Tag Archives: Registration

A new boost to trade in goods

Outline of the Community (European Union) legislation about A new boost to trade in goods

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Free movement of goods: general framework

A new boost to trade in goods

Document or Iniciative

Communication from the Commission of 14 February 2007, “The Internal Market for Goods: a cornerstone of Europe’s competitiveness” [COM(2007) 35 final – not published in the Official Journal].

Summary

Improving the internal market is an ongoing process that requires continuous updating, taking account of recent technological progress, the constantly changing global situation and the needs of consumers.

Following a recent consultation process, the Commission has noted satisfaction at the considerable progress that has been achieved, although there are two major problems:

some national technical rules still constitute important barriers to free trade within the EU, particularly in sectors that have not been harmonised;
several EU rules are inconsistent and a burden to trade.

Small and medium-sized enterprises are the most seriously affected by this problem and the additional tests and red tape it entails.

The Commission proposes four initiatives:

mutual recognition

A proposal for a regulation laying down procedures that the national authorities must follow in applying national technical rules to products lawfully marketed in another Member State. This proposal also envisages the establishment of national “product contact points” to provide information on the applicable technical rules.
This proposal for a regulation will place the emphasis on transparency and efficiency: transparency in the exchange of information between businesses and the national authorities and efficiency by abolishing controls and tests involving duplication of work;
accreditation and surveillance

A proposal for a regulation setting out the requirements for accreditation and market surveillance relating to the marketing of products. This measure will step up market surveillance activities – to ensure that non-compliant products are quickly withdrawn from the market – and make it easier to assess the conformity of goods. In order to do this, the certifications issued by accredited laboratories and testing facilities will have to be accepted throughout the EU;
conformity

A proposal for a decision on a common framework for the marketing of products, aimed at streamlining the various product conformity assessment procedures;
registration of motor vehicles

An interpretative communication on procedures for the registration of motor vehicles originating in another Member State. This will serve as the basis for a citizen’s guide on the transfer of vehicles within the EU, an issue that currently creates numerous practical difficulties as a result of bureaucratic registration formalities.

Background

This Communication is part of the Commission’s review of the Single Market in the 21st Century, which is based on a public consultation procedure launched in April 2006. As part of this review, a comprehensive analysis will be carried out on the four freedoms making up the Single Market, with a final report setting out the initiatives that will supplement the measures described in this Communication.

Transparency register

Outline of the Community (European Union) legislation about Transparency register

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Institutional affairs > The decision-making process and the work of the institutions

Transparency register

Document or Iniciative

Agreement between the European Parliament and the European Commission on the establishment of a transparency register for organisations and self-employed individuals engaged in EU policy-making and policy implementation.

Summary

With this Agreement, the European Parliament and the European Commission have established a common transparency register. This register contains information on organisations and individuals engaged in European policy-making and policy implementation. The information concerns, in particular, their type of activity, the interests they pursue and the resources they devote to their activities.

The register also includes a code of conduct and a complaint mechanism in the event of suspected non-compliance with the code.

The Agreement defines the structure of the transparency register, its scope and the obligations associated with registration.

Representation of interests

In accordance with Article 11 of the Treaty on European Union (EU), the European institutions shall maintain an open, transparent and regular dialogue with representative associations and civil society. The objective is to optimise the formulation and implementation of European policies by maintaining regular and legitimate relations with the principal stakeholders.

Many organisations have opened a ‘European office’ in Brussels for the purposes of representation activities. These activities include asserting their interests and influencing the EU’s decision-making process.

The transparency register therefore aims to register organisations and individuals engaged in these activities and to bring them together around a common code of conduct. It contributes to transparency and to compliance with laws and ethics in order, for example, to avoid excessive pressure or illegitimate access to information and policy-makers.

It is part of the EU’s transparency policy. Registration remains optional and does not constitute a form of EU accreditation of the organisations concerned.

Structure of the register

The register includes:

the scope of the register, eligible activities, sections open to registration (Annex I to the Agreement) and information, including financial information on the registered entities;
a code of conduct (Annex III);
a complaint mechanism and measures to be applied in the event of non-compliance with the code of conduct (Annex IV); these measures include suspension or removal from the register. These measures may lead to the withdrawal of the different types of badges affording access to the European Parliament.

Scope

The scope of the register covers all activities carried out with the objective of directly or indirectly influencing the formulation or implementation of European policies, irrespective of the channel or medium of communication used (media, forums, organising of events, think-tanks, etc.).

All organisations or individuals engaged in this type of activity are therefore expected to register.

However, this Agreement excludes certain activities from the scope of the register:

certain activities concerning the provision of legal and other professional advice to clients in judicial or administrative proceedings;
activities of social partners acting as participants in the social dialogue (trade unions, employers’ associations, etc.);
activities carried out in response to direct and individual requests from EU institutions or Members of the European Parliament.

The register covers all entities engaged in eligible activities (including lobbyists). However, governments of Member States and third countries, international organisations and diplomatic missions are not expected to register. Churches, religious communities and local and regional authorities are not concerned either; however, their offices or the legal entities they set up to represent them are expected to register.

Rules applicable after registration

By registering, the organisations and individuals concerned:

agree that the information which they provide shall be public;
agree to act in compliance with the code of conduct;
guarantee that the information provided is correct;
accept that the complaint mechanism may be implemented.

Implementation of the register

The services of the European Parliament and the European Commission will establish a joint operational structure, to be known as “the joint Transparency Register Secretariat”. This secretariat will be responsible for the ongoing administration of the register and will contribute to the quality of its content.

Context

The new register builds upon and continues the existing registration systems set up by the European Parliament in 1996 and the European Commission in 2008. It is one of the implementing strands of the European Transparency Initiative launched in 2007 by the Commission.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Agreement between the European Parliament and the European Commission	–	–	OJ L 191 of 22.7.2011

Regulatory framework for the management of chemicals , European Chemicals Agency

Outline of the Community (European Union) legislation about Regulatory framework for the management of chemicals , European Chemicals Agency

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Institutional affairs > The institutions bodies and agencies of the union

Regulatory framework for the management of chemicals (REACH), European Chemicals Agency

Document or Iniciative

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [See amending act(s)].

Summary

The European Union (EU) has established REACH, an integrated system for the registration, evaluation, authorisation and restriction of chemicals, together with a European Chemicals Agency. REACH requires firms which manufacture and import chemicals to evaluate the risks resulting from the use of those chemicals and to take the necessary steps to manage any identified risk. Industry has the burden of proving that chemicals produced and placed on the market are safe.

The purpose of the regulation is to ensure a high level of protection of human health and the environment, and to strengthen the competitiveness of the chemicals sector and promote innovation.

Scope

The scope of the Regulation covers all substances *, whether manufactured, imported, placed on the market, or used on their own or in mixtures.

The following are excluded from the scope of the Regulation:

radioactive substances (covered by Directive 96/29/Euratom);
substances under customs supervision which are in temporary storage, in free zones or free warehouses with a view to re-exportation or still in transit;
non-isolated intermediates *;
the transport of dangerous substances; and
waste.

The rules on registration, downstream users, evaluation and authorisation do not apply to substances used in medicinal products for human or veterinary use or in food or feedingstuffs (including additives) provided they fall within the scope of Community legislation on medicinal products or food.

Registration

Registration is the key component of the REACH system. It will be compulsory to register in a central database chemicals which are manufactured or imported in quantities of one tonne or more per annum. The database will be managed by the European Chemicals Agency. If a substance is not registered it cannot be produced or placed on the European market.

Registration will be compulsory from 1 June 2008, but there will be transitional arrangements until 1 June 2018 in some cases for certain substances which must be pre-registered.

Some groups of substances (listed in the Regulation) are, however, exempt from the obligation to register, for instance:

polymers (however monomers which make up polymers must still be registered);
some substances for which the estimated risk is negligible (water, glucose, etc.);
naturally occurring and chemically unaltered substances;
substances used in research and development, under certain conditions.

Registration requires the industry (manufacturers and importers) to provide information on the properties and uses of chemicals and the precautionary measures to be taken when using them (technical dossier). The data required are proportional to the production volume of and the risks presented by the substance concerned (for example, extensive toxicity tests for substances manufactured or imported in quantities of more than 1000 tonnes). An application to register a substance which is imported or manufactured in a quantity of 10 tonnes or more per year must include a detailed description of the risks associated with that substance and the different possible exposure scenarios and risk management measures (chemical safety report).

There are “lighter” requirements for isolated intermediates, provided they are manufactured in strictly controlled conditions and for isolated intermediates which are transported and used under strict control in quantities of less than 1 000 tonnes. In these cases, only the classification, risk management measures and information already available on the properties are required. If more than 1 000 tonnes of the substance are being transported, further information is required.

Likewise, there are special arrangements for the registration of substances present in articles: given the millions of articles that are placed on the market in the EU and the potential risk some of them represent to human health and the environment, certain substances incorporated into articles must be registered. Registration is compulsory when the substance in question is normally released when the article is used and is present in those articles in quantities totalling over one tonne per producer or importer per year. For substances that are not normally released but which are particularly hazardous and are contained in a minimum concentration of 0.1% and placed on the market in quantities of over one tonne per producer or importer per year, simple notification is required, on the basis of which the European Chemicals Agency may request a registration.

The European Chemicals Agency is responsible for managing the database, receiving registration dossiers and developing technical guides aimed at helping manufacturers, importers and the competent authorities in implementing these provisions. During the first eleven years of application of the REACH system, around 30 000 substances already on the market should be registered. It is thought that about 80% of all registered substances will not need any further action.

Data sharing

The Regulation lays down a number of rules on data sharing in order to reduce testing on vertebrate animals and to reduce costs to industry. Provision is made for relevant data to be shared between registrants in exchange for payment.

To the same end, the Regulation requires all registrants of the same substance to submit their applications for registration together except in cases where there are grounds for not doing so, to protect confidential information, in case of disagreement with other registrants, or where joint submission of an application for registration involves disproportionate costs.

Information at the centre of the supply chain

Safety data will be passed throughout the supply chain so that those using chemicals in their production process to manufacture other preparations or articles will be able to do so safely and responsibly, without endangering workers’ or consumers’ health and without putting the environment at risk. This requires information to be passed both up and down the supply chain, and between all actors in that supply chain.

The data transmitted concern, inter alia, identification, composition and properties of the substances, the measures to be taken for use and transport without risk, the measures to be taken in case of fire or accidental release, and toxicological and ecological information. Sensitive information of a commercial nature does not have to be transmitted.

Downstream users

Downstream users must consider the safety of substances, based primarily on information from their suppliers, and to take appropriate risk management measures. These provisions also allow authorities to have an overview of the uses of a substance as it moves through the supply chain and, if necessary, to request further information and take appropriate measures.

Evaluation

Evaluation makes it possible for the Agency to check that industry is fulfilling its obligations and avoiding tests on vertebrate animals when unnecessary. Two types of evaluation are provided for: dossier evaluation and substance evaluation.

Dossier evaluation is to be compulsory for any applications to carry out tests specified in Annexes IX and X to the Regulation (these are the most stringent tests, mostly involving the use of vertebrate animals). The aim is essentially to minimise the need for experiments of this kind. Dossier evaluation may also be carried out in order to check the conformity of a registration. The Agency is expected to carry out a thorough review of at least 5% of the dossiers filed.

Substances suspected of posing a risk to human health or the environment may also be evaluated by the competent authorities in the Member States in order to determine whether further information is required. The evaluation programme is developed by the Agency, in cooperation with the competent authorities.

If a substance is suspected of posing a risk to human health or the environment, the Agency will include this substance in a specific list and a designated Member State will carry out an evaluation in order to determine whether further information is required from the registrant.

Evaluation can lead to the following conclusions:

the substance must be subject to restriction or authorisation procedures;
the classification and labelling of the substance must be harmonised;
information must be supplied to the other authorities so that they can adopt appropriate measures. For example, if, while the substance is being evaluated, information on risk management measures become available and could have an impact on the conditions of use of that substance, the information should be transmitted to the authorities responsible for this legislation.

Authorisation

Substances of extremely high concern may be subject to authorisation by the Commission with regard to particular uses. The objective is to ensure that the risks linked with these substances are validly controlled and that these substances are gradually replaced by other appropriate substances or technologies where this is economically and technically viable.

The Agency publishes and regularly updates a list of substances (‘list of candidate substances’) identified as having characteristics of extremely high concern. These may include the following:

CMRs (carcinogens, mutagens and reproductive toxins);
PBTs (persistent, bioaccumulative and toxic substances);
vPvBs (very persistent and very bioaccumulative substances);
some substances of concern which have irreversible serious effects on humans and the environment, such as endocrine disruptors.

The inclusion of candidate substances on the list involves, under certain conditions, the requirement of information on the presence of this substance in the articles. After inclusion of this substance in Annexe XIV to the Regulation any placing on the market and use of such chemical substances is subject to authorisation. This is granted if the risks arising from the substance in question can be validly controlled. If they cannot and if no alternative exists, the Commission is to assess the level of risk and the socio-economic advantages of using the substance and decide whether to authorise it or not. Some substances, such as PBTs and vPvBs can be authorised only if the socio-economic advantages override the risks and there are no alternatives.

The burden of proof is placed on the applicant. All authorisations must be reviewed after a certain period of time, determined on a case-by-case basis.

Downstream users may use a substance for an authorised use provided they obtain the substance from a company to which an authorisation has been granted and keep within the conditions of that authorisation. However, such downstream users must inform the Agency so that the authorities are fully aware of how certain substances of extremely high concern are being used.

Restriction

The restriction procedure provides a safety net, making it possible to manage the risks which are not adequately covered by other provisions of the REACH system. Proposed restrictions may relate to the conditions of manufacture, use(s) and/or placing on the market of a substance, or the possible prohibition of such activities, if necessary. They are suggested by Member States or by the Agency (at the Commission’s request) in the form of a structured dossier and decided on by the Commission.

European Chemicals Agency

The Regulation establishes a European Chemicals Agency, responsible for managing the technical, scientific and administrative aspects of REACH and ensuring consistency of decision-making at Community level.

The Agency is also to manage the registration process and play a key role in the evaluation process. It receives applications for authorisation and delivers opinions and issues recommendations in relation to the authorisation and restriction procedures.

The Agency’s headquarters are in Helsinki.

Information

Non-confidential information on chemicals is to be available, for example to allow those exposed to chemicals to take decisions as to the acceptability of the associated risks. Some information is accessible free of charge on the Agency’s website, other information on request. However, the Agency may not disclose confidential company data.

Competent authorities

The Regulation requires there to be authorities in each of the Member States with the competence and resources necessary to carry out the tasks assigned to them. These authorities must cooperate with each other and with the Agency in the performance of their duties.

Context

The previous system often proved itself to be incapable of identifying risks posed by many chemicals and was slow to act when risks were identified.

The REACH system is complemented by Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures. This Directive integrates the classification criteria and rules on labelling of the United Nations’ Globally Harmonized System (GHS) with Community legislation and includes the REACH provisions governing the inventory of classifications and labelling.

Key terms used in the act
Substance: a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. Intermediate: a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance. There are: non-isolated intermediates (an intermediate that during synthesis is not intentionally removed from the equipment in which the synthesis takes place), on-site isolated intermediates (an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site) and transported isolated intermediates (an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites).

Key terms used in the act

Substance: a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
Intermediate: a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance. There are: non-isolated intermediates (an intermediate that during synthesis is not intentionally removed from the equipment in which the synthesis takes place), on-site isolated intermediates (an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site) and transported isolated intermediates (an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites).

References

Act	Entry into force – Date of expiry	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 1907/2006	1.6.2007 Application: 1.6.2008 1.8.2008 (Art. 135) 1.6.2009 (Title VIII and Annex XVII)	–	OJ L 136 of 29.5.2007

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 1354/2007	23.11.2007	–	OJ L 304 of 22.11.2007
Regulation (EC) No 1272/2008	20.1.2009	–	OJ L 353 of 31.12.2008

The successive amendments and corrections to Regulation (EEC) No 1907/2006 have been incorporated into the original text.

AMENDMENTS TO THE ANNEXES

Annex II – Requirements concerning the compilation of safety data sheets
Regulation (EU) No 453/2010 [Official Journal L 133 of 31.5.2010].

Annex IV – Exemptions to the registration requirement in compliance with Article 2, paragraph 7, point a)
Regulation (EC) No 987/2008 [Official Journal L 268 of 9.10.2008].

Annex V – Exemptions to the registration requirement in compliance with Article 2, paragraph 7, point b
Regulation (EC) No 987/2008 [Official Journal L 268 of 9.10.2008].

Annex VI – Information requirements
Regulation (EU) No 453/2010 [Official Journal L 133 of 31.5.2010].

Annex XI – General rules on changes to the standard testing system
Regulation (EC) No 134/2009 [Official Journal L 46 of 17.2.2009].

Annex XIV – List of substances subject to authorisation
Regulation (EU) No 143/2011 [Official Journal L 44 of 18.2.2011].

Annex XV – Dossiers
Regulation (EC) No 1272/2008 [Official Journal L 53 of 31.12.2008].

Annex XVII – Restrictions on the manufacture, placing on the market and use of certain dangerous substances and preparations and certain dangerous articles
Regulation (EC) No 1272/2008 [Official Journal L 53 of 31.12.2008];
Regulation (EC) No 552/2009 [Official Journal L 164 of 26.6.2009];
Regulation (EU) No 276/2010 [Official Journal L 86 of 1.4.2010].

Related Acts

Commission Regulation (EC) No 771/2008 of 1 August 2008 laying down the rules of organisation and procedure of the Board of Appeal of the European Chemicals Agency [Official Journal L 206 of 2.8.2008].

Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) [Official Journal L 142 of 31.5.2008].

Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) [Official Journal L 107 of 17.4.2008].

Commission Regulation (EC) No 1238/2007 of 23 October 2007 on laying down rules on the qualifications of the members of the Board of Appeal of the European Chemicals Agency [Official Journal L 280 of 24.10.2007].