Council Decision of 25 September 2014 on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex II of the EEA Agreement (2014/675/EU)

DRAFT

DECISION OF THE EEA JOINT COMMITTEE No .../2014

of

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

(1) 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(1) is to be incorporated into the EEA Agreement.

(2) Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances(2), as corrected by OJ L 26, 28.1.2012, p. 38, is to be incorporated into the EEA Agreement.

(3) Commission Implementing Regulation (EU) No 541/2011 of 1 June 2011 amending Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances(3) is to be incorporated into the EEA Agreement.

(4) Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances(4) is to be incorporated into the EEA Agreement.

(5) Commission Regulation (EU) No 545/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products(5) is to be incorporated into the EEA Agreement.

(6) Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products(6) is to be incorporated into the EEA Agreement.

(7) Commission Regulation (EU) No 547/2011 of 8 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products(7) is to be incorporated into the EEA Agreement.

(8) Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market(8) is to be incorporated into the EEA Agreement.

(9) Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market(9) is to be incorporated into the EEA Agreement.

(10) Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market(10) is to be incorporated into the EEA Agreement.

(11) Regulation (EC) No 1107/2009 repeals Council Directives 79/117/EEC(11) and 91/414/EEC(12), which are incorporated into the EEA Agreement and which are consequently to be repealed under the EEA Agreement.

(12) Regulation (EU) No 283/2013 repeals Regulation (EU) No 544/2011, which is incorporated into the EEA Agreement and which is consequently to be repealed under the EEA Agreement.

(13) Regulation (EU) No 284/2013 repeals Regulation (EU) No 545/2011, which is incorporated into the EEA Agreement and which is consequently to be repealed under the EEA Agreement.

(14) Annex II to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1 U.K.

Chapter XV of Annex II to the EEA Agreement shall be amended as follows:

1.

The following is inserted after point 12zzo (Commission Decision 2013/204/EU):

‘13.

32009 R 1107: 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 (OJ L 309, 24.11.2009, p. 1).

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:

(a)

The EFTA States shall be free to limit access to their markets of plant protection products containing active substances approved in accordance with Council Directive 91/414/EEC or the Transitional measures in Article 80 of Regulation (EC) No 1107/2009.

(b)

The EFTA States, with the exception of Liechtenstein, may be “rapporteur Member State” and “co-rapporteur”.

(c)

The following shall be added to Article 18:

The allocation of evaluation of active substances to an EFTA State according to Article 18(f) is subject to consent from that State.’

(d)

The following shall be added to Articles 37(4) and 42(2):

For the EFTA States the time limit of 120 days shall at the earliest run from the date when the Act of approval of the active substances contained in the plant protection product is incorporated into the present Agreement.’

(e)

The following shall be added to Article 47(3):

For the EFTA States the time limit of 120 days shall at the earliest run from the date when the Act of approval of the active substances contained in the low-risk plant protection product is incorporated into the present Agreement.’

(f)

The following shall be added to Article 48:

The EFTA States may limit access to their markets of plant protection products containing genetically modified organisms, when measures to restrict or prohibit those organisms have been taken according to Article 23 of Directive 2001/18/EC, as adapted by this Agreement.’

(g)

Article 49 shall not apply to Liechtenstein.

(h)

Article 80(6) shall be replaced by the following:

Plant protection products authorized in accordance with national provisions applicable at the time of authorization may continue to be placed on the market until the plant protection product has been risk assessed according to Regulation (EU) No 1107/2009.’

(i)

The following shall be added to “Zone A — North” in Annex I:

Iceland, Norway’

(j)

The following shall be added to “Zone B — Centre” in Annex I:

Liechtenstein’

13a.

32011 R 0540: Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1), as corrected by OJ L 26, 28.1.2012, p. 38, as amended by:

• 32011 R 0541: Commission Implementing Regulation (EU) No 541/2011 of 1 June 2011 (OJ L 153, 11.6.2011, p. 187).

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:

The EFTA States shall be free to limit access to their markets of plant protection products containing active substances approved in accordance with Council Directive 91/414/EEC or the Transitional measures in Regulation (EC) No 1107/2009 Article 80.

13b.

32011 R 0544: Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (OJ L 155, 11.6.2011, p. 1).

13c.

32011 R 0545: Commission Regulation (EU) No 545/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products (OJ L 155, 11.6.2011, p. 67).

13d.

32011 R 0546: Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (OJ L 155, 11.6.2011, p. 127).

13e.

32011 R 0547: Commission Regulation (EU) No 547/2011 of 8 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labeling requirements for plant protection products (OJ L 155, 11.6.2011, p. 176).

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:

(a)

The following shall be added to the list under the title “RSh 1” in point 1.1. of Annex II:

IS: Eitrað í snertingu við augu.

NO: Giftig ved øyekontakt.’

(b)

The following shall be added to the list under the title “RSh 2” in point 1.1. of Annex II:

IS: Getur valdið ljósnæmingu.

NO: Kan gi overfølsomhet for sollys/UV-stråling.’

(c)

The following shall be added to the list under the title “RSh 3” in point 1.1. of Annex II:

IS: Efnið brennir húð og augu í snertingu við gufu og veldur kali í snertingu við vökva.

NO: Kontakt med damp virker etsende på hud og øyne, og kontakt med væske gir frostskade.’

(d)

The following shall be added to the list in point 1 of Annex III:

IS: Mengið ekki vatn með efninu eða íláti þess. (Hreinsið ekki búnað nálægt yfirborðsvatni/Koma skal í veg fyrir að mengun verði með afrennsli frá bæjarhlöðum og vegum.)

NO: Unngå forurensning av vannmiljøet med produktet eller emballasjen. (Ikke rengjør spredeutstyr nær overflatevann/unngå forurensning via avrenning fra gårdsplasser og veier).’

(e)

The following shall be added to the list under the title “SPo 1” under the title “Specific Provisions” in point 2.1 of Annex III:

IS: Ef efnið kemst í snertingu við húð skal fyrst hreinsa það af með þurrum klút og skola síðan húðina með miklu vatni.

NO: Etter kontakt med huden, fjern først produktet med en tørr klut, og vask deretter med mye vann.’

(f)

The following shall be added to the list under the title “SPo 2” under the title “Specific Provisions” in point 2.1 of Annex III:

IS: Þvoið allan hlífðarfatnað að lokinni notkun.

NO: Vask alt personlig verneutstyr etter bruk.’

(g)

The following shall be added to the list under the title “SPo 3” under the title “Specific Provisions” in point 2.1 of Annex III:

IS: Forðist innöndun reyks eftir að kveikt hefur verið í efninu og yfirgefið þegar í stað svæðið sem er til meðhöndlunar.

NO: Pust ikke inn røyken etter at produktet har antent, og forlat det behandlede området øyeblikkelig.’

(h)

The following shall be added to the list under the title “SPo 4” under the title “Specific Provisions” in point 2.1 of Annex III:

IS: Opna skal ílátið utanhús og við þurr skilyrði.

NO: Beholderen skal åpnes utendørs og under tørre forhold.’

(i)

The following shall be added to the list under the title “SPo 5” under the title “Specific Provisions” in point 2.1 of Annex III:

IS: Loftræsta skal úðuð svæði/gróðurhús (vandlega/eða í tilgreindan tíma/þar til úðinn hefur þornað) áður en farið er þangað inn aftur.

NO: De behandlede områder/veksthus ventileres (grundig/eller angivelse av tid/inntil produktet har tørket) før man oppholder seg der igjen.’

(j)

The following shall be added to the list under the title “SPe 1” in point 2.2 of Annex III:

IS: Til að vernda grunnvatn/jarðvegslífverur skal ekki nota þetta eða annað efni sem inniheldur (tilgreinið virkt efni eða flokk virkra efna eftir því sem við á) lengur eða oftar en (tilgreinið hversu lengi eða oft má nota efnið).

NO: For å beskytte (grunnvannet/jordlevende organismer) må dette produktet eller andre produkter som inneholder (angi navnet på virksomt stoff eller gruppe av virksomme stoffer) kun brukes/ikke brukes mer enn (angi tidsperiode eller antall behandlinger).’

(k)

The following shall be added to the list under the title “SPe 2” in point 2.2 of Annex III:

IS: Til að vernda grunnvatn/vatnalífverur skal ekki nota þetta efni (á tilgreinda jarðvegsgerð eða við tilgreindar aðstæður).

NO: For å beskytte (grunnvannet/vannlevende organismer) må dette produktet ikke brukes (på beskrevet jordtype eller under beskrevne forhold).’

(l)

The following shall be added to the list under the title “SPe 3” in point 2.2 of Annex III:

IS: Til að vernda vatnalífverur/plöntur utan markhóps/liðdýr utan markhóps/skordýr má ekki nota efnið nær óræktuðu landi/yfirborðsvatni en (tilgreind breidd svæðis sem er óheimilt að úða).

NO: For å beskytte (vannlevende organismer/viltlevende planter/insekter/leddyr) må dette produktet ikke brukes nærmere enn (angi avstand) fra (overflatevann/kantvegetasjon).’

(m)

The following shall be added to the list under the title “SPe 4” in point 2.2 of Annex III:

IS: Til að vernda vatnalífverur/plöntur utan markhóps má ekki nota efnið á malbikað, steinsteypt, hellulagðt eða malarborið yfirborð eða vegi (járnbrautarspor) eða önnur svæði þar sem hætt er við afrennsli út í umhverfið.

NO: For å beskytte (vannlevende organismer/viltlevende planter) må dette produktet ikke brukes på harde overflater som asfalterte, betong- brostein- eller gruslagte områder og veier/jernbane, eller på andre områder med stor risiko for avrenning.’

(n)

The following shall be added to the list under the title “SPe 5” in point 2.2 of Annex III:

IS: Til að vernda fugla/villt spendýr verður að gæta þess vandlega að efnið sé algerlega hulið jarðvegi; gætið þess sérstaklega að efnið sé hulið í endum raða.

NO: For å beskytte (fugler/ville pattedyr) skal produktet innblandes i jorden. Sørg også for at produktet er helt innblandet i enden av radene.’

(o)

The following shall be added to the list under the title “SPe 6” in point 2.2 of Annex III:

IS: Hreinsið upp allt efni, sem hefur farið til spillis, til að vernda fugla/villt spendýr.

NO: For å beskytte (fugler/ville pattedyr) skal alt søl fjernes.’

(p)

The following shall be added to the list under the title “SPe 7” in point 2.2 of Annex III:

IS: Óheimilt er að nota efnið á varptíma fugla.

NO: Må ikke brukes i fuglenes hekketid.’

(q)

The following shall be added to the list under the title “SPe 8” in point 2.2 of Annex III:

IS: Hættulegt frævandi skordýrum/Til að vernda býflugur og önnur frævandi skordýr er óheimilt að nota efnið á blómstrandi nytjaplöntur/Óheimilt er að nota efnið þar sem býflugur eru í fæðuleit/Fjarlægið býkúpur meðan meðhöndlun með efninu fer fram eða hyljið þær á meðan og í (tilgreinið tíma) að lokinni meðhöndlun/Óheimilt er að nota efnið ef blómstrandi illgresi er til staðar/Eyða skal illgresi áður en það blómgast/Óheimilt er að nota efnið fyrir (tilgreinið tíma).

NO: Farlig for bier./For å beskytte bier og andre pollinerende insekter må dette produkt ikke brukes mens kulturen blomstrer./Må ikke brukes der biene søker næring./Dekk til eller flytt bikuber i behandlingsperioden og i (nevn antall timer/dager) etter behandlingen./Må ikke brukes i nærheten av blomstrende ugress./Fjern ugresset før det blomstrer./Må ikke brukes før (tidspunkt).’

(r)

The following shall be added to the list in point 2.3 of Annex III:

IS: Til að koma í veg fyrir þolmyndun skal ekki nota þetta eða annað varnarefni sem inniheldur (tilgreinið virkt efni eða flokk virkra efna eftir því sem við á) oftar eða lengur en (tilgreinið hversu oft eða lengi má nota efnið).

NO: For å unngå utvikling av resistens må dette produkt eller andre produkter som inneholder (angi virksomt stoff eller gruppe av virksomme stoffer) kun brukes/ikke brukes mer enn (i tidsperioden eller antall ganger).’

(s)

The following shall be added to the list under the title “SPr 1” in point 2.4 of Annex III:

IS: Beitu skal komið fyrir þannig að ekki sé hætta á að önnur dýr komist í hana. Festa skal beituna tryggilega þannig að nagdýr geti ekki dregið hana í burtu.

NO: Produktet skal plasseres på en slik måte at risikoen for at andre dyr kan innta produktet minimeres. Pass på at produkt i blokkform ikke kan flyttes vekk av de gnagere som skal bekjempes.’

(t)

The following shall be added to the list under the title “SPr 2” in point 2.4 of Annex III:

IS: Auðkennið svæðið, sem meðhöndla á, meðan á meðhöndlun stendur. Varað skal við hættunni á að verða fyrir eitrun (beinni eða óbeinni) af völdum storkuvarans og tilgreina skal móteitrið við honum.

NO: Det behandlede området skal merkes i behandlingsperioden. Faren for forgiftning (primær eller sekundær) ved inntak av antikoaguleringsmidler, samt motgift, skal angis på oppslag.’

(u)

The following shall be added to the list under the title “SPr 3” in point 2.4 of Annex III:

IS: Hræ nagdýra skulu fjarlægð daglega af meðhöndlaða svæðinu meðan meðhöndlun stendur yfir. Ekki má setja hræin í opin sorpílát.

NO: Døde gnagere skal fjernes fra behandlingsområdet hver dag. Døde gnagere må ikke plasseres i åpne avfallsbeholdere.’

13f.

32012 R 0844: Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).’

2.

The text of point 13b (Commission Regulation (EU) No 544/2011) is replaced by the following:

‘32013 R 0283: Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 1).’

3.

The text of point 13c (Commission Regulation (EU) No 545/2011) is replaced by the following:

‘32013 R 0284: Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, p. 85).’

Article 2 U.K.

The text of points 6 (Council Directive 79/117/EEC) and 12a (Council Directive 91/414/EEC) in Chapter XV of Annex II to the EEA Agreement are deleted.

Article 3 U.K.

The texts of Regulations (EC) No 1107/2009, (EU) No 540/2011, as corrected by OJ L 26, 28.1.2012, p. 38, (EU) No 541/2011, (EU) No 544/2011, (EU) No 545/2011, (EU) No 546/2011, (EU) No 547/2011, (EU) No 844/2012, (EU) No 283/2013 and (EU) No 284/2013 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 4 U.K.

This Decision shall enter into force on […], provided that all the notifications under Article 103(1) of the EEA Agreement have been made(13).

For Liechtenstein this JCD shall enter into force on the same day or on the day of entry into force of the Agreement between Liechtenstein and Austria laying down the cooperation in the field of authorisation procedures for plant protection products and adjuvants according to Regulation (EC) No 1107/2009, whichever is the later.

Article 5 U.K.

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, ….

For the EEA Joint Committee

The President

The Secretaries

To the EEA Joint Committee

(1)

OJ L 309, 24.11.2009, p. 1.

(2)

OJ L 153, 11.6.2011, p. 1.

(3)

OJ L 153, 11.6.2011, p. 187.

(4)

OJ L 155, 11.6.2011, p. 1.

(5)

OJ L 155, 11.6.2011, p. 67.

(6)

OJ L 155, 11.6.2011, p. 127.

(7)

OJ L 155, 11.6.2011, p. 176.

(8)

OJ L 252, 19.9.2012, p. 26.

(9)

OJ L 93, 3.4.2013, p. 1.

(10)

OJ L 93, 3.4.2013, p. 85.

(11)

OJ L 33, 8.2.1979, p. 36.

(12)

OJ L 230, 19.8.1991, p. 1.

(13)

[No constitutional requirements indicated.] [Constitutional requirements indicated.]