Regulation (EC) No. 1907/2006 (REACH)

from Wikipedia, the free encyclopedia
European Union flag

Regulation (EC) No. 1907/2006

Title: Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of December 18, 2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), on the creation of a European Chemicals Agency, on the amendment of Directive 1999/45 / EC and repealing Council Regulation (EEC) No. 793/93, Commission Regulation (EC) No. 1488/94, Council Directive 76/769 / EEC and Directives 91/155 / EEC, 93/67 / EEC, 93/105 / EC and 2000/21 / EC of the Commission
Designation:
(not official) 		REACH regulation
Scope: EEA
Legal matter: Chemical law , administrative law , environmental law
Basis: EGV , especially Art. 95
Procedure overview: European Commission
European Parliament
IPEX Wiki
Date of issue: December 18, 2006
Release date: December 30, 2006
Come into effect: June 1, 2007
To be used from: June 1, 2008
Regulations regarding the registration of substances, sharing of data and avoidance of unnecessary tests, downstream users, assessment, authorization, classification and labeling area as well as information
August 1, 2008
Transitional measures regarding notified substances
June 1, 2009
Regulations regarding restrictions for the Manufacture, placing on the market and use of certain dangerous substances and preparations as well as restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles
Replaces: Directive 76/769 / EEC
Directive 91/155
/ EEC
Directive
93/67 / EEC Directive 93/105 / EC Regulation (EEC) No. 793/93
Regulation (EC) No. 1488/94 Directive 2000/21
/ EC
Last change by: Regulation (EU) 2020/1149
Effective date of the
last change: 		February 27, 2020
Reference: OJ L 396 of 30.12.2006, pp. 1–851
Full text Consolidated version (not official)
basic version
Regulation has entered into force and is applicable.
Please note the information on the current version of legal acts of the European Union !

The Regulation (EC) no. 1907/2006 (REACH) is an EU chemicals regulation, which entered into force on 1 June 2007. REACH stands for R egistration, E valuation, A uthorisation and Restriction of Ch emicals , registration, evaluation, authorization and restriction of chemicals' . As an EU regulation , REACH is equally and directly valid in all member states. REACH has fundamentally harmonized and simplified the previous chemicals law . In addition, various decrees such as the EU Nickel Directive have been replaced by REACH. The ordinance has been continuously updated and adapted since it came into force.

Basics

The REACH system is based on the principle of personal responsibility for industry. According to the principle of no data, no market , only chemical substances that have been previously registered may be placed on the market within the scope of application. Every manufacturer or importer who wants to market his substances that fall within the scope of REACH must have their own registration number for these substances.

One year after REACH came into force, the previous legislation continued to apply until the newly established European Chemicals Agency (ECHA) in Helsinki was fully operational . ECHA is primarily responsible for organizing and controlling the REACH process.

On June 1, 2008, the semi-annual pre-registration period for certain substances began. The pre-registration precedes the actual registration. It serves to form forums in which manufacturers and importers of substances should exchange ideas. In return, manufacturers / importers receive extended registration deadlines with the free pre-registration, depending on the quantities and properties of the substance.

The data requirements increase with the volume range of the substance to be registered. In addition to a technical dossier, it may be necessary to prepare a chemical safety report . In the case of dangerous and worrying substances (e.g. carcinogenic or persistent substances), exposure scenarios must be determined in the chemical safety report . These are quantitative or qualitative estimates of the dose / concentration of the substance that is or can be exposed to humans and the environment. The entire life cycle of the substance (from manufacture to use to disposal) must be taken into account. Substantial parts of this data are made available to the public via an internet database.

Before new animal experiments are carried out to determine toxicological and ecotoxic data, there is an obligation to inquire within the forum formed after the pre-registration whether the corresponding data is already available. REACH obliges manufacturers / importers to share data here.

After registration, a work plan is drawn up for the assessment of the substances by the Member States. Substances of particular concern and widespread use are prioritized. The assessment can, among other things, result in a restriction or authorization procedure for substances. Individual uses of the substance can be prohibited in the restriction procedure. In the case of substances that are subject to authorization, however, all uses are prohibited unless authorization has been granted for a specific use.

Another special feature of REACH is the expansion of communication in the supply chain. Downstream users (or downstream users ) receive additional tasks and obligations. They must provide their upstream manufacturers or importers of substances subject to registration (see scope) with information on the exact use so that they can consider the use in their information on exposure (in the technical dossier) and, if applicable, in their exposure scenarios and recommend suitable risk reduction measures. The use then becomes an “identified use”. The downstream user has the duty to apply the risk reduction measures.

If the manufacturer / importer does not identify the individual use (because, for example, from his point of view the risk of this use is too great) or if the downstream user does not want to disclose the use in order to protect business secrets, the downstream user may have to prepare his own chemical safety report.

In the case of substances that require authorization, the downstream user can submit his own application for authorization for his use.

The most important tool for communication in the supply chain remains the safety data sheet . In future, the registration number, any information on the restriction of uses, any information on the authorization requirement and the "identified uses" must also be included here.

In Germany, violations of the European REACH regulation are punishable by the national chemical sanctions regulation .

The scope

Manufacturers or importers who manufacture substances with more than one tonne per year in the European Union or import them into the European Union, be it as a substance, as a component of a mixture or as an ingredient of an article to be released, fall within the scope of REACH. However, some substances are wholly or partially excluded (see below). However, the REACH regulation is also aimed at so-called "downstream users" (Art. 1, Paragraph 3); ultimately every person who handles such substances and therefore - often under national law under threat of sanctions - z. B. is subject to restrictions on the manufacture, use or placing on the market of certain dangerous substances, products and mixtures.

Manufacturers / importers are natural or legal persons based in the European Community who manufacture a substance in the European Community or are responsible for importing it (Article 3 REACH Regulation).

Manufacturers in the form of a natural or legal person based outside the Community who import substances, mixtures and / or products into the Community can, by mutual consent, appoint a natural or legal person based in the Community to act as their sole representative (Only Representative) fulfills the obligations for importers. If an only representative is appointed, the manufacturer outside the community informs the members of his supply chain based within the community (Article 8 REACH Regulation).

material

The substance definition is decisive under REACH:

“Substance: chemical element and its compounds in natural form or obtained through a manufacturing process, including the additives necessary to maintain its stability and the impurities caused by the process used, but with the exception of solvents that are produced by the substance without impairing its stability and without Change in its composition can be separated. "

This term definition therefore not only includes a single substance ( mono-constituent substance ), but also substances made up of several chemical compounds with known composition ( multi-constituent substances ) as well as substances with unknown, variable or complex composition or biological material ( UVCB , Unknown or Variable composition, complex reaction products or biological material ).

New and known fabrics

Substances that have been registered in accordance with Directive 67/548 / EEC (Substances Directive ) since 1981 (the so-called new substances on the ELINCS list) are already registered . Substances that are newly manufactured or imported must be registered beforehand (so-called non-phase-in substances). In contrast, there is a transition period for substances that are already known but are not subject to the strict rules of the Substances Directive (see “ Pre-registration ”); These are therefore called phase-in substances (from English to phase in , to be introduced gradually ) and must also comply with the REACH rules by 2018 at the latest.

Phase-in substances are:

  • The so-called “ old substances ” that are listed in the EINECS directory;
  • The substances on the No Longer Polymers List (NLP);
  • Substances that have been manufactured in the EU but were not placed on the market by the manufacturer / importer in the 15 years before REACH came into force, for example in-house substances. (Corresponding evidence of the time of production and that the substances were not passed on to third parties must be available.)
Substances not or only partially affected by REACH

The following do not fall within the scope of REACH:

In general, substances that are already adequately regulated by other legal regulations can be excluded completely (see above) or from parts of the REACH regulation. Substances that are used to manufacture cosmetic products are subject to registration; however, the chemical safety report does not have to take into account the risks to human health resulting from the end use. In the following, further substances are listed that are excluded from registration (but not from the assessment with a possible restriction or authorization procedure):

  • Substances in human or veterinary medicine;
  • Substances in the food and feed sector;
  • Plant protection and biocidal active substances (count as registered substances);
  • Re-imports of already registered substances;
  • Substances for product and process-oriented research and development;
  • Substances that are recovered in the context of recycling (if the original substance is registered);
  • Registered new substances;
  • Substances in Annex IV (e.g. water, sugar, limestone) of the regulation;
  • Substances of Annex V (for example natural substances - if not dangerous) of the regulation.

The pre-registration

Pre-registration was only possible for phase-in substances (see above, scope). It wasn't mandatory. Manufacturers and importers have nevertheless carried out a pre-registration of their phase-in substances, as the principle of “no data, no market” has been in effect since December 1, 2008. Since then, manufacturers / importers are no longer allowed to place their phase-in substances on the market until they have fully registered them and have a registration number.

In addition, manufacturers / importers received two major advantages through pre-registration. On the one hand, depending on the annual volume, they received a transition period (see table) for full registration. On the other hand, participation in a SIEF requires pre-registration.

Transition periods according to Article 23 of the REACH Regulation
Quantity band Implementation deadline
≥ 1000 t / a December 1, 2010
CMR substances ≥ 1 t / a December 1, 2010
Environmentally hazardous substances ≥ 100 t / a December 1, 2010
Notification obligation Art 7 (4) June 1, 2011
≥ 100 t / a 1st June 2013
≥ 1 t / a June 1, 2018

Since October 9, 2008, the ECHA has published a provisional list of the pre-registered substances, deviating from the planning.

The final deadline for “subsequent pre-registration” ended on May 31st. 2017. From June 1, 2018, an inquiry under Article 26 ( Inquiry Dossier , obligation to make inquiries before registration ) must first be submitted to the Agency before a substance can be registered.

SIEF data forum

SIEF stands for Substance Information Exchange Forum . It was the purpose of the pre-registration that the different manufacturers or importers of identical substances could find each other. Data on substances are to be exchanged in the SIEF.

The pre-registration was done electronically to the ECHA ( European Chemicals Agency , European agency for chemical substances based in Helsinki). It was free of charge and without obligation. Pre-registration could take place in two forms. The first possibility was the "single preregistration" via REACH-IT, an ECHA web portal. The second possibility for pre-registration was the XML format as a so-called BULK registration. The IUCLID 5 program, for example, could be used for this. The following data, which should already be available to the manufacturers / importers, had to be given during the pre-registration:

  • Identification of the substance, substance name and for example EINECS and CAS number ;
  • Name and address of the manufacturer / importer and the names of contact persons (optional);
  • The envisaged deadlines for registration, ultimately the tonnage band (information is not binding);
  • Substance names that can be important for structural analogies.

ECHA limited the volume for bulk registration to 10,000 substances at the beginning of October. Companies that wanted to pre-register more extensive substance inventories had to consult with ECHA.

abuse

REACH particularly affects non-EU companies that import into the European economic area. You need a representative in the EU to cover your legal obligations. There are now known cases in which companies based outside the community want to have pre-registrations carried out without a sole representative. It is therefore necessary to check whether the pre-registration has really taken place. To do this, you should find out the address of the company and its UUID (Universally Unique Identifier) ​​on the website or the DUNS number, according to a source from the BDI. If there are any doubts about registration, a (buyer) buyer can also ask the registrant or seller / trader for the registration number issued by ECHA from December 2008.

By mid-September 2008 over 350,000 pre-registrations had been entered in the ECHA database, almost twice as many as originally expected (200,000). Many pre-registrations appear to have been made by consultancies who want to offer their services as the sole agent to manufacturers based outside the community. Some of these consulting firms have even made themselves SIEF moderators.

Even consulting firms based outside the community offer their services to ignorant manufacturers as the sole representative, although according to the REACH regulation only companies based within the community are entitled to (pre) register substances.

On September 21, 2011, the pre-registrations were adjusted. Pre-registrations by companies outside the EU were therefore invalid.

The registration

Article 10 of the REACH regulation describes in general the information that must be submitted for registration purposes. A technical dossier must be submitted using IUCLID 6 for all phase-in substances and non-phase-in substances from 1 t / a . A chemical safety report is also required for substance quantities above 10 t / a. Under certain conditions, a dossier can also be created and submitted online by a co-registrant via the REACH-IT platform.

By the end of May 2018, 13,620 companies had submitted 88,319 registration dossiers for 21,551 substances.

The technical dossier

In addition to the identity of the manufacturer / importer and the identity of the substance, the technical dossier must contain the following information:

  • Classification and labeling of the substance;
  • Information on manufacture and use (s) of the substance;
  • Guidelines on safe use of the substance;
  • Expert review (what information has been reviewed by an expert?);
  • Request for the confidentiality of certain information (according to Art. 119 Paragraph 2; see Internet access to REACH data );
  • Information on exposure (uses, routes of exposure, frequency of exposure);
  • Data set according to Annexes VII (amount of substance ≥ 1 t / a), VIII (amount of substance ≥ 10 t / a), IX (amount of substance ≥ 100 t / a), X (amount of substance ≥ 1000 t / a);
  • Simple / qualified study summary (s).

The required data sets according to Annexes VII to X contain not only the physical and chemical properties but also information on toxicology and ecotoxicity . The corresponding test methods are specified in Regulation (EC) No. 440/2008 .

Before a registrant attempts to meet the information requirements for registration, he must inquire within his SIEF whether a relevant study is available. Vertebrate studies should not be repeated.

New experiments to collect data are to be carried out in accordance with GLP (Good Laboratory Practice). Under certain conditions, which are described in Annex XI, tests can be omitted with justification. For this, appropriate waiving methods ( e.g. data on substances of the same substance group or data from existing tests that were not carried out according to GLP) must provide the required information.

REACH distinguishes between two types of study summaries. The simple study summary for substance quantities ≥ 1 t / a contains the information in the respective Annexes VII to X with descriptions of the aim, method, result and conclusion of a study. With the simple study summary, the relevance of a study can be assessed. From a substance quantity of ≥ 10 t / a, a qualified study summary must also be created. This should enable an independent evaluation of the study.

The chemical safety report

According to Article 10 b) for substance quantities from 10 t / a is a so-called CSR (CSR for English chemical safety report ) is required. Its core is the description of the exposure of a substance and its effect on humans and the environment. The assessments of the exposure and the effect result in a risk that must also be described for hazardous substances.

The chemical safety report requires communication within the supply chain. The know-how about exposure of a substance is mainly derived from its use and naturally lies more with the downstream user. The know-how about the effect of a substance and the risk management measures lies primarily with the manufacturer or importer.

Annex I of the REACH regulation describes the form and content of the chemical safety report. Thus, a CSA is (CSA for English Chemical Safety Assessment ) to carry out the following steps:

  1. Hazard assessment on the health of people with derivation of a DNEL ( English derived no-effect level );
  2. Determination of harmful effects on human health through physico-chemical properties;
  3. Hazard Assessment on the environment deriving PNECs ( English predicted no-effect concentration ) for the compartments of water, soil, air, and for the food chain and the microbiological activity in sewage treatment plants;
  4. Determination of the PBT (persistent, bioaccumulating, toxic) and vPvB (very persistent, very bioaccumulating) properties.
  5. Exposure assessment with development of one or more exposure scenarios or, if necessary, development of relevant use and exposure categories ;
  6. Risk description.

The manufacturer or importer uses steps 1 to 4 to check whether the substance is classified as hazardous according to Regulation (EC) No. 1272/2008 (CLP Regulation) or as PBT or vPvB. In this case, the chemical safety assessment also includes steps 5 and 6, otherwise these are omitted.

An exposure scenario describes all conditions (for example during manufacture, processing, use and disposal) over the entire life of the substance. The exposure scenario also describes measures to control exposure to humans and the environment. These conditions of use and measures to control exposure are risk management measures in the broadest sense.

A use and exposure category is an exposure scenario that covers a wide range of processes and uses.

Internet access to REACH data

A key element of the REACH regulation is that the data transmitted to the European Chemicals Agency (ECHA) in the registration process are available to the public via an internet database. The principle is “no data, no market”. According to Art. 119 Para. 1 REACH Regulation, certain data must be published in any case. For the Art. 119 para. 2 mentioned data, companies can in the registration dossier a request for confidentiality filters ( Confidentiality Claim ). A guide from the agency explains which requirements must be met for this (fee-based) application.

In addition, the agency has requirements of international law (Aarhus Agreement) and its implementation in secondary EU law (Regulation 1367/2006) as well as the transparency requirements of primary law (Art. 15 of the Treaty on the Functioning of the European Union [TFEU]) Note: Within the framework of the Aarhus Agreement and Article 4 of EC Regulation 1367/2006, the agency is obliged to “actively and systematically disseminate information to the public”. The agency - like other EU organs - has the duty to enter the environmental information in its possession into databases and to provide this with search aids and other software to support the public in searching for the desired information (Art. 4 para. 1 Sentence 3 Regulation 1367/2006). According to Art. 15 TFEU, the agency is also obliged to act in compliance with the principle of openness to the greatest possible extent ( as openly as possible ).

On August 14, 2014, the database contained information on 12,636 substances from 48,801 registration dossiers. As of December 7, 2017, the database contained information on 17,010 substances and 64,744 registration dossiers. These include a. Information on chemical and physical properties as well as toxicity for humans and the environment. It also lists the quantities (in tons per year) in which these substances are marketed in the EU according to the information in the registration dossiers. This provides a database that is unique worldwide in this form, with the help of which the problem of “toxic ignorance” (lack of knowledge about the toxic effects of the chemicals used in industry) is gradually reduced. When the last transition period for "existing substances" expires in 2018, the volume of data will once again increase significantly. With the database, the REACH regulation also makes a contribution to the “democratization of risk knowledge”. However, the data are based on input from those responsible for the substance in the chemical industry; the majority of them are uncontrolled and can therefore be found in the database without being corrected. The quality of the data in the ECHA database is therefore criticized - also by the European Commission and the European Chemicals Agency.

The review

After submitting the registration documents, ECHA carries out a completeness check in accordance with Article 20 of the REACH Regulation. It checks whether the fee has been paid and whether all data is available. There is no quality check. So far, the quality only had to be assessed randomly in 5% of the submitted dossiers. By the end of 2023, however, at least 20% of the registration dossiers submitted in quantities of 100 tonnes or more per year must be reviewed; By the end of 2027, this minimum percentage must also be achieved for dossiers submitted in smaller quantity ranges.

ECHA prepared a work plan ( CoRAP ) for the risk assessment of the substances by December 1, 2011 . The substances were prioritized according to a risk-oriented concept. To be taken into account

  • properties of concern such as persistence and bioaccumulation ;
  • exposure and
  • the total amount registered (from the sum of all registrants).

The work plans have been updated annually by ECHA since December 1, 2011. The substances in the work plan are evaluated by the Member States, which then act as competent authorities.

After evaluating the substances, the competent authorities submit their draft decisions. These can include follow-up actions such as:

The procedures for admission and restriction

The following table lists the substances that are subject to special legal regulations in accordance with the REACH approval procedure and restriction procedure:

Admission process Restriction procedure
List of substances of very high concern for authorization
Short description: SVHC list or candidate list
(Candidate List of substances of very high concern for Authorization)

Even the inclusion of a substance in the “List of substances of very high concern for authorization” results in legal obligations for companies that manufacture, import or use the substance as such, in mixtures or in articles .

⇩

List of substances subject to authorization - Annex XIV of the REACH regulation
(Authorization List - Annex XIV)

The manufacture, placing on the market or the use of substances that have been included in the “List of substances subject to authorization - Annex XIV of the REACH regulation” are subject to authorization . An application for approval must be submitted for this.


List of Substances restricted under REACH - Annex XVII of the REACH Regulation

The manufacture, placing on the market or use of substances included in the “List of Restricted Substances - Annex XVII of the REACH Regulation” is either restricted or prohibited .

The admission process

The objectives of the authorization are sufficient control of the risks emanating from substances of very high concern ( SVHC ) as well as the gradual replacement of these substances with suitable alternative substances, provided these are economically and technically viable.

Admission is a three-step process with the following steps:

  • Creating a candidate list,
  • Inclusion in Annex XIV of the ordinance (the substances subject to authorization are listed here),
  • Application for Admission.

For Annex XIV of the REACH regulation, ECHA and the individual member states published a list of dossiers on the proposed substances on June 30, 2008. Comments and objections to this list could be submitted until August 14, 2008. If this right was not exercised, the relevant substance was added to the candidate list. However, if objections are raised, a decision on inclusion in the list of candidates is made in a so-called committee procedure in accordance with Article 133 No. 3 of the REACH Regulation with the involvement of the Commission.

Since June 1, 2009, ECHA has been proposing priority substances for inclusion in Annex XIV at least every two years, taking into account its own capacity for the number of substances [Article 58 REACH Regulation]. The first 15 substances on the SVHC list have been known since October 28, 2008 and can be found on the ECHA website.

The first update took place on January 13, 2010, 14 additional substances were included, the inclusion of the substance acrylamide (CAS No. 79-06-1) recognized as SVHC was temporarily suspended.

The list of substances is published on the Internet so that interested parties have the opportunity to comment for a certain period. After a decision-making process by the Member States and the Commission in accordance with Article 133 No. 4 of the REACH Regulation, a decision is made in the event of comments submitted as to whether the substances will be included in Annex XIV.

The following data are included in Annex XIV [Article 58 No. 1 REACH Regulation]:

  • Identity of the substance;
  • Inherent properties (e.g., carcinogenic, persistent);
  • Transitional regulations such as
  • the expiry date from which the placing on the market and use of the substance are prohibited, unless an authorization has been granted,
  • the time by which an application for admission must be submitted. This must be at least 18 months before the expiry date,
  • if necessary, review periods for certain uses,
  • if applicable, uses or categories of use that are exempt from the authorization requirement.

The application for approval according to Article 62 of the REACH Regulation is submitted to ECHA. Manufacturers, importers or downstream users can submit an application. Among other things, it contains an examination of the alternative possible substances, taking into account their risks and the technical and economic feasibility of substitution , including information about relevant research and development activities of the applicant, if applicable.

The Commission grants or denies approval. According to Article 60 of the REACH regulation, an authorization is granted if the risk to health and the environment is adequately controlled. This is the case if it can be demonstrated that the exposure remains below certain threshold values ( e.g. DNEL value , PNEC value ).

If threshold values ​​cannot be determined or if these are exceeded, approval can only be granted if

  • no suitable alternative substances or technologies are available and
  • the socio-economic (social and economic) benefits outweigh the risk of use.

The restriction procedure

ECHA and the individual Member States can publish proposals for restricted uses of substances in the form of a dossier on the Internet.

The groups affected by a possible restriction can submit a statement, if possible in the form of a socio-economic analysis, within a certain period of time.

After the deadline, ECHA will give the Commission an opinion on whether the restrictions will reduce the risk and what the socio-economic impact will be. The Commission may then adopt the restriction or not.

The restrictions are included in Annex XVII of the REACH regulation.

On February 17, 2011, the EU Commission decided to ban six chemical substances within the next three to five years. These substances are chemicals that are carcinogenic or toxic to reproduction, hardly degrade in the environment or accumulate in living organisms.

Information requirements

Article 31 regulates the information obligation and the disclosure of information on substances and mixtures by means of safety data sheets .

The dissemination of information on substances and mixtures for which no safety data sheet has to be drawn up is regulated in Article 32.

Article 33 of the REACH regulation regulates the information requirements about substances in products within the supply chain and towards private consumers.

The duty to provide information in accordance with Article 33 within the supply chain always applies when a product contains a substance from the candidate list with a weight percentage of 0.1% or more.

All downstream actors within the supply chain must be informed immediately about SVHC in articles. The information consists at least of the name of the substance, it can be supplemented with information on the safe handling of the product.

Consumers have the right to be informed about the SVHCs in products upon request. The German Federal Environment Agency has provided sample letters for inquiries on its website (keyword “New information obligations for companies” from October 28, 2008). A company has 45 days to respond to the request of those affected. The answer must at least contain information about the name of the substance; it can be supplemented with information on the safe handling of the product.

According to Article 34, the duty to provide information also applies in the opposite direction, if z. B. a user has new information about a substance.

According to Article 36, all those involved under REACH must retain the information required for their area for ten years after the last manufacture, introduction, delivery or use.

The schedule at a glance

June 1, 2007 Entry into force of REACH
June 1, 2008 Start of pre-registration
December 1, 2008 End of pre-registration
January 1, 2009 Publication of the pre-registered substances
June 1, 2009 ECHA proposes substances for Annex XIV
December 1, 2010 End of registration period for
Substances ≥ 1000 t / a
CMR substances ≥ 1 t / a
Environmentally hazardous substances ≥ 100 t / a
December 1, 2011 The first work plan for the assessment has been completed
1st June 2013 End of the registration period for substances ≥ 100 t / a
June 1, 2018 End of the registration period for substances ≥ 1 t / a

Business support

To give companies assistance, particularly small and medium-sized enterprises (SMEs), to meet the requirements of the regulation are Member States in addition to those issued by the ECHA materials more technical manuals known as RIP ( R EACH I mplementation P roject) and each national helpdesks provide. The national helpdesk is set up in Germany at the Federal Institute for Occupational Safety and Health  (BAuA), in Austria (www.reachhelpdesk.at) at the Federal Ministry of Agriculture, Forestry, Environment and Water Management  (BMLFUW, Department V / 5, Chemical Policy and Biocides) and is  entrusted by the Federal Environment Agency (UBA).

The following table provides an overview of the RIPs. (Note: At the moment some RIPs are still being processed.)

Overview of the technical guides / RIPs
RIP designation
RIP 1 Detailed description of the REACH process
RIP 2 REACH-IT: Development of the IT system to support REACH implementation
RIP 3 Industry guides
RIP 4 Guides for the authorities
RIP 5 Development of the pre-agency
RIP 6 Structure of the agency
RIP 7 Preparing the Commission for REACH
RIP 8 Guide: Requirements for substances in articles

The guidelines under RIP 3 are intended to provide essential support for companies. RIP 3 is structured as follows:

RIP 3
RIP 3.1 Registration guide
RIP 3.2 Guideline for preparing the chemical safety report
RIP 3.3 Guide to requirements for data on intrinsic substance properties
RIP 3.4 Data Sharing Guide (Pre-Registration)
RIP 3.5 Guide on obligations of downstream users
RIP 3.6 Guide to classification and labeling under GHS
RIP 3.7 Guide to preparing an application for approval
RIP 3.8 Guide to meeting the requirements for articles
RIP 3.9 Guide to preparing a socio-economic analysis
RIP 3.10 Guide to substance identification and naming

The European Commission also provides all companies affected by REACH with IUCLID, an IT application that can be downloaded free of charge and is used for user-friendly recording of the substance data required by REACH.

In addition, numerous service providers such as engineering offices, larger companies or clubs and associations offer their support in implementing the EU chemicals regulation.

criticism

Above all, German industrial representatives criticize the set of rules for the fact that the investigations and the hedging of possible risks generate high expenses, which are disproportionately high, especially for small and medium-sized companies, and lead to significant competitive disadvantages. Industry representatives from countries outside the EU criticize the fact that the regulations can restrict the export of chemicals to the EU.

A major point of criticism from all European trade associations is that REACH primarily affects companies manufacturing within the EU and thus leads to a competitive disadvantage compared to importing companies. There is fear of massive migration of branches of production.

In addition, it is to be feared that various substances will no longer be available in the EU after the entry into force of REACH, as the suppliers shied away from the costs of registration. The semiconductor industry in particular could be affected by this, since only a relatively small percentage of world production is located in Europe and the effort for registration will be high relative to the amount that can be sold.

In the practical application of the REACH regulation, the aforementioned fears have largely proven to be unfounded, as shown by extensive studies that the European Commission commissioned as part of the first evaluation of the regulation (“REACH review”).

Opponents of animal experiments criticize the fact that data from animal experiments are also recognized as test results. The Doctors Against Animal Experiments that REACH will have an increase in animal testing figures result go, according to a press release from the assumption, and question the applicability of the results of animal studies to humans. In contrast, however, 86% of animal experiments in the pharmaceutical sector relate to chemical safety tests, and their results are regularly recognized by regulatory authorities, science and the majority of medical professionals.

In August 2018 it became known that many dossiers were inadequate: a random check by the Federal Environment Agency and the Federal Office for Risk Assessment showed that incorrect data were entered in at least one third of the dossiers for high-volume substances (production or import> 1000 tonnes / year) or data was completely missing. Despite requests for improvement by ECHA, certain dossiers were not completed. However, the substances concerned remained on the market. Members of Bündnis 90 / Die Grünen in the European Parliament called this the “diesel gate of the chemical industry”.

Examples of different chemical inventories

  • AICS - Australian Inventory of Chemical Substances
  • DSL - Canadian Domestic Substances List
  • NDSL - Canadian Non-Domestic Substances List
  • KECL - Korean Existing Chemicals List
  • ENCS (MITI inventory) - Japanese Existing and New Chemical Substances (see Chemicals Law (Japan) )
  • PICCS - Philippine Inventory of Chemicals and Chemical Substances
  • TSCA - Toxic Substances Control Act (since 1976)
  • IECSC - Inventory of Existing Chemical Substances Produced or Imported in China
  • NECI - National Existing Chemical Inventory in Taiwan
  • NZIoC - New Zealand Inventory of Chemicals
  • Poison List - Swiss Poison Lists 1-3 (until 2005)

See also

literature

  • Florian Ammerich: The registration procedure according to REACH-VO in the light of European self-administration law. Duncker & Humblot, 2014, ISBN 978-3-428-14448-8 .
  • Astrid M. Funke: Basic problems with the authorization of particularly dangerous substances in the REACH regulation. Nomos Verlag, 2008, ISBN 978-3-8329-3084-4 .
  • Christian Calliess , Martina Lais: REACH revisited - The proposal for a regulation to reform chemical law as an example of a new European precautionary strategy. In: Nature and Law. 27, No. 5, 2005, pp. 290-299, ISSN  0172-1631 .
  • Henning Friege: REACH - Registration, Evaluation and Authorization of Chemicals - level of information about the properties of chemicals controversial. In: Environmental sciences and pollutant research. 17, No. 3, 2005, p. 184, ISSN  0934-3504 .
  • Martin Führ : REACH practical manual (659 pages), 2011, ISBN 978-3-452-27377-2 .
  • Martin Führ: Pit stop for the REACH regulation. In: Journal for Environmental Law. (ZUR) 2014, pp. 270-280 and 329-33, ISSN  0943-383X .
  • Lothar Knopp: REACH versus “better regulation” and harmonization. In: Environmental and Planning Law. 25, No. 11 + 12, 2005, pp. 415-418, ISSN  0721-7390 .
  • Uwe Lahl, Katrin Anne Hawxwell: REACH - The New European Chemicals Law. In: Environmental Science & Technology . 2006, pp. 7115-7121, doi: 10.1021 / es062984j .
  • Steffi Richter, Dietline Großmann, Caroline Hoffmann (eds.): REACH for users. Brochure, 34 pages. Federal Environment Agency Dessau.
  • P. Brandhofer, K. Heitmann: REACH - The new challenge for your company. Ecomed Verlag, ISBN 978-3-609-65104-0 .
  • M. Au, R. Rühl: REACH regulation. Berlin, ISBN 978-3-503-10332-4 .
  • K.-H. Lang, A. Saßmannshausen, A. Schäfer, K. Nolting: Final report on the pilot project REACH-Net - long version -. Wuppertal 2007, ISBN 978-3-936841-13-8 .
  • Cornelia Boberski (Ed.): REACH manual. Forum Verlag, Merching 2007, ISBN 978-3-86586-126-9 .
  • Karsten Aldenhövel: REACh declared! Norderstedt 2007, ISBN 978-3-8334-9991-3 .
  • Fluck, Fischer, von Hahn: REACH + substance law. Comment, loose-leaf. Berlin 2007, ISBN 978-3-939804-27-7 .
  • Michael Au, Reinhold Rühl: Reach - Regulation - Explanations of the most important regulations for operational practice - With facts and backgrounds to the new European chemicals policy. Erich Schmidt Verlag, Berlin 2007, ISBN 978-3-503-10332-4 .
  • Horst von Holleben: Legal and contractual data sharing according to REACH. In: Führ, Wahl, von Wilmowsky (Hrsg.): Environmental law and environmental science - Festschrift for Eckehard Rehbinder. Erich Schmidt Verlag, Berlin 2007, ISBN 978-3-503-10008-8 .
  • Fabienne Köller: The reform of the European chemicals law REACH in the light of the precautionary principle under Community law, at the same time a treatment of the essential legal problems of the REACH regulation according to the Commission proposal of October 29, 2003. Frankfurt 2006, ISBN 978-3-631-55658-0 .
  • Fritz Kalberlah, Markus Schwarz, Dirk Bunke, Johanna Wurbs: Polluted products in the consumer sector: Will REACH lead to improvements? In: Environmental Sciences and Pollutant Research. Volume 22, Issue 3, 2010, pp. 188-204, ISSN  0934-3504 .
  • Herbert F. Bender: Safe handling of hazardous substances under consideration of REACH and GHS. 4th edition. Wiley-VCH, Weinheim / Bergstrasse 2011, ISBN 978-3-527-32927-4 .
  • Gabriele Janssen : The safety data sheet according to REACH. Qualification of the creator - requirements of the ECHA guidelines and national requirements. 5th edition. ecomed Sicherheit, Landsberg 2013, ISBN 978-3-609-65129-3 .

Web links

Help desks

Germany:

Austria:

Switzerland:

Individual evidence

  1. ↑ Article 141, paragraph 2: "Titles II, III, V, VI, VII, XI and XII as well as Articles 128 and 136 shall apply from June 1, 2008."
  2. ↑ Article 141, paragraph 3: "Article 135 shall apply from August 1, 2008."
  3. ↑ Article 141 (4): "Title VIII and Annex XVII shall apply from June 1, 2009."
  4. ↑ Regulation (EC) No. 1354/2007 , Regulation (EC) No. 987/2008 , Regulation (EC) No. 1272/2008 , Regulation (EC) No. 134/2009 , Regulation (EC) No. 552/2009 , Regulation (EU) No. 276/2010 , Regulation (EU) No. 453/2010 , Regulation (EU) No. 143/2011 , Regulation (EU) No. 207/2011 , Regulation (EU) No. 252/2011 , Regulation (EU) No. 253/2011 , Regulation (EU) No. 366/2011 , Regulation (EU) No. 494/2011 , Regulation (EU) No. 109/2012 , Regulation (EU) No. 125/2012 , Regulation (EU) No. 412/2012 , Regulation (EU) No. 835/2012 , Regulation (EU) No. 836/2012 , Regulation (EU) No. 847/2012 , Regulation (EU) No. 848/2012 , Regulation (EU) No. 126/2013 , Regulation (EU) No. 348/2013 , Regulation (EU) No. 517/2013 , Regulation (EU) No. 1272/2013 , Regulation (EU) No. 301/2014 , Regulation (EU) No. 317/2014 , Regulation (EU) No. 474/2014 , Regulation (EU) No. 895/2014 , Regulation (EU) 2015/282 , Regulation (EU) 2015/326 , Regulation (EU ) 2015/628 , Regulation (EU) 2015/830 , Regulation (EU) 201 5/1494 , Regulation (EU) 2016/26 , Regulation (EU) 2016/217 , Regulation (EU) 2016/863 , Regulation (EU) 2016/1005 , Regulation (EU) 2016/1017 , Regulation (EU) 2016 / 1688 , Regulation (EU) 2016/2235 , Regulation (EU) 2017/227 , Regulation (EU) 2017/706 , Regulation (EU) 2017/999 , Regulation (EU) 2017/1000 , Regulation (EU) 2017/1510 , Regulation (EU) 2018/35 , Regulation (EU) 2018/588 , Regulation (EU) 2018/589 , Regulation (EU) 2018/675 , Regulation (EU) 2018/1513 , Regulation (EU) 2018/1881 , Regulation ( EU) 2018/2005 , Regulation (EU) 2019/957 , Regulation (EU) 2019/1691 , Regulation (EU) 2020/171 , Regulation (EU) 2020/507 , Regulation (EU) 2020/878 , Regulation (EU) 2020/1149
  5. ↑ Article 67 i. V. m. the lists in Annex XVII; Violations in Germany are e.g. Partly punishable according to §5 Chemical Sanctions Ordinance i. V. m. Section 27 (1) of the Chemicals Act or unlawful according to Section 6 of the ChemSanctionsV i. V. m. Section 26 (1) No. 11 of the ChemG.
  6. ↑ REACH regulation. Art 3, No. 1.
  7. ↑ Registration on the UBA website reach-info.de, accessed on May 7, 2015.
  8. ↑ ECHA: Pre-registered substances .
  9. ↑ Information from ECHA .
  10. ↑ Information from the BDI on REACH (Site 13) ( Memento from May 17, 2012 in the Internet Archive ).
  11. ↑ The New European Union Chemicals Regulations NR&E Winter 2009 (English)
  12. ^ Chemicals Watch. No. 13, December 2008 / January 2009.
  13. ↑ News Alert; ECHA / NA / 11/42 , accessed October 19, 2011.
  14. ↑ ECHA: REACH registration results - All REACH registrations since 2008 , accessed on June 6, 2018.
  15. ↑ REACH regulation. Art. 14, Para. 4.
  16. ↑ ECHA: Registered substances .
  17. ↑ ECHA: Manual for the submission of data ( Memento of December 3, 2013 in the Internet Archive ) (PDF; 1.6 MB) - Part 16 - Confidentiality requests: Instructions for creating and justifying requests for confidential treatment in accordance with Article 119 Paragraph 2, ECHA, version 2.0 (July 2012).
  18. ↑ ECHA: Registered substances , accessed on December 8, 2017.
  19. ↑ Martin Scheringer (2013): Fragile Evidence: Data Problems in Risk Assessment for Chemicals. Technology assessment - theory and practice, 22nd year, volume 3
  20. ↑ a b Martin Führ : Pit stop for the REACH regulation , Zeitschrift für Umweltrecht 2014, pp. 270–280 and 329–333, ISSN  0943-383X .
  21. ↑ Regulation (EU) 2020/507 of the Commission of 7 April 2020 amending Regulation (EC) No. 1907/2006 of the European Parliament and of the Council with regard to the percentage of registration dossiers to be selected for checking compliance with the requirements
  22. ↑ List of substances of very high concern for authorization .
  23. ↑ List of substances subject to authorization - Annex XIV of the REACH regulation .
  24. ↑ List of restricted substances - Annex XVII of the REACH regulation .
  25. ↑ Chemicals (REACH): Six dangerous substances are being gradually banned by the EU. Press release of the European Commission of February 17, 2011.
  26. ^ Website of the Federal Environment Agency on REACH .
  27. ↑ REACH glossary , reach.sgs.com - the RIPs are listed.
  28. ↑ REACH Implementation Project 3) Guidance Documents for industry (RIP3) on the website of the European Commission .
  29. ↑ Press release Press release: Doctors Against Animal Experiments ( Memento from September 28, 2007 in the Internet Archive )
  30. ↑ VFA position paper on animal experiments in pharmaceutical research
  31. ↑ Federal Office for Risk Assessment: Data quality in registration dossiers. (PDF) In: REACH Compliance Project. BfR, 23 August 2018, accessed on 29 October 2018 .
  32. ↑ The Dieselgate of the Chemical Industry - The systematic violation of current EU law puts health at risk - Sven Giegold - Member of the Green Group in the European Parliament . In: Sven Giegold - Member of the Green Group in the European Parliament . October 26, 2018 ( sven-giegold.de [accessed October 29, 2018]).