and coherence.

How are European statistics produced?

European statistics are produced as part of the European statistical programme for a period of five years. This programme sets priorities as to information needs in relation to the activities of the European Union (EU).

Before finalising the statistical programme, the European Commission shall submit a draft to the ESS Committee.

Implementation of the European statistical programme shall be decided by:

the European Parliament and the Council;
the Commission;
a written agreement between the NSIs, other national authorities and Eurostat.

The Commission shall also submit an annual work programme to the ESS Committee for the following year, based on the European statistical programme.

How are European statistics disseminated?

European statistics shall be disseminated by Eurostat, the NSIs, and other national authorities. Such data may be disseminated in the form of a public file which shall nevertheless be anonymous.

Where the data have been transferred to Eurostat, the NSI or the national authority which provided the data must give its explicit approval before dissemination takes place.

What are the parameters of statistical confidentiality?

Confidential data shall only be accessed by Eurostat officials. Such data must be used exclusively for statistical purposes and must not be disclosed unlawfully.

However, there are exceptional cases in which statistical units may be disseminated, where:

specific conditions and modalities are determined by an act of the European Parliament and of the Council;
the statistical unit itself authorises the disclosure of its data.

Confidential data may be transmitted by an authority of the ESS to another authority as long as this act is recognised as being necessary to the development, production or dissemination of European statistics. The national rules of a Member State alone shall not be sufficient to justify such transmission.

NSIs, Eurostat and other national authorities may have access to sources of administrative data using their public administration system.

This Regulation repeals Regulation (EC, Euratom) No 1101/2008, Regulation (EC) No 322/97 and Decision 89/382/EEC.

Reference

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 223/2009	1.4.2009	–	OJ L 87 of 31.3.2009

Protection of personal data

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Protection of personal data

Outline of the Community (European Union) legislation about Protection of personal data

Topics

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

Information society > Data protection copyright and related rights

Protection of personal data

Document or Iniciative

European Parliament and Council Directive 95/46/EC of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [Official Journal L 281 of 23.11.1995] [See amending acts].

Summary

This Directive applies to data processed by automated means (e.g. a computer database of customers) and data contained in or intended to be part of non automated filing systems (traditional paper files).

It does not apply to the processing of data:

by a natural person in the course of purely personal or household activities;
in the course of an activity which falls outside the scope of Community law, such as operations concerning public security, defence or State security.

The Directive aims to protect the rights and freedoms of persons with respect to the processing of personal data by laying down guidelines determining when this processing is lawful. The guidelines relate to:

the quality of the data: personal data must be processed fairly and lawfully, and collected for specified, explicit and legitimate purposes. They must also be accurate and, where necessary, kept up to date;
the legitimacy of data processing: personal data may be processed only if the data subject has unambiguously given his/her consent or processing is necessary:
1. for the performance of a contract to which the data subject is party or;
2. for compliance with a legal obligation to which the controller is subject or;
3. in order to protect the vital interests of the data subject or;
4. for the performance of a task carried out in the public interest or;
5. for the purposes of the legitimate interests pursued by the controller;
special categories of processing: it is forbidden to process personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, trade-union membership, and the processing of data concerning health or sex life. This provision comes with certain qualifications concerning, for example, cases where processing is necessary to protect the vital interests of the data subject or for the purposes of preventive medicine and medical diagnosis;
information to be given to the data subject: the controller must provide the data subject from whom data are collected with certain information relating to himself/herself (the identity of the controller, the purposes of the processing, recipients of the data etc.);
the data subject’s right of access to data: every data subject should have the right to obtain from the controller:
1. confirmation as to whether or not data relating to him/her are being processed and communication of the data undergoing processing;
2. the rectification, erasure or blocking of data the processing of which does not comply with the provisions of this Directive in particular, either because of the incomplete or inaccurate nature of the data, and the notification of these changes to third parties to whom the data have been disclosed.
exemptions and restrictions: the scope of the principles relating to the quality of the data, information to be given to the data subject, right of access and the publicising of processing may be restricted in order to safeguard aspects such as national security, defence, public security, the prosecution of criminal offences, an important economic or financial interest of a Member State or of the European Union or the protection of the data subject;
the right to object to the processing of data: the data subject should have the right to object, on legitimate grounds, to the processing of data relating to him/her. He/she should also have the right to object, on request and free of charge, to the processing of personal data that the controller anticipates being processed for the purposes of direct marketing. He/she should finally be informed before personal data are disclosed to third parties for the purposes of direct marketing, and be expressly offered the right to object to such disclosures;
the confidentiality and security of processing: any person acting under the authority of the controller or of the processor, including the processor himself, who has access to personal data must not process them except on instructions from the controller. In addition, the controller must implement appropriate measures to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access;
the notification of processing to a supervisory authority: the controller must notify the national supervisory authority before carrying out any processing operation. Prior checks to determine specific risks to the rights and freedoms of data subjects are to be carried out by the supervisory authority following receipt of the notification. Measures are to be taken to ensure that processing operations are publicised and the supervisory authorities must keep a register of the processing operations notified.

Every person shall have the right to a judicial remedy for any breach of the rights guaranteed him by the national law applicable to the processing in question. In addition, any person who has suffered damage as a result of the unlawful processing of their personal data is entitled to receive compensation for the damage suffered.

Transfers of personal data from a Member State to a third country with an adequate level of protection are authorised. However, they may not be made to a third country which does not ensure this level of protection, except in the cases of the derogations listed.

The Directive aims to encourage the drawing up of national and Community codes of conduct intended to contribute to the proper implementation of the national and Community provisions.

Each Member State is to provide one or more independent public authorities responsible for monitoring the application within its territory of the provisions adopted by the Member States pursuant to the Directive.

A Working Party on the Protection of Individuals with regard to the Processing of Personal Data is set up, composed of representatives of the national supervisory authorities, representatives of the supervisory authorities of the Community institutions and bodies, and a representative of the Commission.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 95/46/EC	13.12.1995	24.10.1998	OJ L 281 of 23.11.1995

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

Successive amendments and corrections to Directive 95/46/EC have been incorporated in the basic text. This consolidated versionis for reference purpose only.

Related Acts

IMPLEMENTATION REPORT

Communication from the Commission to the European Parliament and the Council on the follow-up of the Work Programme for better implementation of the Data Protection Directive [COMM(2007) 87 final – Not published in the Official Journal].

This Communication examines the work done under the Work Programme for improved implementation of the Directive on data protection contained in the First report on the implementation of Directive 95/46/EC. The Commission highlights the fact that this has improved, has all Member States have now transposed the Directive. It emphasises that the Directive should not undergo any amendments at present.

It also notes that:

it will continue in its cooperation with the Member States and, if necessary, will launch official infringement proceedings;
it will prepare an interpretative communication regarding certain provisions in the Directive;
it will continue its implementation of the Work Programme
it will present EU-level sectoral legislation if there are major technological developments in a specific area;
it will continue cooperating with its external partners, in particular the US.

Report from the Commission of 15 May 2003 [COM(2003) 265 final – Not published in the Official Journal]
First report on the implementation of the Data Protection Directive (95/46/EC)

The report takes stock of the consultations carried out by the Commission to evaluate Directive 95/46/EC with governments, institutions, business and consumer associations, and individual citizens. The results of the consultations show that few contributors advocated a revision of the Directive. Furthermore, after consulting the Member States, the Commission noted the fact that a majority of them and, also, of the national supervisory authorities, did not consider it necessary to amend the Directive at present.

Despite the delays and gaps in implementation, the Directive has fulfilled its principal objective of removing barriers to the free movement of personal data between the Member States. The Commission also believes that the objective of ensuring a high level of protection in the Community has been achieved since the Directive has set out some of the highest standards of data protection in the world.

Other Internal Market policy objectives have, however, been less well served. The divergences in data protection legislation are still too great between Member States, and these disparities prevent multinational organisations from developing pan-European policies on data protection. The Commission will therefore do what is required to remedy this situation whilst hoping, wherever possible, that it will not be necessary to proceed by way of formal action.

With regard to the general level of compliance with data protection law in the EU, there are three main problems:

an under-resourced enforcement effort;
very patchy compliance by data controllers;
an apparently low level of knowledge of their rights among data subjects, which may be at the root of the previous phenomenon.

In order to ensure the better implementation of the Data Protection Directive, the Commission has adopted a work programme comprising a number of actions which need to be taken between the adoption of this report and the end of 2004. These actions are made up of the following initiatives:

discussions with Member States and data protection authorities on the changes needed to bring national legislation fully in line with the requirements of the Directive;
association of the candidate countries with efforts to achieve a better and more uniform implementation of the Directive;
improving the notification of all legal acts transposing the Directive;
simplification of the conditions for international transfers of data;
promotion of privacy enhancing technologies;
promotion of self-regulation and European Codes of Conducts.

PRIVACY AND ELECTRONIC COMMUNICATIONS DIRECTIVE

Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) [Official Journal L 201 of 31.07.2002]

This Directive was adopted in 2002 at the same time as a new legislative framework designed to regulate the electronic communications sector. It contains provisions on a number of more or less sensitive topics, such as the Member States keeping connection data for the purposes of police surveillance (the retention of data), the sending of unsolicited e-mail, the use of cookies and the inclusion of personal data in public directories.

STANDARD CONTRACTUAL CLAUSES FOR THE TRANSFER OF PERSONAL DATA TO THIRD COUNTRIES

Commission Decision 2004/915/EC of 27 December 2004 amending Decision 2001/497/EC as regards the introduction of an alternative set of standard contractual clauses for the transfer of personal data to third countries [Official Journal L 385 of 29.12.2004]

The European Commission has approved new standard contractual clauses which businesses can use to ensure adequate safeguards when personal data are transferred from the EU to third countries. These new clauses will be added to those which already exist under the Commission Decision of June 2001 (see below).

Commission Decision 2001/497/EC of 15 June 2001 on standard contractual clauses for the transfer of personal data to third countries under Directive 95/46/EC [Official Journal L 181 of 04.07.2001]

This Decision sets out standard contractual clauses to ensure an adequate level of protection of personal data transferred from the EU to third countries. The Decision requires Member States to recognise that companies or bodies which use these standard clauses in contracts relating to the transfer of personal data to third countries ensure an “adequate level of protection” of the data.

PROTECTION OF DATA BY THE COMMUNITY INSTITUTIONS AND BODIES

Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data [Official Journal L8 of 12.01.2001].

This Regulation aims at ensuring the protection of personal data within the institutions and bodies of the European Union. To this end:

it includes provisions which guarantee a high level of protection of personal data processed by the Community institutions and bodies; and
it provides for the establishment of an independent supervisory body to monitor the application of these provisions.