natgillin/translations-raw huggingface dataset:
This amendment justifies the further harmonisation of emergency response procedures in the EU.
This amendment justifies the further harmonisation of emergency response procedures in the EU.
This regulation is also intended to guarantee the free movement of chemical substances and mixtures.
This regulation is also intended to guarantee the free movement of chemical substances and mixtures.
Член 46 - параграф 1
Article 46 - paragraph 1
Държавите-членки вземат всички необходими мерки, включително поддържането на система за официален контрол, за да гарантират, че вещества и смеси не се пускат на пазара без да са били класифицирани, етикетирани и опаковани в съответствие с настоящия регламент.
Member States shall take all necessary measures, including maintaining a system of official controls, to ensure that substances and mixtures are not placed on the market, unless they have been classified, labelled and packaged in accordance with this Regulation.
Държавите-членки вземат всички необходими мерки, включително поддържането на система за официален контрол , както и други дейности в зависимост от случая , за да гарантират, че вещества и смеси не се пускат на пазара , без да са били класифицирани, етикетирани и опаковани в съответствие с настоящия регламент.
Member States shall take all necessary measures, including maintaining a system of official controls and other activities, as appropriate to the circumstances , to ensure that substances and mixtures are not placed on the market, unless they have been classified, labelled and packaged in accordance with this Regulation.
From REACH.
From REACH.
Държавите-членки предвиждат разпоредби относно санкциите, налагани при нарушаване разпоредбите на настоящия регламент, и вземат всички необходими мерки за осигуряване на тяхното прилагане.
Member States shall lay down the provisions on penalties applicable to infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented.
Предвидените санкции трябва да бъдат ефективни, пропорционални и възпиращи.
The penalties provided for must be effective, proportionate and dissuasive.
Държавите-членки нотифицират тези мерки пред Комисията не по-късно от осемнадесет месеца след влизането в сила на настоящия регламент и незабавно я нотифицират за всяко последващо изменение, което засяга тези мерки.
Member States shall notify those provisions to the Commission no later than eighteen months after entry into force of this Regulation and shall notify it without delay of any subsequent amendment affecting them.
Държавите-членки уведомяват Комисията относно тези мерки не по-късно от осемнадесет месеца след влизането в сила на настоящия регламент и незабавно я уведомяват за всяко последващо изменение, което засяга тези мерки.
Member States shall notify those provisions to the Commission no later than eighteen months after entry into force of this Regulation and shall notify it without delay of any subsequent amendment affecting them.
Комисията оценява данните относно санкциите и разпространява най-добрите практики по отношение на тяхната ефективност.
The Commission shall assess the data on penalties and disseminate best practice in terms of their effectiveness.
The Commission should analyse the measures that Member States take to ensure a proper implementation of this Regulation.
The Commission should analyse the measures that Member States take to ensure a proper implementation of this Regulation.
Information on the most effective penalties should be disseminated to Member States.
Information on the most effective penalties should be disseminated to Member States.
Член 52 - параграф 1
Article 52 - paragraph 1
Ако държава-членка има основание да счита, че вещество или смес, въпреки че отговаря на изискванията на настоящия регламент, представлява риск за човешкото здраве или за околната среда поради своето класифициране, етикетиране или опаковка, тя може да предприеме съответните временни мерки.
Where a Member State has justifiable grounds for believing that a substance or a mixture, although satisfying the requirements of this Regulation, constitutes a risk to human health or the environment due to reasons of classification, labelling or packaging, it may take appropriate provisional measures.
Държавата-членка незабавно информира Комисията, Агенцията и останалите държави-членки за това, като им предоставя мотивите за своето решение.
The Member State shall immediately inform the Commission, the Agency and the other Member States thereof, giving the reasons for its decision.
Ако , в случай на спор с доставчик, държава-членка има основание да счита, че вещество или смес, независимо дали отговаря на изискванията на настоящия регламент, представлява риск за човешкото здраве или за околната среда поради своето класифициране, етикетиране или опаковка, тя може да предприеме съответните временни мерки.
Where , in the event of a dispute with a supplier, a Member State has justifiable grounds for believing that a substance or a mixture, whether or not it satisfies the requirements of this Regulation, constitutes a risk to human health or the environment due to reasons of classification, labelling or packaging, it may take appropriate provisional measures.
It would be desirable to allow both for the possibility that disputes might arise between suppliers and Member States over the interpretation of requirements under the regulation and for the need to have a procedure for achieving a harmonised classification in the event of such a dispute.
It would be desirable to allow both for the possibility that disputes might arise between suppliers and Member States over the interpretation of requirements under the regulation and for the need to have a procedure for achieving a harmonised classification in the event of such a dispute.
Член 53
Article 53
Комисията може да коригира и адаптира членове 12, 14, 23, 27 до 32 и 37, параграф 2, втора и трета алинея, и приложения I до VII към техническия прогрес.
The Commission may adjust and adapt Articles 12, 14, 23, 27 to 32 and 37 (2) second and third subparagraph and Annexes I to VII to technical progress.
При належаща нужда от спешни действия Комисията може да използва извънредната процедура, посочена в член 54, параграф 4.
On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 54 (4).
Комисията приема приложение VIIa и може да коригира и адаптира приложения I до VIIа към техническия и научен прогрес в съответствие с правилата, определени в настоящия регламент .
The Commission shall adopt Annex VIIa and may adjust and adapt Annexes I to VIIa to technical and scientific progress in accordance with the rules laid down in this Regulation .
Комисията надлежно взема предвид последващото развитие на GHS в рамките на Организацията на обединените нации, постиженията на международните програми и конвенции за химически вещества, данните от бази данни относно злополуки, като например информационни източници относно отравяния и Европейската система за надзор на битовите злополуки и на злополуките през свободното време (EHLASS), както и утвърждаването на алтернативни изпитвания от Европейския център за утвърждаване на алтернативни методи (ECVAM).
The Commission shall take due account of the further development of the GHS within the United Nations, developments in international chemical programmes and conventions, data from accident databases, such as poison information units and the European Home and Leisure Accident Surveillance System (EHLASS), and the validation of alternative tests by ECVAM.
Комисията насърчава хармонизирането на етикетирането на веществата, които са устойчиви, биоакумулативни и токсични (РВТ), и веществата, които са много устойчиви и силно биоакумулативни (vPvB), на ниво ООН, като, по целесъобразност, впоследствие коригира и адаптира раздели 1.1 и 1.2 на приложение II и част 2 на приложение III, както е посочено в член 27, параграф 1, и/или част 2 на приложение II и част 3 на приложение III, в съответствие с разпоредбите на член 24.
The Commission shall promote the harmonisation of the labelling of PBT and vPvB at the level of the United Nations and shall, as appropriate, subsequently adjust and adapt sections 1.1 and 1.2 of Annex II and part 2 of Annex III referred to in Article 27(1) and/or part 2 of Annex II and part 3 of Annex III referred to in Article 24.
The adaptation of the regulation to technical and scientific progress is necessary, but it can only take place within the legal framework adopted in co-decision.
The adaptation of the regulation to technical and scientific progress is necessary, but it can only take place within the legal framework adopted in co-decision.
Articles of this Regulation should only be amended in co-decision.
Articles of this Regulation should only be amended in co-decision.
In the further adaptations, developments in GHS and other international chemical programmes and conventions must be taken into account.
In the further adaptations, developments in GHS and other international chemical programmes and conventions must be taken into account.
Accident databases provide information on practical impacts of this legislation, which should also be considered.
Accident databases provide information on practical impacts of this legislation, which should also be considered.
In 1980 the debate on chemicals and the part they play in our lives opened at international level, first within the International Labour Organisation and then within the United Nations which, following various interim stages (Rio in 1992, Johannesburg in 2002), adopted the GHS in December 2002 (with a revision in 2005).
In 1980 the debate on chemicals and the part they play in our lives opened at international level, first within the International Labour Organisation and then within the United Nations which, following various interim stages (Rio in 1992, Johannesburg in 2002), adopted the GHS in December 2002 (with a revision in 2005).
At European level:
At European level:
§ In 2001, the Commission published a White Paper entitled 'Strategy for a future Chemicals Policy', in which it stated that it intended to propose that the GHS be incorporated into Community legislation.
§ In 2001, the Commission published a White Paper entitled 'Strategy for a future Chemicals Policy', in which it stated that it intended to propose that the GHS be incorporated into Community legislation.
§ 29 October 2003: in the Explanatory Memorandum to the amendment to Directive 67/548/EC adopted together with REACH, the Commission stated its intention to draft a proposal on the GHS.
§ 29 October 2003: in the Explanatory Memorandum to the amendment to Directive 67/548/EC adopted together with REACH, the Commission stated its intention to draft a proposal on the GHS.
§ Stakeholder consultations were held between 21 August 2006 and 21 October 2006.
§ Stakeholder consultations were held between 21 August 2006 and 21 October 2006.
370 contributions were received.
370 contributions were received.
§ 27 June 2007: the Commission adopted the proposal.
§ 27 June 2007: the Commission adopted the proposal.
· In June 2007, REACH, one of the main strands of the chemicals policy, entered into force.
· In June 2007, REACH, one of the main strands of the chemicals policy, entered into force.
The GHS is an voluntary international harmonisation programme which the EU decided to join in order to establish a common, consistent basis for dealing with chemical hazards which set out fundamental rules to ensure:
The GHS is an voluntary international harmonisation programme which the EU decided to join in order to establish a common, consistent basis for dealing with chemical hazards which set out fundamental rules to ensure:
- safety in the transport of hazardous goods;
- safety in the transport of hazardous goods;
- protection of consumer and worker health and safety and of the environment.
- protection of consumer and worker health and safety and of the environment.
Specifically, the proposal for a regulation:
Specifically, the proposal for a regulation:
· harmonises the classification of substances and mixtures and the rules on the labelling and packaging of hazardous substances and mixtures;
· harmonises the classification of substances and mixtures and the rules on the labelling and packaging of hazardous substances and mixtures;
· introduces an obligation for suppliers to classify substances and mixtures;
· introduces an obligation for suppliers to classify substances and mixtures;
· establishes a list of substances with their harmonised classifications and labelling at Community level (in part 3 of Annex VI);
· establishes a list of substances with their harmonised classifications and labelling at Community level (in part 3 of Annex VI);
· establishes a classification and labelling inventory which is made up of all notifications, submissions and harmonised classifications.
· establishes a classification and labelling inventory which is made up of all notifications, submissions and harmonised classifications.
Given the scale of international trade in chemicals, it was felt that an international harmonised classification and labelling system was the best means of ensuring – in addition to safety – the quality and consistency of information on products manufactured locally or imported and of monitoring exposure to substances and, thereby, health and environmental protection standards worldwide.
Given the scale of international trade in chemicals, it was felt that an international harmonised classification and labelling system was the best means of ensuring – in addition to safety – the quality and consistency of information on products manufactured locally or imported and of monitoring exposure to substances and, thereby, health and environmental protection standards worldwide.
Clearer, understandable and relevant information provision to consumers will ensure that this legislation produces optimum results.
Clearer, understandable and relevant information provision to consumers will ensure that this legislation produces optimum results.
As things currently stand, the same substance or percentage concentration of a substance may be classified in a very different way from one country to another owing to the use of different classification systems.
As things currently stand, the same substance or percentage concentration of a substance may be classified in a very different way from one country to another owing to the use of different classification systems.
Substances which in Europe are classified as hazardous may – for example in countries such as China – not carry any warnings on their labels.
Substances which in Europe are classified as hazardous may – for example in countries such as China – not carry any warnings on their labels.
In addition to giving rise to unfair competitive advantages, this situation is a serious threat to consumers everywhere, particularly in a global market.
In addition to giving rise to unfair competitive advantages, this situation is a serious threat to consumers everywhere, particularly in a global market.
This is one of the main reasons why the Commission and the Member States took part in the work carried out by the United Nations and decided to incorporate the system into European legislation.
This is one of the main reasons why the Commission and the Member States took part in the work carried out by the United Nations and decided to incorporate the system into European legislation.
Chemicals are produced and traded throughout the world, and the risks are the same irrespective of location.
Chemicals are produced and traded throughout the world, and the risks are the same irrespective of location.
The risk classification system must therefore not differ from country to country.
The risk classification system must therefore not differ from country to country.
The risk or lack of risk is the same for consumers everywhere.
The risk or lack of risk is the same for consumers everywhere.
GHS time limits
GHS time limits
The reclassification and labelling of substances must be completed by:
The reclassification and labelling of substances must be completed by:
· 1 December 2010 for substances (3.5 years after the entry into force of REACH);
· 1 December 2010 for substances (3.5 years after the entry into force of REACH);
· 1 June 2015 for mixtures (4.5 years after the entry into force of REACH).
· 1 June 2015 for mixtures (4.5 years after the entry into force of REACH).
The time limits run from the entry into force of REACH, and any further delay in the adoption of this regulation could place a heavy burden on companies and their staff.
The time limits run from the entry into force of REACH, and any further delay in the adoption of this regulation could place a heavy burden on companies and their staff.
Therefore, given that the text comes from the United Nations and is the product of international negotiations in which the Commission and all the Member States took part, it has been decided to table only as many amendments as are necessary to bring the proposal into line with existing provisions in the sector and make it more consistent with REACH.
Therefore, given that the text comes from the United Nations and is the product of international negotiations in which the Commission and all the Member States took part, it has been decided to table only as many amendments as are necessary to bring the proposal into line with existing provisions in the sector and make it more consistent with REACH.
СТАНОВИЩЕ на комисията по вътрешния пазар и защита на потребителите
OPINION of the Committee on the Internal Market and Consumer Protection (*)
относно предложението за регламент на Европейския парламент и на Съвета относно класифицирането, етикетирането и опаковането на вещества и смеси и за изменение на Директива 67/548/ЕИО и Регламент (ЕО) № 1907/2006
on the proposal for a regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006
(*) Процедура с асоциирани комисии – член 47 от Правилника
(*) Procedure with associated committees - Rule 47 of the Rules of Procedure
Background on the proposal
Background on the proposal
The proposal for a regulation on classification, labelling and packaging of substances and mixtures
The proposal for a regulation on classification, labelling and packaging of substances and mixtures
COM(2007)355 of 27.6.2007 is implementing in the EU the international criteria agreed by the United Nations Economic and Social Council for the classification and labelling of hazardous substances and mixtures.
COM(2007)355 of 27.6.2007 is implementing in the EU the international criteria agreed by the United Nations Economic and Social Council for the classification and labelling of hazardous substances and mixtures.
This is also known as the Globally Harmonised System (GHS).
This is also known as the Globally Harmonised System (GHS).
The objective is to ensure a high level of protection of human health and the environment, while guaranteeing the free movement of substances and mixtures within the internal market.
The objective is to ensure a high level of protection of human health and the environment, while guaranteeing the free movement of substances and mixtures within the internal market.
GHS establishes harmonized criteria for classifying substances and mixtures according to the health, environmental and physical hazards, as well harmonized hazard communication elements, including requirements for labelling and safety data sheets.
GHS establishes harmonized criteria for classifying substances and mixtures according to the health, environmental and physical hazards, as well harmonized hazard communication elements, including requirements for labelling and safety data sheets.
This applies to transport of chemicals, the use in the workplace of chemicals as well as labelling in the consumer sector.
This applies to transport of chemicals, the use in the workplace of chemicals as well as labelling in the consumer sector.
The new legislation will replace the currently existing provisions on classification and labelling of chemicals.
The new legislation will replace the currently existing provisions on classification and labelling of chemicals.
The current EU system and the GHS system are conceptually similar and cover the same structural elements: classification, packaging and hazard communication including labelling and safety data sheets.
The current EU system and the GHS system are conceptually similar and cover the same structural elements: classification, packaging and hazard communication including labelling and safety data sheets.
Some of the criteria for classification will however change with the new system.
Some of the criteria for classification will however change with the new system.
The purpose of the regulation is to facilitate trade and hence to ensure a well-functioning internal market and it will benefit producers, professional users and consumers.
The purpose of the regulation is to facilitate trade and hence to ensure a well-functioning internal market and it will benefit producers, professional users and consumers.
Relation to REACH
Relation to REACH
The recent adopted Regulation on Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH)
The recent adopted Regulation on Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH)
Regulation (EC) No 1907/2006 on the European Parliament and of the Council. includes references to substance and preparation classification as well to Safety Data Sheet but does not include the criteria for such classification.
Regulation (EC) No 1907/2006 on the European Parliament and of the Council. includes references to substance and preparation classification as well to Safety Data Sheet but does not include the criteria for such classification.
The identification of these criteria is the core of the GHS proposal.
The identification of these criteria is the core of the GHS proposal.
In particular, potential registrants are required to submit information on substance classification at the registration stage.
In particular, potential registrants are required to submit information on substance classification at the registration stage.
This information, as well as any other provisions based on classification criteria, will therefore relies on the criteria set up in the GHS proposal.
This information, as well as any other provisions based on classification criteria, will therefore relies on the criteria set up in the GHS proposal.
Finally, the provisions on the mandatory notification to the classification and labelling inventory currently included in REACH will be moved in to the GHS Regulation.
Finally, the provisions on the mandatory notification to the classification and labelling inventory currently included in REACH will be moved in to the GHS Regulation.
Essentially, the new regulation will establish the provisions for suppliers of substances and mixtures to obtain available information for evaluating the intrinsic hazards of these substances and mixtures with the aim of labelling them with this information on the hazards and appropriate precautionary measures to be taken before being placed on the market.
Essentially, the new regulation will establish the provisions for suppliers of substances and mixtures to obtain available information for evaluating the intrinsic hazards of these substances and mixtures with the aim of labelling them with this information on the hazards and appropriate precautionary measures to be taken before being placed on the market.
REACH, on the other hand, requires that manufacturers and importers of substances assess the risks in relation to identified uses with the aim of providing concrete instructions to downstream users on control of such risks during use, and that this is documented in a registration to the European Chemicals Agency.
REACH, on the other hand, requires that manufacturers and importers of substances assess the risks in relation to identified uses with the aim of providing concrete instructions to downstream users on control of such risks during use, and that this is documented in a registration to the European Chemicals Agency.