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

Archives

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.

ACT

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 It can be withdrawn if the requirements are no longer fulfilled and can be amended if the development of scientific and technical knowledge requires.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.

REFERENCES

ActEntry into forceDeadline for transposition in the Member StatesOfficial Journal

Directive 91/414//EEC

26.7.1991 (notification)

26.7.1993

OJ L 230 of 19.8.1991

Amending act(s)Entry into forceDeadline for transposition in the Member StatesOfficial 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].
See consolidated version

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.

Last updated: 28.01.2010

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