natgillin/translations-raw huggingface dataset:
Since then and to date, the Commission has renewed this ban on a regular basis (every three months or six months).
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
The Economic and Social Committee delivered its opinion on the Commission's proposal on 15 February 2000
At its sitting of 6 July 2000, the European Parliament adopted at first reading a legislative resolution
At its sitting of 6 July 2000, the European Parliament adopted at first reading a legislative resolution
On 25 May, the Council considered the matter but was unable to reach agreement on a common position.
On 25 May, the Council considered the matter but was unable to reach agreement on a common position.
The Council adopted a common position
The Council adopted a common position
Council document 5467/05 REV 1. , pursuant to Article 251(2), on 4 April 2005, after reaching a political agreement at its meeting of 24 September 2004.
Council document 5467/05 REV 1. , 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)
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)
COM(2005) 143 final, 12.4.2005. .
COM(2005) 143 final, 12.4.2005. .
Assessment of the Council's common position
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.
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.
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).
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.
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 .
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.
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 DINP is used in toys in quantities of 35%-45%.
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).
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.
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.
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.
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).
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.
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.
Rapporteur's comments and proposals
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.
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.
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.
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.
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.
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.
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
This is also consistent with Parliament’s recent resolution
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.
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.
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).
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).
A) VĚDECKÉHO VÝBORU PRO ZDRAVOTNÍ A ENVIRONMENTÁLNÍ RIZIKA
A) SCIENTIFIC COMMITTEE ON HEALTH AND ENVIRONMENTAL RISKS
· Zpráva o posouzení rizika benzyl butyl ftalátu (BBP), část lidské zdraví, CAS číslo 85-68-7 EINECS číslo 201-622-7.
· Risk Assessment Report on Benzyl Butyl Phthalate (BBP) Human Health Part” CAS No.: 85-68-7 EINECS No.: 201-622-7.
Přijata Výborem pro zdravotní a environmentální rizika (SCHER) na 3. plenární schůzi dne 28. ledna 2005.
Adopted by the SCHER during the 3rd plenary meeting of 28 January 2005.
Stanovisko k „Posouzení biodostupnosti některých složek v hračkách“.
Opinion on "Assessment of the bioavailability of certain elements in toys".
Stanovisko k posouzení rizika acetyl tributyl citrátu (ATBC) plastifikátorů používaných v hračkách.
Opinion on the risk assessment for acetyl tributyl citrate (ATBC) plasticizer used in children’s toys.
Přijato CSTEE na 41. plenární schůzi dne 8. ledna 2004.
Adopted by the CSTEE during the 41th plenary meeting of 8 January 2004.
Stanovisko k hodnocení zprávy Evropského výboru pro normalizaci (CEN) o posouzení rizika organických chemických látek v hračkách.
Opinion on assessment of the European Committee for Standardisation (CEN) report on the risk assessment of organic chemicals in toys.
Verze zprávy: závěrečná zpráva práce CEN/TC 52/WG 9. ledna 2003 (Smlouva BC/CEN/97/29.1.1).
Report version: final report of the work of CEN/TC 52/WG 9 - January 2003 (Contract BC/CEN/97/29.1.1).
Přijato na 40. plenární schůzi dne 12. listopadu 2003
Adopted during the 40th plenary meeting on 12 November 2003
Stanovisko k výsledkům posouzení rizika Bis (2-etylhexyl) ftalátu (DEHP ).
Opinion on the results of the Risk Assessment of Bis (2-ethylhexyl) phthalate (DEHP ).
Verze zprávy: Životní prostředí, září 2001.
Report version: Environment , September 2001.
Stanovisko vyjádřené na 29. plenární schůzi CSTEE v Bruselu, 9. ledna 2002
Opinion expressed at the 29th CSTEE plenary meeting, Brussels, 09 January 2002
Stanovisko k výsledkům posouzení rizika rozvětvených alkylesterů 1,2-kyseliny benzenodikarboxylové di-C9-11, C10-mastného di isodecyl ftalátu - CAS č. 68515-49-1 a 26761-40-0 - EINECS č. 271-091-4 a 247-977-1.
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.
Verze zprávy (Životní prostředí): Závěrečná zpráva, květen 2001 provedena v rámci nařízení Rady (EHS) 793/93 o hodnocení a kontrole rizik existujících látek.
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.
Stanovisko vyjádřené na 27. plenární schůzi CSTEE v Bruselu dne 30. října 2001
Opinion expressed at the 27th CSTEE plenary meeting, Brussels, 30 October 2001
Stanovisko ke zprávě o validaci metodologií pro uvolňování diizononylftalátu ( DINP ) v simulovaných slinách z hraček (2001 EUR 19826 EN).
Opinion on: report on Validation of methodologies for the release of diisononylphthalate ( DINP ) in saliva simulant from toys (2001 EUR 19826 EN).
Stanovisko vyjádřené na 25. plenární schůzi CSTEE v Bruselu dne 20. července 2001
Opinion expressed at the 25th CSTEE plenary meeting Brussels, 20 July 2001
Stanovisko k výsledkům posouzení rizika rozvětvených alkylelesterů 1,2-kyseliny benzenodikarboxylové di-C9-11, C10-mastného diisodecyl ftalátu - CAS č. 68515-49-1 a 26761-40-0 - EINECS č. 271-091-4 a 247-977-1 – Verze zprávy (Účinky na lidské zdraví): Závěrečná zpráva, květen 2001 provedeno v rámci nařízení Rady (EHS) 793/93 o hodnocení a kontrole rizik existujících látek.
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.
Stanovisko vyjádřené na 24. plenární schůzi v Bruselu, 12. června 2001
Opinion expressed at the 24th CSTEE plenary meeting, Brussels, 12 June 2001
Stanovisko k výsledkům posouzení rizika Zpráva o DIBUTYLFTALÁTU CAS č. 84-74-2 EINECS č. 201-557-4.
Opinion on the results of the risk assessment Report of DIBUTYLPHTHALATE CAS N°: 84-74-2 EINECS N°: 201-557-4.
Verze zprávy provedená v rámci nařízení Rady (EHS) 793/93 o hodnocení a kontrole rizik existujících látek.
Report version carried out in the framework of Council Regulation (EEC) 793/93 on the evaluation and control of the risk of existing substances.
Stanovisko vyjádřené na 23. plenární schůzi CSTEE v Bruselu, 24. dubna 2001
Opinion expressed at the 23rd CSTEE plenary meeting, Brussels, 24 April 2001
Stanovisko ke kapitolám 6 a 8 (o otázkách rizika) RPA ETD/99/502498 Závěrečná zpráva – červenec 2000 – Dostupnost náhradních látek za měkké PVC obsahující ftaláty v některých hračkách a předmětech pro péči o děti.
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.
Stanovisko vyjádřené na 22. plenární schůzi CSTEE v Bruselu, 6. – 7. března 2001
Opinion expressed at the 22nd CSTEE plenary meeting, Brussels, 6/7 March 2001
Stanovisko k validaci testovacích metod pro uvolňování ftalátů – Stanovisko vyjádřené na 17. plenární schůzi CSTEE v Bruselu, 5. září 2000
Opinion on validation of test methods for phthalate migration - Opinion expressed at the 17th CSTEE plenary meeting, Brussels, 5 September 2000
Stanovisko k toxikologickým vlastnostem a rizikům některých citrátů a adipatů používaných jako náhražka za ftaláty jako plastifikátory v některých výrobcích z měkkého PVC. (přijato na 11. plenární schůzi CSTEE dne 28. září 1999)
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)
Stanovisko k uvolňování ftalátů z hraček a předmětů pro péči o děti vyrobených z měkkého PVC – Údaje jsou dostupné od 16. června 1998, stanovisko vyjádřené na 6. plenární schůzi CSTEE v Bruselu ve dnech 26. – 27. listopadu 1998
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
Stanovisko k uvolňování ftalátů z hraček a předmětů pro péči o děti vyrobených z měkkého PVC (jako odpověď na čtyři nové otázky položené Vědeckému výboru pro toxicitu, ekotoxicitu a životní prostředí (CSTEE) v této věci), stanovisko vyjádřené na 4. plenární schůzi CSTEE v Bruselu, 16. června 1998
Opinion on Phthalate migration f rom 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
Uvolňování ftalátů z hraček a předmětů pro péči o děti vyrobených z měkkého PVC (stanovisko vyjádřené na třetí plenární schůzi CSTEE - Brusel, 24. dubna 1998)
Phthalate migration f rom soft PVC toys and child-care articles (opinion expressed at the CSTEE third plenary meeting - Brussels, 24 April 1998)
Společné stanovisko Rady pro přijetí směrnice Evropského parlamentu a Rady, kterou se po dvacáté druhé mění směrnice Rady 76/769/EHS o sbližování právních a správních předpisů členských států týkajících se omezení uvádění na trh a používání některých nebezpečných látek a přípravků (ftalátů obsažených v hračkách a v předmětech pro péči o děti)
Council common position for adopting a directive of the European Parliament and of the Council amending for the twenty-second time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provision of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles)
Per Arne Arvidsson
Per Arne Arvidsson