REGULATION (EC) No 299/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 11 March 2008
amendingRegulation(EC)No396/2005onmaximumresiduelevelsofpestici desinoronfoodandfeed
of plant and animal origin, as regards the implementing powers conferred o n the Commission
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,
Having regard to the Treaty establishing the European Commu-
nity, and in particular Articles 37 and 152(4)(b) thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and
Social Committee (1),
After consulting the Committee of the Regions,ActinginaccordancewiththeprocedurelaiddowninArticle251
of the Treaty (
2),
Whereas:
(1)Regulation(EC)No396/2005oftheEuropeanParliament
andoftheCouncil(3)providesthatcertainmeasuresareto
be adopted in accordance with Council Decision1999/468/EC of 28 June 1999 laying down the proce-dures for the exercise of implementing powers conferredon the Commission (
4).
(2)Decision 1999/468/EC has been amended by Decision
2006/512/EC, which introduced the regulatory procedurewithscrutinyfortheadoptionofmeasuresofgeneralscopeand designed to amend non-essential elements of a basicinstrument adopted in accordance with the procedurereferred to in Article 251 of the Treaty, inter alia by delet-ing some of those elements or by supplementing theinstrument with new non-essential elements.(3)In accordance with the statement by the European Parlia-
ment, the Council and the Commission (5) concerning
Decision 2006/512/EC, for the regulatory procedure withscrutiny to be applicable to instruments adopted in accor-dance with the procedure referred to in Article 251 of theTreaty which are already in force, those instruments mustbe adjusted in accordance with the applicable procedures.
(4)TheCommissionshouldbeempoweredtodefinethescope
ofRegulation(EC)No396/2005andthecriterianecessaryfor the establishment of certain maximum residue levels(MRLs) of pesticides in or on food and feed of plant andanimal origin listed in its relevant annexes. Since thosemeasures are of general scope and are designed to amendnon-essential elements of Regulation (EC) No 396/2005,inter alia by supplementing it with new non-essential ele-ments,theymustbeadoptedinaccordancewiththeregu-latoryprocedurewithscrutinyprovidedforinArticle5aofDecision 1999/468/EC.
(5)On grounds of efficiency and in order to guarantee eco-
nomic operators a rapid decision-making process, whilstensuring a high level of consumer protection, the normaltime limits for the regulatory procedure with scrutinyshould be curtailed for the adoption of measures setting,including,implementing,modifyingordeletingMRLsandestablishing a list of active substances for which no MRLsare required, as well as a list of active substance/productcombinations where active substances are used as fumi-gant for post-harvest treatment.
(6)When, on imperative grounds of urgency, and in particu-
larwherearisktohumanoranimalhealthexists,thenor-mal time limits for the regulatory procedure with scrutinycannot be complied with, the Commission should be ableto apply the urgency procedure provided for inArticle5a(6)ofDecision1999/468/ECfortheadoptionofmeasures setting, including, implementing, modifying ordeleting MRLs.
(7)Regulation (EC) No 396/2005 should therefore be
amended accordingly,(1) OJ C 161, 13.7.2007, p. 45.
(2) Opinion of the European Parliament of 29 November 2007 (not yet
published in the Official Journal) and Council Decision of 3 March2008.
(
3) OJ L 70, 16.3.2005, p. 1. Regulation as amended by Commission
Regulation (EC) No 178/2006 (OJ L 29, 2.2.2006, p. 3).
(4) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision
2006/512/EC (OJ L 200, 22.7.2006, p. 11). (5) OJ C 255, 21.10.2006, p. 1.9.4.2008 EN Official Journal of the European Union L 97/67HAVE ADOPTED THIS REGULATION:
Article 1
Amendments
Regulation (EC) No 396/2005 is hereby amended as follows:1. Article 4(1) shall be replaced by the following:
‘1. Theproducts,productgroupsand/orpartsofproducts
referred to in Article 2(1) to which harmonised MRLs shallapply shall be defined in and covered by Annex I. That mea-sure,designedtoamendnon-essentialelementsofthisRegu-lation, shall be adopted in accordance with the regulatoryprocedure with scrutiny referred to in Article 45(3). Annex Ishall include all products for which MRLs are set, as well asthe other products for which it is appropriate to apply har-monisedMRLs,inparticularinviewoftheirrelevanceinthediet of consumers or in trade. Products shall be grouped insuch a way that MRLs may as far as possible be set for agroup of similar or related products.’;
2. Article 5(1) shall be replaced by the following:
‘1. Active substances of plant protection products evalu-
ated under Directive 91/414/EEC for which no MRLs arerequiredshallbedefinedandlistedinAnnexIVtothisRegu-lation,takingintoaccounttheusesofthoseactivesubstancesand the matters referred to in points (a), (c) and (d) ofArticle 14(2). Those measures, designed to amend non-essential elements of this Regulation, shall be adopted inaccordance with the regulatory procedure with scrutinyreferred to in Article 45(4).’;
3. Article 8(2) shall be replaced by the following:
‘2. Applicationsshallbeevaluatedinaccordancewiththe
relevant provisions of the Uniform Principles for the Evalu-ation and Authorisation of Plant Protection Products set outin Annex VI to Directive 91/414/EEC or specific evaluationprinciples to be laid down in a Commission regulation. Thatregulation,designedtoamendnon-essentialelementsofthisRegulation by supplementing it, shall be adopted in accor-dancewiththeregulatoryprocedurewithscrutinyreferredtoin Article 45(3).’;
4. Article 14(1) shall be replaced by the following:
‘1. Upon receipt of the opinion of the Authority and tak-
ing account of that opinion, one of the following shall beprepared by the Commission without delay and at the latestwithin three months:(a) a regulation on the setting, modification or deletion of
an MRL. That regulation, designed to amend non-essentialelementsofthisRegulation,shallbeadoptedinaccordance with the regulatory procedure with scrutinyreferred to in Article 45(4). On imperative grounds ofurgency, the Commission may have recourse to theurgency procedure referred to in Article 45(5) in orderto ensure a high level of consumer protection;
(b) a decision rejecting the application, which shall be
adopted in accordance with the regulatory procedurereferred to in Article 45(2).’;
5. Article 15(2) shall be replaced by the following:
‘2. WhereatemporaryMRLissetasprovidedforinpara-
graph 1(b), it shall be deleted from Annex III by a regulationone year after the date of the inclusion or non-inclusion inAnnexItoDirective91/414/EECoftheactivesubstancecon-cerned.Thatregulation,designedtoamendnon-essentialele-mentsofthisRegulation,shallbeadoptedinaccordancewiththe regulatory procedure with scrutiny referred to inArticle 45(4). On imperative grounds of urgency, the Com-missionmayhaverecoursetotheurgencyprocedurereferredtoinArticle45(5)inordertoensureahighlevelofconsumerprotection.
However, where one or more Member States so request, the
temporary MRL may be maintained for an additional year
pendingconfirmationthatanyscientificstudiesnecessaryforsupportinganapplicationforsettingaMRLhavebeenunder-taken.Incaseswheresuchconfirmationisprovided,thetem-porary MRL shall be maintained for a further two years,provided that no unacceptable safety concerns for consum-ers have been identified.’;
6. Article 18 shall be replaced by the following:
‘Article 18
Compliance with MRLs
1. The products covered by Annex I shall not contain,
from the time they are placed on the market as food or feed,or fed to animals, any pesticide residue exceeding:
(a) theMRLsforthoseproductssetoutinAnnexesIIandIII;L 97/68
EN Official Journal of the European Union 9.4.2008(b) 0,01 mg/kg for those products for which no specific
MRL is set out in Annexes II or III, or for active sub-stances not listed in Annex IV unless different defaultvaluesarefixedforanactivesubstancewhiletakingintoaccount the routine analytical methods available. Suchdefault values shall be listed in Annex V. That measure,designed to amend non-essential elements of this Regu-lation, shall be adopted in accordance with the regula-toryprocedurewithscrutinyreferredtoinArticle45(4).On imperative grounds of urgency, the Commissionmay have recourse to the urgency procedure referred toin Article 45(5) in order to ensure a high level of con-sumer protection.
2. MemberStatesmaynotprohibitorimpedetheplacing
on the market or the feeding to food-producing animalswithintheirterritoriesoftheproductscoveredbyAnnexIonthe grounds that they contain pesticide residues providedthat:
(a) suchproductscomplywithparagraph1andArticle20;
or
(b) the active substance is listed in Annex IV.3. Bywayofderogationfromparagraph1,MemberStates
may authorise, further to a post-harvest treatment with afumigant on their own territory, residue levels for an activesubstance which exceed the limits specified in Annexes IIand III for a product covered by Annex I where the active
substance/productcombinationsarelistedinAnnexVIIpro-vided that:
(a) such products are not intended for immediate
consumption;
(b) appropriate controls are in place to ensure that such
products cannot be made available to the end user orconsumer,iftheyaresupplieddirectlytothelatter,untiltheresiduesnolongerexceedthemaximumlevelsspeci-fied in Annexes II or III;
(c) theotherMemberStatesandtheCommissionhavebeen
informed of the measures taken.
Measures designed to amend non-essential elements of this
Regulation and defining the active substance/product com-binations listed in Annex VII shall be adopted in accordancewith the regulatory procedure with scrutiny referred to inArticle 45(3).4. In exceptional circumstances, and in particular further
to the use of plant protection products in accordance withArticle 8(4) of Directive 91/414/EEC or pursuant to obliga-tions set out in Directive 2000/29/EC (
*), a Member State
may authorise the placing on the market and/or the feedingto animals within its territory of treated food or feed notcomplyingwithparagraph1,providedthatsuchfoodorfeeddoesnotconstituteanunacceptablerisk.SuchauthorisationsshallimmediatelybenotifiedtotheotherMemberStates,theCommission and the Authority, together with an appropri-ate risk assessment for consideration without undue delaywithaviewtosettingatemporaryMRLforaspecifiedperiodor taking any other necessary measure in relation to suchproducts. Those measures, designed to amend non-essentialelements of this Regulation by supplementing it, shall beadopted in accordance with the regulatory procedure withscrutiny referred to in Article 45(4). On imperative groundsof urgency, the Commission may have recourse to theurgency procedure referred to in Article 45(5) in order toensure a high level of consumer protection.
(*) CouncilDirective2000/29/ECof8May2000onprotec-
tive measures against the introduction into the Commu-nityoforganismsharmfultoplantsorplantproductsandagainst their spread within the Community (OJ L 169,10.7.2000, p. 1). Directive as last amended by Commis-sionDirective2007/41/EC(OJL169,29.6.2007,p.51).’;
7. Article 20(2) shall be replaced by the following:
‘2. Specific concentration or dilution factors for certain
processingand/ormixingoperationsorforcertainprocessedand/or composite products may be included in the list inAnnex VI. That measure, designed to amend non-essentialelements of this Regulation, shall be adopted in accordancewith the regulatory procedure with scrutiny referred to inArticle 45(3).’;
8. Article 21(1) shall be replaced by the following:
‘1. MRLs for products covered by Annex I shall be first
established and listed in Annex II, incorporating the MRLsprovided for under Directives 86/362/EEC, 86/363/EECand 90/642/EEC, taking into account the criteria listed inArticle14(2)ofthisRegulation.Thosemeasures,designedtoamend non-essential elements of this Regulation, shall beadopted in accordance with the regulatory procedure withscrutiny referred to in Article 45(3).’;
9. Article 22(1) shall be replaced by the following:
‘1. Temporary MRLs for active substances for which a
decision on inclusion or non-inclusion in Annex I to Direc-tive 91/414/EEC has not yet been taken shall be first estab-lished and listed in Annex III to this Regulation, unless9.4.2008
EN Official Journal of the European Union L 97/69already listed in Annex II, taking into account the informa-
tion provided by the Member States, where relevant the rea-soned opinion referred to in Article 24, the factors referredto in Article 14(2) and the following MRLs:
(a) remainingMRLsintheAnnextoDirective76/895/EEC;
and
(b) hitherto unharmonised national MRLs.Those measures, designed to amend non-essential elements
of this Regulation, shall be adopted in accordance with theregulatory procedure with scrutiny referred to inArticle 45(3).’;
10. Article 27(2) shall be replaced by the following:
‘2. Measuresdesignedtoamendnon-essentialelementsof
this Regulation by supplementing it and determining thesampling methods necessary for carrying out such controlsof pesticide residues in products other than those providedfor in Directive 2002/63/EC (
*) shall be adopted in accor-
dancewiththeregulatoryprocedurewithscrutinyreferredtoin Article 45(3) of this Regulation.
(*) CommissionDirective2002/63/ECof11July2002estab-
lishing Community methods of sampling for the official
control of pesticide residues in and on products of plantand animal origin and repealing Directive 79/700/EEC(OJ L 187, 16.7.2002, p. 30).’;
11. Article 45 shall be replaced by the following:
‘Article 45
Committee procedure
1. The Commission shall be assisted by the Standing
CommitteeontheFoodChainandAnimalHealthestablishedby Article 58 of Regulation (EC) No 178/2002.
2. Where reference is made to this paragraph, Articles 5
and7ofDecision1999/468/ECshallapply,havingregardtothe provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision
1999/468/EC shall be set at three months.
3. Wherereferenceismadetothisparagraph,Article5a(1)
to (4) and Article 7 of Decision 1999/468/EC shall apply,having regard to the provisions of Article 8 thereof.
4. Wherereferenceismadetothisparagraph,Article5a(1)
to(4)and(5)(b),andArticle7ofDecision1999/468/ECshallapply, having regard to the provisions of Article 8 thereof.ThetimelimitslaiddowninArticle5a(3)(c)and(4)(b)and(e)
of Decision 1999/468/EC shall be set at two months, onemonth and two months respectively.
5. Where reference is made to this paragraph,
Article 5a(1), (2), (4) and (6) and Article 7 of Decision1999/468/ECshallapply,havingregardtotheprovisionsofArticle 8 thereof.’;
12. Article 46 shall be replaced by the following:
‘Article 46
Implementing measures
1. Implementingmeasurestoensuretheuniformapplica-
tion of this Regulation, technical guidance documents toassistinitsapplicationanddetailedrulesconcerningthesci-entific data required for the setting of MRLs shall be estab-lishedormaybeamendedinaccordancewiththeregulatoryprocedure referred to in Article 45(2), taking into account,where appropriate, the opinion of the Authority.
2. Measuresdesignedtoamendnon-essentialelementsof
this Regulation and relating to the establishment or amend-ment of the dates referred to in Article 23, Article 29(2),Article30(2),Article31(1)andArticle32(5)shallbeadoptedin accordance with the regulatory procedure with scrutinyreferredtoinArticle45(3),takingintoaccount,whereappro-priate, the opinion of the Authority.’;
13. Article 49 shall be replaced by the following:
‘Article 49
Transitional measures
1. TherequirementsofChapterIIIshallnotapplytoprod-
ucts lawfully produced or imported into the Communitybefore the date referred to in the second paragraph ofArticle 50.
However, in order to ensure a high level of consumer pro-
tection, appropriate measures concerning those productsmay be taken. Those measures, designed to amend non-essential elements of this Regulation by supplementing it,shallbeadoptedinaccordancewiththeregulatoryprocedurewith scrutiny referred to in Article 45(5).
2. Where necessary to allow for the normal marketing,
processingandconsumptionofproducts,furthertransitionalmeasures may be laid down for the implementation ofL 97/70
EN Official Journal of the European Union 9.4.2008certainMRLsprovidedforinArticles15,16,21,22,and25.
Those measures, designed to amend non-essential elementsof this Regulation by supplementing it, and without preju-dicetotheobligationtoensureahighlevelofconsumerpro-tection, shall be adopted in accordance with the regulatoryprocedure with scrutiny referred to in Article 45(4).’Article 2
Entry into force
ThisRegulationshallenterintoforceonthedayfollowingthatof
its publication in the Official Journal of the European Union .
This Regulation shall be binding in its entirety and directly applicable i n all Member States.
Done at Strasbourg, 11 March 2008.
For the European Parliament
The President
H.-G. PÖTTERINGFor the Council
The President
J. LENARČIČ9.4.2008 EN Official Journal of the European Union L 97/71