Preparing for the REACH regulation is a challenge for many companies, not only chemical companies. Trading companies also need to tackle the new challenges now in order to ensure that they will remain capable of supplying their customers in the future.
REACH Advice GmbH was founded in 2008 to assist especially trading companies in fulfilling their requirements of REACH. REACH Advice GmbH offers advice which has been specifically tailored to meet the needs of trading companies, and operates as a decisive factor in their daily business, not only in relation to their fulfillment of REACH: it is also an important factor in guaranteeing that their customers receive totally compliant and reliable deliveries.
News - Unternehmen
How will the UK withdrawal affect your business?
REACH Advice GmbH, 15.01.2019
"The ayes to the right 202, the noes to the left 432." The Prime Minister's Brexit deal which sets out the terms of Britain's exit from the EU on 29 March was voted down. What does this mean related to REACH? Article 3 (7) of the REACH Regulation establishes that a registrant must be a manufacturer or importer of a substance. Article 3 (4), (9) and (11) stipulates that registrants must be established in the EU. After 30 March 2019, the UK will no longer be a Member State of the EU. Hence, any UK-based company can no longer be a registrant. For the purpose of the EU’s REACH Regulation, any registration by such a registrant will therefore be regarded as non-existent (if no solution could be found until March 29). REACH Advice GmbH helps UK-based companies as their service provider and as Only Representative to transfer and safe the existing REACH registrations.
Brexit does not mean to leave the European chemicals and metal market! Send us a note!
Recommendations suggested based on the results of the enforcement project
REACH Advice GmbH, 18.12.2018
Serious shortcomings in the quality of the information in the chemical safety report were observed and relayed down the supply chain. The non-translation of the extended SDSs into the language of the Member States where the substance was placed on the market had the highest non-compliance rate (12 %, 297 cases). This is no surprise as tools to translate exposure scenarios into the European languages are not commonly available and exposure sceanrios are very often overfreighted by long text passages. Recommendations given in the report are
- Registration dossiers and the associated chemical safety reports should periodically updated.
- Clear and practical, use-specific and self-explanatory risk management measures should be supported in the chemical safety report and the corresponding exposure scenarios.
- Tools for improving the quality of the exposure scenarios/extended SDSs should be used.
- Downstream user should provide feedback to their suppliers on incorrect or inappropriate information in the extended SDS.
REACH Advice GmbH is ready to assist companies to update the existing exposure scenarios and to prepare extended safety data sheets in all European languages. Send us a note!
REACH came into force on 1st June 2007. All producers and importers who will place so called "substances", "preparations" or "articles with an intended release of substances" on the European market* need to prepare for REACH compliance. Companies who ignore REACH may not only breach the law, they may also face loss of business due the fact that substances which have not have been pre-registered cannot be produced or imported after 1st December 2008. If a company carries out one of the following activities, REACH must be observed:
- Manufacturing substances in the European Community* in amounts of 1 tonne or more per year
- Importing substances in their natural form or importing substances in preparations in amounts of 1 tonne or more per year from non-EU countries
- Importing articles containing substances which are intended to be released (and present in all those articles in quantities of 1 tonne or more per year)
* REACH is a Regulation that directly applies in all Member States of the European Union. REACH has been incorporated into the Agreement on the European Economic Area (EEA). This means that REACH also applies in Iceland, Liechtenstein and Norway.
Articles are not required to be registered under REACH. However, there is a duty of notification to ECHA on so-called substances of high concern (e.g. carcinogenic substances or substances that change the genotype or endanger reproduction) if they are contained in an article. This duty is obligatory in the following circumstances:
- the substance was added to the so-called list of candidates
- more of 0,1 % (w/w) of the substance is contained in the article
- the substance is contained in all articles in overall volumes of more than one metric ton per year and per producer or importer, and
- the substance can not be safely isolated in the finished product during its lifecycle and the substance was not registered for this article.
Substances of very high concern must be notified from June 1, 2011 or six months after the substance was added to the list of candidates. A further information duty becomes valid right after a substance has been added to the list of candidates:
Suppliers must inform their customers immediately about these substances of high concern in articles where they appear in a concentration of more than 0.1% (w/w), and must submit all information they possess to their clients in order to ensure safe usage of the product. If the consumer requests information on the substances of very high concern, suppliers must also deliver this information within 45 days of the consumer’s request.
The list of candidates appears at this link: https://echa.europa.eu/candidate-list-table. It is updated continuously, therefore all parties in the supply chain should be especially diligent.
All over the world there are different laws on how to identify the hazardous properties of chemicals and how the information about these hazards is then passed to users. This might cause confusion due to the fact that different countries may apply different hazard descriptions to the same chemical. In order to address this confusion the United Nations created the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
European CLP Regulation
CLP Regulation 1272/2008/EC on Classification, Labelling and Packaging of substances and mixtures implements the GHS into European law. As a regulation, no further implementation into national law is required. CLP entered into force on 20 January 2009.
Manufacturers and importers who place substances on the market will have to notify certain information to the Classification and Labelling Inventory.
Classification & Labelling Inventory
The Classification & Labelling (C&L) Inventory (the “Inventory”) is a database which will contain basic classification and labelling information on notified and registered substances which have been received from manufacturers and importers. It will also contain the complete list of harmonised classified substances in Europe. The Inventory will be established and maintained by the European Chemicals Agency (ECHA).
It is a complex task to register substances under REACH or to classify substances according to CLP. Moreover, it's extremely time-consuming. REACH Advice GmbH offers to support and help you deal with all aspects of the registration, be it the whole registration process or single parts of it. Our services comply the areas of REACH, CLP and Legal Compliancy Services.
REACH regulation is a challenge for industry as a whole. A team of experts is needed for all parts of the registration process to achieve successful registration. This can be achieved by skilful management, and the implementation of programs and strategies to monitor the substances' compliance with the regulation. In doing so, companies ensure in advance that the complex regulations of REACH registration are entirely fulfilled.
The registration includes the collection and assessment of information on the attributes of substances. The amount of information that is needed for this relates to the hazards and tonnage of the substance which is to be registered.
After you have set up your expert-team we will train them on:
- Preparing supplier questionnaires on the availability of raw materials in the future
- Communication with suppliers and customers on use and exposure categories
- Complying with the legal requirements of the REACH regulation and European member states' legislation.
- Representation and consulting in a SIEF/consortium
- Registration management including compiling technical dossier, exposure scenarios, chemical safety reports and extended safety data sheets (in all European languages)
- Creation and updating of IUCLID 6 dossiers
- Handling of registration dossiers
- Analysis of your REACH requirements and possibilities
- Supply chain communication
- REACH manager training
- Development of strategies for the REACH process implementation
- Evaluation of REACH impact
- Preparing your company to comply with REACH requirements ("legal compliance management")
After pre-registration, the importers and manufacturers of a substance will establish a SIEF (Substance Information Exchange Forum), the purpose of which is to exchange information on the substance. This forum's main goal is to avoid duplicate testing on the same substance during registration and to share costs and registration work. Moreover it facilitates the labelling and classification of substances.
REACH Advice GmbH will support and represent your company in this forum and in the respective consortia, if desired. We also offer strategic and legal support in the background in the event you would like to you represent yourself.
- Strategic consulting
- Support on all legal matters
- Background consulting
- Support and contact on all matters related to a SIEF or consortium
- Handling all communication with authorities
Our REACH Services
It is a complex task to register substances under REACH. Moreover, it's extremely time-consuming. REACH Advice GmbH offers to support and help you deal with all aspects of the registration, be it the whole registration process or single parts of it.
Are you among the companies that have to deal with REACH?
We will support you with the following services:
- IUCLID 6 data updating
- Handling and completion of registration dossiers
- Economical and financial evaluation of REACH impact
- Evaluation of studies
- Direct communication with your customers, authorities and your co-registrations
- Collection and generating of data
- Creation of chemical safety reports
- Extended SDS with exposure scenarios
- Strategic registration advice
- Representation in SIEF(s) and consortia
- Risk assessment
- Submission of registration dossiers, dossier follow-up
Companies manufacturing substances, preparations or articles and who were established outside the EU cannot pre-register nor register their substances themselves. Instead, they can appoint an Only Representative (OR): the Only Representative is, under the terms of REACH, an EU- based legal representative appointed to represent those non-EU companies during export business into the EU market. He is responsible for the communication of risk in the supply chain and is entitled to represent the manufacturer during registration.
There are several areas in which your company will benefit from the appointment of an Only Representative:
- an OR will make your company independent from importers with an own registration number. This will prevent you from the danger of losing market connection in of the event that one of your EU importers should stop trading with you
- with your OR you will be one step ahead of other suppliers who are not located in the EU and have not appointed an OR for the registration of their substances
- your OR will take the obligation of registration away from the importers you trade with, and in so doing you will keep up a persistent market acess to the EU
Who can you choose to act as OR for your company?
All EU-based legal entities that have sufficient experience in the handling of substances can act as OR.
Importers whose non- EU producers have registered for REACH will not be obliged to register; however, they must confirm with the OR of their suppliers that they are officially listed as the importer and that their OR will cover their tonnage and uses.
REACH Advice GmbH carries out the following tasks as your Only Representative:
- Handle and send Safety Data Sheets (SDS) along the supply chain
- Update Safety Data sheets
- Prepare and submit registration documents and dossiers, and update registration documentation
- Run an importer inventory containing the tonnage that the respective importer covers
- Be prepared to inform the member state authorities on demand regarding the amount and character of the imports into the EU
- Authorisation and registration
- Prepare and examine cost sharing models
- Perform impact analyses
- Spread and control the necessary information within the supply chain
- Take part in and communicate in the respective consortia
- Monitor the consortia
- Take minutes of meetings in the SIEF / consortium
- Observe deadlines
- Negotiate contracts and clarify legal requirements
- Prepare assessments and safety reports
REACH Advicve GmbH can provide you with support in dealing with the signature of a licence agreement (Letter of Access, LOA) with the consortium or registrant. It is crucial for your company to purchase the LOA in order to relate to the requirements of the registration dossier.
We will gather the information that is required to create the individual part of the registration dossier and will arrange the obligatory testing to prove your chemical identity data. As a minimum, we will prepare the individual part of the dossier in IUCLID 6. As it is crucial to submit a complete and error-free dossier in order to pass all the necessary tests during the registration (otherwise ECHA will reject the dossier) REACH Advice GmbH will examine the Technical Completeness of the dossier as soon as it has been fully prepared.
REACH Advice GmbH will submit the dossier on your behalf and at the same time, will clarify -if possible- ECHA's questions during the evaluation phase.
In case you intend to keep your identity undisclosed to the competition or SIEF (Substance Information Exchange Forum) members you can nominate a so-called Third Party Representative (in accordance with article 4 of REACH). REACH Advice GmbH will represent you in the SIEF while you retain full responsibility for the compliance of your REACH obligations. We offer the following services:
- Participation in SIEF including minutes
- Participation in consortia
- On-demand consortia monitoring
- Contracts negotiation
- Verification of cost sharing models
- Representation of EU customers
- Examination and clarification of legal requirements
- Creation of safety reports and risk assessments
- Registration dossier preparation
Our services for fulfilling CLP compliance for you company
Our goal is to offer you a one-stop solution for fulfilling CLP compliance. This includes not only the classification of your single and mixed substances but also the submission of the classification and labelling to the Inventory.
- Consulting on the impact of REACH and CLP for your enterprise
- Classification and labelling of single and mixed substances
- Notification to the Inventory
- Creation of SDS in compliance with both CLP & REACH
Legal Compliancy Services
Changing responsibilitiesThrough a skillful and efficient management of substances and hazardous materials, REACH Advice GmbH can provide you, whether you are a chemical manufacturer, supplier or trader, with the assurance that your products will always comply with current, applicable legislation on their way to the world-wide market. Through REACH Advice GmbH you can order tailored services or an entire outsourcing of hazardous goods management. Our experienced team of experts will consult and support you during the entire process of handling substances, from the purchase of a substance through to product development, registration and handling.
The following services are available:
- Validation of the products' and substances' marketability
- Registration application, listing of substances
- Research and evaluation of substance data
- Classification and labelling of hazardous goods, substances and mixed substances as required by legislation (for example, laws that regulate hazardous goods, transport etc.)
- Creation of SDS (Safety Data Sheets) in compliance to REACH and CLP (GHS) invarious languages
Our aim is to clarify your company's tasks, responsibilities and obligations under REACH. The impact REACH will have on your company is always case-dependent and related to a number of factors. We will put an emphasis on various items including:
- What is your company's position regarding the REACH regulation?
- Which of your company's products are under the scope of REACH and which are under the scope of CLP?
- How hazardous are your substances?
- Is it possible to limit the scope of REACH in the event of a changed sourcing?
In a second step we will evaluate your company's internal structure.
- What tasks can be performed in-house by your staff?
- What items and tasks require external assistance?
- What sort of training measures are required and how often would these measures need to be repeated?
- These procedures will prepare your company for the next steps on your way to REACH registration.
SVHC are substances that can have dangerous and often irreversible impact on human beings or the environment. According to article 57 of REACH, substances that were included into the candidate list are classified as Substances of Very High Concern (SVHC). These substances will be put on the authorization list and their use will restricted by the European Commission.
What does this mean for your company?
The SVHC aspect of REACH affects not only the manufacturers of a substance or product but also its distributors, importers and traders. This of course has a significant impact on your company. The SVHC part of REACH has a business aspect also because it will affect the in-house management of your products and their supply chain, it will stabilize your customers' faith and strengthen your brand.
The services of REACH GmbH include consulting on compliance with the SVHC regulation, strategic support throughout the supply chain and an expert SVHC testing service. REACH GmbH can provide you with individual or tailored services, or a one-stop service package. We can offer SVHC testing for a wide variety of products.
REACH establishes not only a new system in assessing the risk behind the usage of chemicals: REACH will lead to a new responsibility. Legal sanctions may threaten executive bodies and officers on the board of companies or in administrations. For this reason, the demands placed on companies to attend carefully to REACH are dramatically increased compared with the old chemicals legislation. As a result, management is now confronted with a responsibility and liability that is no longer assumed by governmental monitoring agencies and one which cannot be diminished by means of delegation.
Article 126 of REACH regulates the obligation of member states to impose penalties. The EU member states impose several types of penalties Including prison and market withdrawal, however one common feature is the imposition of fines.
To prevent your company from facing any of these penalties REACH Advice GmbH will evaluate your role within REACH and will show you the necessary measures your company will have to carry out in order to be compliant.
REACH applies to all chemical substances, including metals. Therefore, everyone who manufactures in or imports metals from outside the EU above one tonne per year may have registration obligation under REACH. Due to lack of knowledge and transparency many companies are uncertain about the correct procedures and the ultimate costs of REACH. As a consequence, metalshub and the REACH Advice GmbH have entered into a strategic cooperation to support companies in the metals business with REACH. This cooperation has the objectives
- Create more transparency and keep you informed about REACH.
- Make REACH related services easily accessible for metalshub users.
- Provide expert support around registration, representation & compliance.
REACH Advice GmbH are the leading experts to assist especially trading companies in fulfilling their requirements of REACH. Metalshub is a leading digital marketplace for companies buying and selling ferroalloys and metals increasing transparency and efficiency on the metal’s market.
REACH Advice GmbH
Phone + 49 (0) 2441 77 17 602
Fax + 49 (0) 2441 776489
Place of business: Kall, Germany
Managing Director: Ewald Langenohl
Register Court: Düren
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