SOOVITUS TEISELE LUGEMISELE  Nõukogu ühine seisukoht eesmärgiga võtta vastu Euroopa Parlamendi ja nõukogu direktiiv, millega muudetakse 22. korda nõukogu direktiivi 76/769/EMÜ liikmesriikide õigus- ja haldusnormide ühtlustamise kohta seoses teatavate ohtlike ainete ja valmististe turustamise ja kasutamise piirangutega (ftalaadid mänguasjades ja lapsehooldusvahendites)

20.6.2005 - (5467/1/2005 – C6‑0092/2005 – 1999/0238(COD)) - ***II

Keskkonna-, rahvatervise- ja toiduohutuse komisjon
Raportöör: Antonios Trakatellis

EUROOPA PARLAMENDI ÕIGUSLOOMEGA SEOTUD RESOLUTSIOONI PROJEKT

nõukogu ühise seisukoha kohta eesmärgiga võtta vastu Euroopa Parlamendi ja nõukogu direktiiv, millega muudetakse 22. korda nõukogu direktiivi 76/769/EMÜ liikmesriikide õigus- ja haldusnormide ühtlustamise kohta seoses teatavate ohtlike ainete ja valmististe turustamise ja kasutamise piirangutega (ftalaadid mänguasjades ja lapsehooldusvahendites)

(5467/1/2005 – C6‑0092/2005 – 1999/0238(COD))

(Kaasotsustamismenetlus: teine lugemine)

Euroopa Parlament,

–   võttes arvesse nõukogu ühist seisukohta (5467/1/2005 – C6‑0092/2005);

–   võttes arvesse esimese lugemise seisukohta[1] Euroopa Parlamendile ja nõukogule esitatud komisjoni ettepaneku (KOM(1999)0577)[2] küsimuses;

–   võttes arvesse EÜ asutamislepingu artikli 251 lõiget 2;

–   võttes arvesse kodukorra artiklit 62;

–   võttes arvesse keskkonna-, rahvatervise- ja toiduohutuse komisjoni soovitust teisele lugemisele (A6‑0196/2005),

1.  kiidab ühise seisukoha muudetud kujul heaks;

2.  teeb presidendile ülesandeks edastada Euroopa Parlamendi seisukoht nõukogule ja komisjonile.

Nõukogu ühine seisukoht	Euroopa Parlamendi muudatusettepanekud
Muudatusettepanek 1 PEALKIRI
Euroopa Parlamendi ja nõukogu direktiiv, millega muudetakse 22. korda nõukogu direktiivi 76/769/EMÜ liikmesriikide õigus- ja haldusnormide ühtlustamise kohta seoses teatavate ohtlike ainete ja valmististe turustamise ja kasutamise piirangutega (ftalaadid mänguasjades ja lapsehooldusvahendites)	Euroopa Parlamendi ja nõukogu direktiiv, millega muudetakse 22. korda nõukogu direktiivi 76/769/EMÜ liikmesriikide õigus- ja haldusnormide ühtlustamise kohta seoses teatavate ohtlike ainete ja valmististe turustamise ja kasutamise piirangutega (ftalaadid) ning millega muudetakse nõukogu direktiivi 88/378/EMÜ mänguasjade ohutust käsitlevate liikmesriikide õigusaktide ühtlustamise kohta
Justification
Reinstatement of the title of the original proposal submitted by the Commission with the aim of including the provisions relating to the safety of toys (Directive 88/378/EEC) which were removed by the Council in the common position. In order to ensure a high level of protection for children's health, it is essential to set out the relevant warnings or indications to take precautions while using toys or childcare products containing certain phthalates in plasticised material which are intended for young children and could be put in the mouths of children aged less than three, even if they are not intended for that purpose.
Muudatusettepanek 2 PÕHJENDUS 3
(3) Teatud ftalaatide kasutamine plastifitseeritud materjalist valmistatud või plastifitseeritud materjalist valmistatud komponente sisaldavates mänguasjades ja lapsehooldusvahendites peaks olema keelatud, kuna teatud ftalaadid on või võivad olla ohtlikud laste tervisele.	(3) Teatud ftalaatide kasutamine plastifitseeritud materjalist valmistatud või plastifitseeritud materjalist valmistatud komponente sisaldavates mänguasjades ja lapsehooldusvahendites peaks olema keelatud, kuna teatud ftalaadid on või võivad olla ohtlikud laste tervisele. Mänguasjad ja lapsehooldusvahendid, eriti need, mis on mõeldud alla kolme aasta vanustele lastele ja mida saab suhu panna, ehkki need pole selleks ette nähtud, võivad teatud tingimustel väikelaste tervisele ohtlikud olla, kui need on valmistatud plastifitseeritud materjalist või neil on plastifitseeritud materjalist osi, mis sisaldavad teatud ftalaate. Tuleb märkida, et ftalaadid võivad imenduda lapse kehasse mitte üksnes siis, kui plastifitseeritud materjal pannakse suhu, vaid ka juhul, kui selline materjal satub ulatuslikku kontakti lapse nahaga. Ohtu peetakse suuremaks, kui laps on alla kolme aasta vanune.
Justification
Although the Council proposed a ban on the phthalates DEHP, DBP and BBP in concentrations of more than 0.1% in all toys and childcare articles, because they are classified, on the basis of assessment, as carcinogenic, mutagenic and reprotoxic, it exempted the substances DINP, DIDP and DNOP in toys and childcare articles intended for children over the age of three (the assessment has not been completed, despite the fact that there are indications of harmful effects on liver and thyroid cells in experimental animals). Children under three, however, can put toys and childcare products in their mouths, even if they are not intended for that purpose, and this is a potential health threat to those children. See Amendment 1 from Parliament's first reading.
Muudatusettepanek 3 PÕHJENDUS 3 A (uus)
	(3 a) Plastifitseeritud materjalist valmistatud või sellisest materjalist osi sisaldavate mänguasjade ja lapsehooldusvahendite puhul, millele on lisatud lõhnaaineid, on suurem oht, et laps need suhu paneb, kuigi need pole selleks mõeldud.
Justification
Toys and childcare articles made from plasticised material or which include parts made from plasticised material to which fragrances have been added increase the tendency of small children to put them in their mouths. Reinstatement of Amendment 2 from Parliament's first reading.
Muudatusettepanek 4 PÕHJENDUS 4 A (uus)
	(4 a) On olemas alternatiivsed plastifikaatorid, nagu näiteks atsetüültributüültsitraat ATBC, mille osas toksilisuse, ökotoksilisuse ja keskkonna teaduskomitee (SCTEE) arvamus toetab seisukohta, et selle kasutamine plastifikaatorina mänguasjades, mida väikelapsed suhu panevad, ei ole ohtlik.
Justification
Account should be taken of new scientific data and the new opinion of the SCTEE of 8 January 2004 which, following consultation with the Commission on ATBC, concluded that the data gaps were properly covered by the new data and that there is no safety concern with its use as a plasticiser for PVC toys mouthed by small children. See also Amendment 18 from Parliament's first reading.
Muudatusettepanek 5 PÕHJENDUS 8
(8) Seal, kus teaduslik hindamine ei võimalda ohtu piisava täpsusega määrata, tuleks rakendada ettevaatuspõhimõtet, et kindlustada tervisekaitse kõrge tase, eelkõige laste suhtes.	(8) Hädavajalik on, et seal, kus teaduslik hindamine ei võimalda ohtu piisava täpsusega määrata, tuleks ajutiselt rakendada ettevaatuspõhimõtet, et kindlustada tervisekaitse kõrge tase, eelkõige laste suhtes.
Muudatusettepanek 6 PÕHJENDUS 9
(9) Lapse arenev organism on eriti vastuvõtlik reproduktiivtoksilistele ainetele. Sel põhjusel tuleks vähendada nii palju kui võimalik laste kokkupuudet kõikide reaalselt välditavate allikatega, millest eritub neid aineid, eelkõige toodetega, mida lapsed panevad suhu.	(9) Lapse arenev organism on eriti vastuvõtlik reproduktiivtoksilistele ainetele. Sel põhjusel tuleks vähendada nii palju kui võimalik laste kokkupuudet kõikide reaalselt välditavate allikatega, millest eritub neid aineid, sealhulgas lastele mõeldud toodete või lapsehooldusvahenditega ja eelkõige toodetega, mida lapsed võivad suhu panna .
Justification
New amendment modifying a new recital in the common position.
Improving of the wording. The three reprotoxic PVC softeners are to be prohibited in all toys, irrespective of whether they are put into the mouth by children or not, as articles intended for children or for childcare should not contain such substances. It is therefore more appropriate to refer firstly to articles intended for children or childcare in general with regard to the need to reduce avoidable exposure as much as possible, and then to stress the possibility of these being put into the mouth by children.
Muudatusettepanek 7 PÕHJENDUS 10 A (uus)
	(10 a) DEHP, DBP ja BBP kahjulik toime alla kolme aasta vanuste laste tulevasele soojätkamisvõimele pole kaugeltki ainus viis, kuidas ftalaadid inimese tervist kahjustavad.
Muudatusettepanek 8 PÕHJENDUS 11
(11) Teaduslikud andmed DINP, DIDP ja DNOP kohta on kas puudulikud või vastuolulised, kuid ei saa välistada, et need kujutavad võimalikku ohtu, kui neid kasutada mänguasjades ja lapsehooldusvahendites, mida määratluse kohaselt toodetakse laste jaoks.	(11) Teaduslikud andmed DINP, DIDP ja DNOP kohta on kas puudulikud või vastuolulised, kuid ei saa välistada, et need kujutavad võimalikku ohtu, kui neid kasutada mänguasjades ja lapsehooldusvahendites, mida määratluse kohaselt toodetakse laste jaoks. Laste kokkupuudet kõikide praktiliselt välditavate allikatega, millest neid aineid eritub, eelkõige toodetega, mida lapsed võivad suhu panna, tuleks vähendada nii palju kui võimalik.‑{}‑ Sellisel juhul on mõistlik rakendada ettevaatusprintsiipi.
Justification
New amendment modifying a new recital in the common position.
Given the harmfulness of the substances, the high concentration with which they are to be used to soften PVC, the inevitable release of them from soft PVC, and the availability of substitutes, they represent an unnecessary risk.
Muudatusettepanek 9 PÕHJENDUS 12 A (uus)
	(12 a) Komisjon vaatab üle inimestele ohtu kujutada võivate plastifitseeritud materjalist valmistatud või selliseid osi sisaldavate toodete muu kasutamise, eelkõige nende kasutamise tervishoius.
Justification
Although the use of certain phthalates (e.g. DEHP) covers a very wide range of needs in the health sector, there is a need to review the medical appliances which are made of plasticised material or contain parts made of plasticised material and which may expose people to risks. Restrictions on the use and availability of such articles are considered necessary in cases where there are safer alternative solutions and where the restrictions do not have an adverse impact on medical treatment. Reinstatement of Amendment 5 from Parliament's first reading.
Muudatusettepanek 10 PÕHJENDUS 12 B (uus)
	(12 b) Tuleb sätestada nende DINP, DIDP või DNOPi sisaldavate lapsehooldustoodete asjakohane märgistamine, mida on lubatud käesoleva direktiivi alusel turule viia. Sarnane märgistamine tuleb ette näha ka nõukogu 3. mai 1988. aasta direktiivis mänguasjade ohutust käsitlevate liikmesriikide õigusaktide ühtlustamise kohta.
	______ 1 EÜT L 187, 16.07.88, lk 1. Direktiivi on viimati muudetud nõukogu direktiiviga 93/68/EMÜ, ELT L 220, 30.8.1993, lk 1.
Justification
While prohibiting various chemical substances in toys, Directive 88/378/EEC does not mention phalates. The Council recognises that the exposure of children to all sources of emissions of the substances in question which are possible to avoid in practical terms should be reduced, especially those from objects which come into contact with children's mouths. Although it proposed prohibiting DEHP, DBP and BBP in all toys and childcare articles, it restricted the ban in respect of DINP, DIDP and DNOP only to toys and childcare articles intended for children under three which could come into contact with the mouth. Given that children under the age of three can put in their mouths toys and childcare articles containing DINP, DIDP and DNOP which are intended for children from three to six, it is considered necessary to adopt labelling rules. See Amendment 3 from Parliament's first reading.
Muudatusettepanek 11 PÕHJENDUS 17
(17) Komisjon vaatab üle direktiivi 76/769/EMÜ I lisas loetletud ftalaatide kasutamise muudes toodetes, kui nõukogu 23. märtsi 1993. aasta määruse (EMÜ) nr 793/93 (olemasolevate ainete ohtlikkuse hindamise ja kontrolli kohta) alusel on lõpule viidud ohu hindamine.	(17) Komisjon vaatab üle direktiivi 76/769/EMÜ I lisas loetletud ftalaatide kasutamise muudes toodetes, kui nõukogu 23. märtsi 1993. aasta määruse (EMÜ) nr 793/93 (olemasolevate ainete ohtlikkuse hindamise ja kontrolli kohta) alusel on lõpule viidud ohu hindamine. Eelkõige kontrollib komisjon, kas ftalaatide kahjulik mõju võib lähtuda põrandakatetest, plastifitseeritud materjalist valmistatud või sellisest materjalist osi sisaldavatest toidupakenditest või ümbritsevast õhust ja vajadusel tellib uuringu, et teha kindlaks kõnealuse ohu suurus.
Justification
Modified reintroduction of amendments 4 and 5 from first reading.
The review of the use of phthalates in toys and childcare articles should be distinguished from the need to review other uses of phthalates. The Commission rightly foresees a review of the use of phthalates in other products, and this should be maintained. In line with the amendments from first reading, that should address in particular, but not be limited to, certain applications that are most likely to constitute an unnecessary risk.
Muudatusettepanek 12 PÕHJENDUS 17 A (uus)
	(17 a) Kui ftalaatide siirde mõõtmise meetod töötatakse välja ja pädev teaduskomitee kiidab heaks selle tehnika rakendamise praktikas, annab see komisjonile tugeva argumendi vaadata käesoleva direktiivi sätted ohuhinnangu ja pädeva teaduskomitee arvamuse alusel üle.
Justification
The subject remains open of developing a reliable method to establish the migration of phthalates and of assessing the related risks on the basis of new scientific data and the opinion of the competent scientific committee. Reinstatement of amendments 11 and 24 from Parliament’s first reading.
Muudatusettepanek 13 ARTIKLI 1 PUNKT 1 Artikli 1 lõike 3 punkt c (direktiiv 76/769/EÜ)
“c) “lapsehooldusvahend” – laste uinumise, rahustamise, toitmise ja imemise hõlbustamiseks ettenähtud toode.”	“c) “lapsehooldusvahend” – laste uinumise, rahustamise, hügieeni, toitmise, hammastumise ja imemise hõlbustamiseks ettenähtud toode.”

The aim of the amendment is to ensure that the new definition of childcare articles introduced in the Council common position is slightly extended in order to cover such products as changing tables and mats that are placed on changing tables.

Muudatusettepanek 14 ARTIKKEL 1 A (uus)
	Komisjon jälgib liikmesriigi mänguasjade ja lapsehooldusvahendite turu järelevalve ja kaitsmise eest vastutavate asutustega koostöös ning tootjate ja importijate vastavate organisatsioonidega konsulteerides ftalaatide ning teiste plastifikaatorainete kasutamist mänguasjades ja lapsehooldusvahendites. Hiljemalt ...* avaldab komisjon raporti ftalaatide ja teiste plastifikaatorite kasutamise kohta nendes toodetes. Selle raporti põhjal, arvestades uusimaid teaduslikke andmeid avastatud ainete kohta, ja kui see on põhjendatud, esitab komisjon kooskõlas asutamislepingu artikliga 251 vastavad õigusloomealased ettepanekud, et piirata kõnealuste ftalaatide ning plastifikaatorite kasutamist mänguasjades ja lapsehooldusvahendites.
	* 4 aasta jooksul alates käesoleva direktiivi jõustumisest.
Justification
New amendment building on the new recital 14 of the common position.
The monitoring requirements mentioned in recital 14 should also be included in the enacting terms of the directive. There are many more phthalates than the six addressed in this directive, and there are also plasticisers other than phthalates. Many of these may lead to harmful effects. To avoid the replacement of the six harmful phthalates with other harmful substances, Member States and the Commission should closely monitor the replacement of phthalates, and if necessary, the Commission should propose further legislative action.
Muudatusettepanek 15 ARTIKKEL 1 B (uus) IV lisa (direktiiv 88/378/EMÜ)
	Artikkel 1 b Direktiivi 88/378/EMÜ IV lisasse lisatakse järgmine punkt:
	“7. Mänguasjad, mis on valmistatud plastifitseeritud materjalist või mille komponendid koosnevad plastifitseeritud materjalist, mis sisaldavad direktiivi 76/769/EMÜ lisa punktis [XXa] nimetatud ftalaate, ning mida on lubatud viia turule vastavalt direktiivile 76/769/EMÜ.
	Mänguasja pakend peab kandma kergesti loetaval ja hästipüsival kujul järgmist hoiatust ja piktogrammi:
	“Sisaldab ftalaate – suhu mitte panna”.
	0-3
	Kui märgis osutub väiksemaks või suuremaks, tuleb ülaltoodud piktogrammi proportsioonid vastavalt säilitada.
Justification
Despite the ban on DEHP, DBP and BBP introduced by the Council, the question remains of protecting children’s health by applying the precautionary principle in the case of DINP, DIDP and DNOP in plasticised material used in toys intended for small children and which could be put in the mouths of children under three, although not intended for that purpose. Because of the uncertainty concerning the risk assessment, there is a need to provide for the possibility of information in the form of labelling. Reinstatement of amendment 6 from Parliament’s first reading.Muudatusettepanek 16 ARTIKKEL 2
Komisjon hindab …* ümber direktiivis 76/769/EMÜ, nii nagu seda on muudetud käesoleva direktiiviga, sätestatud meetmed, võttes arvesse uusi teaduslikke andmeid käesoleva direktiivi lisas kirjeldatud ainete ning nende asendajate kohta, ja kui see on põhjendatud, tuleb kõnealuseid meetmeid vastavalt muuta.	Komisjon hindab …* ümber direktiivis sätestatud meetmed, võttes arvesse uusi teaduslikke andmeid käesoleva direktiivi lisas kirjeldatud ainete ning nende asendajate kohta, ja kui see on põhjendatud, esitab kooskõlas asutamislepingu artikliga 251 vastavad õigusloomealased ettepanekud, et piirata kõnealuste ainete kasutamist.
* 4 aasta jooksul alates käesoleva direktiivi jõustumisest.	* 3 aasta jooksul alates käesoleva direktiivi jõustumisest.
Justification
Phthalates are used to plasticise a wide range of soft PVC products, which might pose similar risks as soft PVC toys. The Commission should evaluate these products to see whether further action is necessary.
The aim of the amendment, changing the four years proposed by the Council in the common position and the two years proposed by the EP to three years, is to speed up the collection of data and to ensure satisfactory time for risk evaluation, particularly in respect of the substances about which there is uncertainty, i.e. DINP, DIDP and DNOP. The amendment also seeks to approximate the positions of the two institutions with a view to the publication of the Directive. See also Amendment 8 from Parliament's first reading.
Muudatusettepanek 17 LISA I lisa punkt [XXa] (direktiiv 76/769/EMÜ)
Nõukogu ühine seisukoht
[XXa.] Järgmised ftalaadid (või muud CASi ja EINECSi numbritega ained, mis sisaldavad vastavat ainet): diisononüülftalaat (DINP)CASi nr 28553-12-0 ja 68515-48-0 Einecsi nr 249-079-5 ja 271-090-9 diisodetsüülftalaat (DIDP)CASi nr 26761-40-0 ja 68515-49-1 Einecsi nr 247-977-1 ja 271-091-4 di(-n-)oktüülftalaat (DNOP)CASi nr 117-84-0EINECSi nr 204-214-7 Alla kolmeaastastele lastele mõeldud mänguasjades ja lapsehooldusvahendites, mida nad saavad endale suhu panna, ei tohi kasutada ainena või valmistise koostisainena rohkem kui 0,1% plastifitseeritud materjali massist. Mänguasju ja lapsehooldusvahendeid, milles loetletud ftalaatide kontsentratsioon ületab eelmainitud piirväärtuse, ei ole lubatud turule viia.
Euroopa Parlamendi muudatusettepanek
[XXa.] Järgmised ftalaadid (või muud CASi ja EINECSi numbritega ained, mis sisaldavad vastavat ainet): diisononüülftalaat (DINP)CASi nr 28553-12-0 ja 68515-48-0 Einecsi nr 249-079-5 ja 271-090-9 diisodetsüülftalaat (DIDP)CASi nr 26761-40-0 ja 68515-49-1 Einecsi nr 247-977-1 ja 271-091-4 di(-n-)oktüülftalaat (DNOP)CASi nr 117-84-0EINECSi nr 204-214-7 Suhu panemiseks mõeldud mänguasjade ja lapsehooldusvahendite komponentides või mänguasjades ja lapsehooldusvahendites, mida lapsed saavad endale suhu panna, ei tohi kasutada ainena või valmistise koostisainena rohkem kui 0,1% plastifitseeritud materjali massist. Mänguasju ja lapsehooldusvahendeid, milles loetletud ftalaatide kontsentratsioon ületab eelmainitud piirväärtuse, ei ole lubatud turule viia. Komisjon töötab välja suunised aitamaks kaasa käesoleva direktiivi kohaldamisele, eelkõige sätete osas, mis piiravad teatud ainete kasutamist mänguasjade ja lapsehooldusvahendite puhul, kui "neid on lastel lubatud endale suhu panna". Mänguasjad ja lapsehooldusvahendid, mis sisaldavad kõnealuseid ftalaate ja mida on käesoleva direktiivi alusel lubatud turule viia, peavad kandma järgmist hoiatavat märgistust ja kergesti loetavat ning hästi püsivat piktogrammi: “Sisaldab ftalaate – suhu mitte panna”.                 0-3   Kui märgis osutub väiksemaks või suuremaks, tuleb ülaltoodud piktogrammi proportsioonid vastavalt säilitada. (1 f) Lõhnaaineid ei tohi lisada mänguasjadele ega lapsehooldusvahenditele, mis on valmistatud üht või mitut nimetatud ftalaati suuremas kui 0,1 % kontsentratsioonis sisaldavast plastifitseeritud materjalist või sisaldavad sellisest plastifitseeritud materjalist valmistatud komponente, kui laps võib neid mänguasju või hooldusvahendeid suhu panna. Mänguasju ega lapsehooldusvahendeid, mis sisaldavad lõhnaaineid ja nimetatud ftalaate suuremas kontsentratsioonis kui eelnenud lõikes öeldud, ei turustata.
Justification
Reinstatement of amendments 8, 9 and 16 from Parliament's first reading.
It is not appropriate to limit the restriction of DINP, DIDP and DNOP to toys for children under three. Putting toys into the mouth is not limited to a particular age. Even if it were, an arbitrary age limit ignores the reality of families with more than one child, where younger children will want to play with the toys of their elder siblings. These substances have been found to be harmful. They are used in high concentrations in toys, they are released from them, especially when put into the mouth, and alternative toys without harmful plasticisers are available. They should therefore be prohibited in all toys that can be put into the mouth.
For all other toys, provision must be made, on the basis of the precautionary principle, for the possibility of informing, by means of labelling, parents and adults who come into contact with children, of the presence of these substances.
Fragrant toys and childcare articles made of plasticised material or which include parts made from plasticised material increase the tendency of small children to put them in their mouth and, therefore, constitute a potential risk.

• [1]  EÜT C 121, 24.4.2001, lk 176.
• [2]  EÜT C 116, 26.4.2000, lk 14 E.

EXPLANATORY STATEMENT

1.   Background and remarks on procedure

On 10 November 1999, the Commission submitted to the European Parliament and the Council a proposal for a directive amending for the 22nd time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates) and amending Council Directive 88/378/EEC on the approximation of the laws of the Member States concerning the safety of toys (COM(1999) 577 - C5‑0276/1999 - 1999/0238 (COD))[1].

On the basis of the opinions of the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE), which the Commission also consulted pursuant to Article 9 of Council Directive 92/59/EEC on general product safety, the Commission decided on 7 December 1999 to prohibit the intentional use or placing on the market in quantities higher than 0.1% by weight of 6 phthalate esters, DEHP, DBP, BBP, DINP, DIDP and DNO in toys and childcare products intended to be placed in the mouth by children under three years of age[2]. Since then and to date, the Commission has renewed this ban on a regular basis (every three months or six months).

The Economic and Social Committee delivered its opinion on the Commission's proposal on 15 February 2000[3].

At its sitting of 6 July 2000, the European Parliament adopted at first reading a legislative resolution[4], together with 12 amendments, on the Commission's proposal.

On 25 May, the Council considered the matter but was unable to reach agreement on a common position. The Council adopted a common position[5], pursuant to Article 251(2), on 4 April 2005, after reaching a political agreement at its meeting of 24 September 2004.

Taking account of the European Parliament's amendments at first reading and the common position of the Council, the Commission published a communication for the information of Parliament on its position, pursuant to the second subparagraph of Article 251(2)[6].

2.   Assessment of the Council's common position

The common position of the Council makes significant changes to the Commission's proposal and to Parliament's first reading. In principle, the six phthalates referred to in Annex I to the proposal for a directive are no longer treated as substances in the same category and as posing the same danger to children's health.

On the basis of the scientific reports and opinions of the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE), the Council strengthens the proposal of the Commission and of the European Parliament by imposing a total ban on the use and placing on the market of three phthalates, DEHP, DBP and BBP, in all toys and childcare articles in concentrations higher than 0.1% by mass of the plasticised material, substances which are classified on the basis of risk assessment as carcinogenic, mutagenic and reprotoxic (category 2). Phthalates are used, usually in large quantities, to increase the pliability of toys or childcare articles made from plasticised material and, therefore, the limit of 0.1% is an endeavour to protect health even against the possibility of adventitious contamination.

As regards the other three phthalates, DINP, DIDP and DNOP, because of the divergent opinions as to the danger they pose, the Council restricted the ban on their use and placing on the market as substances or as constituents of preparations, at concentrations of greater than 0.1% by mass of the plasticised material in toys and childcare articles intended for children under three years of age and which can be placed in the mouth by them. Consequently, the ban does not apply to the substances DINP, DIDP and DNOP which are contained in toys and childcare articles intended for children over the age of three years. It should also be noted that DINPis used in toys in quantities of 35%-45%.

Furthermore, the Council's common position removes all the provisions of the proposal for a directive referring to labelling and information for the consumer, parent and individuals who come into contact with children in relation to toys and childcare articles (see amendment to Directive 88/378/EEC on toys and the provisions of Annex I concerning childcare articles). Even if labelling is not so important for the first category of the most dangerous phthalates identified, it does not mean that the same applies to labelling for the other three phthalates, DINP, DIDP and DNOP, risk assessment for which has not been concluded, although there are indications of harmful effects. Children under the age of three are likely to put toys and childcare products in their mouths which are not intended for that purpose, without parents or others being able to intervene, because they do not have the relevant information. This constitutes a potential threat to those children's health.

As regards the success of Parliament's amendments at first reading, it should be noted that of a total of 12 amendments, the Council did not incorporate any amendment in full or in part in the common position, while only five were accepted in principle (1, 3, 4, 6 and 8). Parliament's amendments which were not accepted in the common position of the Council were: amendment 18 concerning the use of citrates and adipates as substitutes, amendments 2 and 9 concerning the addition of fragrances in toys and childcare articles, amendment 5 concerning the extension of application to other products, amendments 11 and 24 concerning the methods of measuring the migration of phthalates, amendment 7 concerning extending the ban to all phthalates, amendments 16 and 17 rev. concerning 0.05% as the ceiling for concentration of phthalates in the plasticised material.

Although it constitutes a step in the right direction towards a general ban on certain phthalates above a particular concentration limit and, therefore, towards protecting children's health, the Council's common position does not incorporate many of Parliament's amendments, leaving some issues open.

3.   Rapporteur's comments and proposals

Obviously, the protection of children's health and the building of consumer confidence call for a stringent regulatory framework to govern the manufacture and marketing of toys and childcare articles containing certain phthalates in order to reduce, as far as possible, children's exposure to substances which demonstrably give rise to or could potentially cause a health risk.

Consequently, the regulatory framework must be simple and exhaustive so that its implementation can be monitored transparently and fraud and distortion of competition can be avoided, particularly between domestic and imported products; it should also provide for the following: (a) a ban on the use of dangerous phthalates, determined on the basis of a risk assessment, (b) the adoption of rules on labelling on the basis of the precautionary principle, the main aim being to increase the awareness of and information to the parents and, in general, individuals who come into contact with children in the case of phthalates where there are indications that the substances are dangerous but they have not been banned.

Given that children may mouth toys and childcare articles containing DINP, DIDP and DNOP, it is considered that there is a need to ban the use of these substances in toys and childcare articles which can be put in the mouth. For other toys and childcare articles, it is considered that it would be useful to adopt rules on labelling, the main aim being to provide people who come into contact with children with information.

There are proposals request for the development of a method to measure the migration of phthalates, and a review of the directive on the basis of risk assessment and the opinion of the competent scientific authority. Account must also be taken of the exposure of children to risks from sources other than toys and, if appropriate, research must be commissioned to ascertain the values in question. This is also consistent with Parliament’s recent resolution[7] which considers that, without prejudice to existing Community legislation and following the opinion of the Scientific Committee on Health and Environment Risks, urgent consideration is to be given to restricting the marketing and/or the use on the European market of dangerous substances, to which new-born babies, children, pregnant women, elderly persons, workers and other high-risk sections of the population are heavily exposed, as safer alternatives become available, including six products from the phthalate family (DEHP, DINP, DBP, DIDP, DNOP, BBP) in domestic products for indoor use and medical devices, except where such a restriction would have a negative impact on medical treatment.

My proposals as rapporteur are based on the above considerations, which, it should be noted provide the consumer with reliable information without subjecting the market to excessive measures and prohibitions. Furthermore, they enable consumers to be certain in their choices and provide industry with a stable legal framework within which to operate.

It is therefore proposed to reinstate the title of the original proposal submitted by the Commission together with some of Parliament’s amendments in order to incorporate the provisions deleted by the Council, which relate to labelling, safety and risk assessment of phthalates in toys and childcare products (amendments 1, 2, 4, 8, 11 and 24, 6 and 9 from Parliament's first reading).

• [1]  OJ C 304 E, 26.4.2000, p. 14.
• [2]  OJ L 315, 9.12.1999, p. 46.
• [3]  OJ C 117, 26.4.2000, p. 59.
• [4]  OJ C 121, 24.4.2001, p. 410.
• [5]  Council document 5467/05 REV 1.
• [6]  COM(2005) 143 final, 12.4.2005.
• [7]  P6_TA-PROV(2005)0045 on the European Environment and Health Action Plan 2004-2010 (2004/2132(INI)), report by F. Ries A6-0008/2005.

ANNEX

OPINIONS OF

A) SCIENTIFIC COMMITTEE ON HEALTH AND ENVIRONMENTAL RISKS[1]:

· Risk Assessment Report on Benzyl Butyl Phthalate (BBP) Human Health Part” CAS No.: 85-68-7 EINECS No.: 201-622-7. Adopted by the SCHER during the 3rd plenary meeting of 28 January 2005.

B) SCIENTIFIC COMMITTEE FOR TOXICITY, ECOTOXICITY AND THE ENVIRONMENT[2]:

1.  Opinion on "Assessment of the bioavailability of certain elements in toys". Adopted by the CSTEE by written procedure on 22nd June 2004.

2.  Opinion on the risk assessment for acetyl tributyl citrate (ATBC) plasticizer used in children’s toys. Adopted by the CSTEE during the 41th plenary meeting of 8 January 2004.

3.  Opinion on the results of the Risk Assessment of:Bis(2-ethylhexyl) phthalate dehp human health part CAS n°.: 117-81-7 EINECS n°.: 204-211-0 Carried out in the framework of Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances Adopted by the CSTEE during the 41th plenary meeting of 8 January 2004.

4.  Opinion on assessment of the European Committee for Standardisation (CEN) report on the risk assessment of organic chemicals in toys. Report version: final report of the work of CEN/TC 52/WG 9 - January 2003 (Contract BC/CEN/97/29.1.1). Adopted during the 40th plenary meeting on 12 November 2003

5.  Opinion on the results of the Risk Assessment of Bis (2-ethylhexyl) phthalate (DEHP). Report version: Environment , September 2001. Opinion expressed at the 29th CSTEE plenary meeting, Brussels, 09 January 2002

6.  Opinion on the results of the Risk Assessment of: 1,2-Benzenedicarboxylic acid di-C9-11-branched alkyl esters, C10-rich and di-"isodecyl"phthalate - CAS No.: 68515-49-1 and 26761-40-0 - EINECS No.: 271-091-4 and 247-977-1. Report version (Environment): Final report, May 2001 carried out in the framework of Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances. Opinion expressed at the 27th CSTEE plenary meeting, Brussels, 30 October 2001

7.  Opinion on: report on Validation of methodologies for the release of diisononylphthalate (DINP) in saliva simulant from toys (2001 EUR 19826 EN). Opinion expressed at the 25th CSTEE plenary meeting Brussels, 20 July 2001

8.  Opinion on the results of the Risk Assessment of: 1,2-Benzenedicarboxylic acid di-C9-11-branched alkyl esters, C10-rich and di-"isodecyl"phthalate - CAS No.: 68515-49-1 and 26761-40-0 - EINECS No.: 271-091-4 and 247-977-1 - Report version (Human health effects): Final report, May 2001 carried out in the framework of Council Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances. Opinion expressed at the 24th CSTEE plenary meeting, Brussels, 12 June 2001

9.  Opinion on the results of the risk assessment Report of DIBUTYLPHTHALATE CAS N°: 84-74-2 EINECS N°: 201-557-4. Report version carried out in the framework of Council Regulation (EEC) 793/93 on the evaluation and control of the risk of existing substances. Opinion expressed at the 23rd CSTEE plenary meeting, Brussels, 24 April 2001

10.  Opinion on Chapters 6 and 8 (on risk issues) of the RPA ETD/99/502498 Final Report – July 2000 - The Availability of Substitutes for Soft PVC Containing Phthalates in Certain Toys and Childcare Articles. Opinion expressed at the 22nd CSTEE plenary meeting, Brussels, 6/7 March 2001

11.  Opinion on validation of test methods for phthalate migration - Opinion expressed at the 17th CSTEE plenary meeting, Brussels, 5 September 2000

12.  Opinion on the toxicological characteristics and risks of certain citrates and adipates used as a substitute for phthalates as plasticisers in certain soft PVC products. (adopted at the 11th CSTEE plenary meeting on the 28th of September 1999)

13.  Opinion on Phthalate migration from soft PVC toys and child-care articles - Data made available since the 16th of June 1998, opinion expressed at the 6th CSTEE plenary meeting, Brussels, 26/27 November 1998

14.  Opinion on Phthalate migration from soft PVC toys and child-care articles (to answer four new questions put to the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) on the subject), opinion expressed at the 4th CSTEE plenary meeting, Brussels, 16 June 1998

15.  Phthalate migration from soft PVC toys and child-care articles (opinion expressed at the CSTEE third plenary meeting - Brussels, 24 April 1998)

16.  Opinion on Phthalate migration from soft PVC toys and child-care articles (opinion expressed on 9 February 1998).

_____________________________________________

• [1]  . http://europa.eu.int/comm/health/ph_risk/committees/04_scher/scher_opinions_en.htm
• [2]  . http://europa.eu.int/comm/health/ph_risk/committees/sct/sct_en.htm

MENETLUS

Pealkiri	Nõukogu ühine seisukoht eesmärgiga võtta vastu Euroopa Parlamendi ja nõukogu direktiiv, millega muudetakse 22. korda nõukogu direktiivi 76/769/EMÜ liikmesriikide õigus- ja haldusnormide ühtlustamise kohta seoses teatavate ohtlike ainete ja valmististe turustamise ja kasutamise piirangutega (ftalaadid mänguasjades ja lapsehooldusvahendites)
Viited	5467/1/2005 – C6-0092/2005 – 1999/0238(COD)
Õiguslik alus	art 251 lg 2 (EÜ)
Menetlusalus	art 62
EP 1. lugemise kuupäev – P5	6.7.2000		T5-0334/2000
Komisjoni ettepanek	KOM(1999)0577 – C5-0276/1999
Komisjoni muudetud ettepanek
Ühise seisukoha kättesaamisest istungil teada andmise kuupäev	14.4.2005
Vastutav komisjon   istungil teada andmise kuupäev	ENVI 14.4.2005
Raportöör(id)   nimetamise kuupäev	Antonios Trakatellis 20.4.2005
Aseraportöör(id)	Per Arne Arvidsson
Arutamine komisjonis	24.5.2005	14.6.2005
Vastuvõtmise kuupäev	14.6.2005
Lõpphääletuse tulemused	poolt: vastu: erapooletuid:			39 6 4
Lõpphääletuse ajal kohal olnud liikmed	Adamos Adamou, Liam Aylward, Johannes Blokland, John Bowis, Frederika Brepoels, Hiltrud Breyer, Dorette Corbey, Chris Davies, Avril Doyle, Mojca Drčar Murko, Edite Estrela, Karl-Heinz Florenz, Françoise Grossetete, Satu Hassi, Gyula Hegyi, Caroline Jackson, Dan Jorgensen, Eija-Riitta Korhola, Holger Krahmer, Urszula Krupa, Marie-Noëlle Lienemann, Peter Liese, Jules Maaten, Linda McAvan, Roberto Musacchio, Riitta Myller, Péter Olajos, Dimitrios Papadimoulis, Vittorio Prodi, Frédérique Ries, Guido Sacconi, Carl Schlyter, Richard Seeber, Kathy Sinnott, Jonas Sjöstedt, Bogusław Sonik, María Sornosa Martínez, Antonios Trakatellis, Evangelia Tzampazi, Thomas Ulmer, Anja Weisgerber, Asa Westlund, Anders Wijkman
Lõpphääletuse ajal kohal olnud asendusliikmed	Margrete Auken, Milan Gaľa, Vasco Graça Moura, Rebecca Harms, Erna Hennicot-Schoepges, Miroslav Mikolášik
Lõpphääletuse ajal kohal olnud asendusliikmed (kodukorra art 178 lg 2)
Esitamise kuupäev – A6	20.6.2005		A6-0196/2005
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