REACH stands for Registration Evaluation and Authorization of CHemicals. It is a single, coherent European Chemical Control Regulation [(EC) No 1907/2006)] that became law on 01 June 2007 and is a legal instrument in all 28 European Union Member States (Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom*, Bulgaria and Romania) and in the European Economic Area countries of Norway, Iceland, Liechtenstein. Further, several overseas territories of EU Member States are subject to REACH. The European Chemicals Agency (ECHA) is responsible for implementing the legislation, and enforcement is the responsibility of each of the Member States.
REACH requires industry to be responsible for the safe manufacture and use of chemical substances. Manufacturers/Importers must register all in-scope substances manufactured/imported in quantities of 1 metric tonne or more per manufacturer/importer. It applies to all chemicals, both new and existing, and includes chemicals on their own, within mixtures, and within articles where they are intended to be released. The REACH process consists of pre-registration of eligible chemicals, followed by registration and evaluation, which are used in consideration of the need to follow the risk management options within REACH, namely authorization and restriction.
*The United Kingdom invoked Article 50 of the Lisbon Treaty on 29 March 2017 meaning the UK is scheduled to leave the EU on 29 March 2019 following agreement on the terms of withdrawal from the EU. REACH implications of this action have yet to be resolved and Lubrizol is monitoring developments in this area.
The only actors in the supply chain with registration obligations are:
Yes. Lubrizol has actively prepared for the implementation of REACH since well before its implementation. We developed a comprehensive inventory of eligible substances included in the products we produce in the EU or import into the EU and pre-registered these substances before the November 30, 2008 deadline and since then we have been actively monitoring all of our substances to ensure we maintain compliance with pre-registration and registration obligations. Lubrizol has actively participated or led SIEF (Substance Information Exchange Forum) activities and has registered all eligible substances by the assigned deadlines within the phase-in periods of REACH. Lubrizol has a strong REACH Governance structure that has, amongst other things, developed and put in place the systems and processes to ensure ongoing compliance. Finally, externally Lubrizol has provided significant resources and leadership to develop workable solutions to specific REACH-related challenges.
As noted above we have had a process in place to ensure that all the eligible substances are pre-registered and were registered before the last phase-in deadline of 01 June 2018. As such there has been no interruption in supply of any supported Lubrizol product due to REACH registration requirements. As are many other entities, we are actively engaged in evaluation activities, both dossier and substance evaluations, that impact Lubrizol chemistries. At this time, no Lubrizol substances are subject to authorization but we are monitoring developments in this area.
We have worked closely over more than a decade with both our EU and non-EU suppliers to understand their intent concerning the REACH registration of substances we purchase. We are confident that the supplier risk is acceptably low and have a proactive program in place to understand REACH supply related issues.
Many people at Lubrizol are involved in the REACH activities. Therefore, we ask you to contact your Sales Representative for any questions concerning REACH. For Only Representative services please email Only.Representative@lubrizol.com.
Pre-registration was the first key phase of REACH that took place between 01 June and 01 December 2008. Providing substances met the criteria for what was known in REACH as 'phase-in' status, a company submitted a pre-registration to the ECHA for those substances and received a pre-registration number. The advantage of doing this was that it allowed companies to delay the registration of these 'phase-in' substances until 01 December 2010, 01 June 2013 or 01 June 2018 depending on the volume imported and/or manufactured.
It is important to note that the 'phase-in' period of REACH ends on 01 June 2018, after which time registration will be required for any substance an importer/manufacturer did not already register, prior to supply at ≥ 1 tpa.
There are a vast number of resources available. The most complete and authoritative would be ECHA's website (https://echa.europa.eu). There are also several trade organizations or member state authorities that post REACH related information.
Yes. Lubrizol has been registering its phase-in substances at the appropriate deadline during the 10 year phase-in period. The deadlines were largely based on substance volumes, so some were registered as early as 01 Dec 2010, others 01 June 2013 and the latest deadline for lower volume substances was 01 June 2018.
Lubrizol will continue to register additional substances to those registered within the phase-in period as necessary before supplying at ≥ 1 tpa. We will also continue to update our existing registrations as necessary.
Companies need to track the volume of each in-scope registerable substance on a legal entity specific basis for all EU manufacture and import. All registrations are to be completed in conjunction with other companies registering the same substance in a SIEF (Substance Information Exchange Forum). SIEF participants work together to agree on data sharing, cost sharing and dossier development in order to submit a joint registration to ECHA at the appropriate deadlines. While information was shared among the members of the SIEF, each member had to submit their own registration dossier and pay the appropriate fee to the ECHA in order to continue manufacture and/or import. SIEF members are expected to continue to work together during through the evaluation, either dossier or substance, activities of REACH.
Following the last phase-in deadline of 01 June 2018, data sharing and avoidance of unnecessary testing remains a requirement of REACH.
Registration numbers are communicated down the supply chain to prevent the duplication of registrations. Registration numbers can be found in section 1 of a Safety Data Sheet (SDS) for a substance or in section 3 for those substances, classified as hazardous in a mixture. Any new registration number obtained by Lubrizol is included in SDSs when these documents undergo a major change.
When Lubrizol formulates a mixture, the part of the registration number referring to the individual registrant of a joint submission, the last four digits, is omitted in SDSs in accordance with Annex II of the REACH Regulation. If an authority responsible for REACH enforcement requests your company to provide the full registration number of a substance contained in a Lubrizol product, please forward this request to firstname.lastname@example.org with the contact details of the inspector within 7 days and inform the enforcement authority that you have forwarded their request to Lubrizol. We will provide the full registration number directly to the authority within 7 days.
For all other substances not disclosed in SDSs, we will provide you with the assurance that those substances requiring registration that we manufacture in the EU or import into the EU are registered; for further information, see REACH Update.
Substance registration begins at ≥ 1 tpa per legal entity (i.e. your importer). The EU importer must review the annual volume of each individual substance in the product(s) they import to determine if they have a registration responsibility.
EU customers who source and blend their products in Europe need to ensure that their EU suppliers hold a valid registration for all REACH relevant substances in the product. All Lubrizol products supplied from our EU facilities hold the necessary valid registrations for all in-scope substances contained within them.
Additionally, downstream users need to ensure that registrations include their intended use.
Yes. You have to register these substances yourself if you wish to import at ≥ 1 tpa. Each EU importer, EU manufacturer or Only Representative appointed by a non-EU manufacturer/formulator requires a registration to allow for supply of a substance at ≥ 1tpa. The legislation makes it clear that individual importers cannot rely on the fact that the substance has been registered by someone else if they did not submit a registration themselves.
Yes, as mixtures may contain substances from several different suppliers, there could be several Only Representatives covering portions of that mixture being received by the EU importer. Further, the EU importer may be receiving products from several different non-EU exporters which would also increase the possibility of different Only Representatives being involved.
Note, however, that the appointing non-EU manufacturer or formulator can only assign one Only Representative per substance.
If, as a downstream user, you use the substance outside the conditions communicated to you in the extended safety data sheet (eSDS), or the use is not covered in the eSDS, you may choose one of the following options:
Downstream users are also required to communicate up the supply chain any new information on the hazardous properties of the substances as well as any other information that might call into question the appropriateness of the risk management measures identified in the eSDS.
Substances that are on the Candidate List of SVHCs and present in Lubrizol products above the regulatory threshold of 0.1% wt. will be communicated via the EU SDS and so there is no need for downstream users to request statements about the "absence of SVHCs" each time the Candidate List is updated. Relying on the existing supply chain communication channels allows Lubrizol to comply with all the downstream user obligations related to substances in the Candidate list.
The inclusion of a hazardous substance on the Candidate List does not automatically imply that the substance poses a risk in a specific use and it does not create any immediate limitations on the use of the substance. Inclusion on the list does not affect the Classification and Labelling of the substance or of a mixture containing the substance, and does not require supply chain communication beyond those for any other hazardous substance other than where supplied within articles.
Authorization is a REACH process which aims to ensure that the risks of certain hazardous substances are properly controlled, and that these substances are progressively replaced by alternatives. Annex XIV of REACH is the list of substances subject to Authorization, commonly known as the Authorisation List. Substances contained on the Authorization List are selected from the Candidate List of substances.
Substances included in Annex XIV are regulated such that their specific use must be authorized, to minimize exposure to humans or the environment. After the "sunset date" listed in Annex XIV, companies in the EU must not use a listed substance or supply it for use in the EU unless a specific authorization to do so has been granted within their supply chain. In some cases, use of a listed substance if the use is exempt or a valid authorization application is pending.
The CoRAP, Community Rolling Action Plan, addresses substances which are suspected of posing risk to human health or the environment. Substance Evaluation is the process under REACH that allows for clarification of such suspected risks of those CoRAP listed substances. During Substance Evaluation further information may be requested from the registrants of the substance if additional data is considered necessary to clarify the suspected risk. The evaluation may result in a confirmation of the suspected risk or, alternatively, it may conclude that the substance does not constitute a risk and no further data is needed.
Registration begins at 1 tpa per legal entity so for imports of less than 1 tpa of an individual substance, registration is not required. Polymers are also exempt from registration. However, if the monomer units comprising the polymer backbone (i.e. in combined / polymeric reacted form) calculate to ≥ 2% mass of the polymer and calculate to being imported at ≥ 1 tpa, then the starting monomers are NOT exempt.
The provisions for registration do not apply to substances such as radioactive substances, those under customs supervision, non-isolated intermediates, substances within a transport process, waste, and to substances with certain sector specific product uses.
There are also a limited number of low risk substances that are exempted from registration (including for example naturally occurring substances such as water, rape seed oil, soybean oil etc.) These cases are described in Annexes IV and V of the REACH Regulation.
See the answer to the exemption question above. If these do not apply to your situation there is an exemption for substances imported for Scientific Research & Development activities (e.g. analysis) or for PPORD, Product and Process Oriented Research & Development, which is defined as any scientific development related to product development such as pilot plant/manufacturing or production trials.
Approved active substances for use in biocidal products are regarded as already registered where:
The active substance has been approved in accordance with Regulation (EU) No 528/2012 (BPR), or the active substance is under assessment in the review program of existing active substances established under Article 16(2) of Directive 98/8/EC and continued under Article 89 of BPR.
It is important to note that only the quantities of the approved active substance for use in biocidal products are considered registered under REACH. Thus, if the substance is not used as an active ingredient in a biocidal product, then the exemption would not apply and the quantity of the substance for the non-biocidal use would have to be REACH registered.
Only active biocidal substances can be regarded as registered and so other substances within the biocidal product are subject to registration.
An article is an object that has a specific shape, surface or design that is more important to its function than its chemical composition. Providing that your product meets this description and the substance is not intended to be released under normal or reasonably foreseeable conditions of use, you have no registration responsibility. Otherwise, if the total annual import volume of any individual substance that is intentionally released from the article exceeds 1tpa, then the importer would have to register that substance.
Note that it is possible that while a substance within an article is exempt from registration, an SVHC listing could still require REACH related supply chain communication and potential notification.
ECHA has posted guidance on their website regarding the REACH registration obligations of EU importers of articles. which can be found here: https://echa.europa.eu/documents/10162/23036412/articles_en.pdf/cc2e3f93-8391-4944-88e4-efed5fb5112c.
A substance is intended to be released from articles if it fulfils an accessory function which would not be achieved if the substance was not released. A scented children's toy, for example, is an article with intended release of substances, because fragrance substances contained in the toy are released in order to fulfil an accessory function, namely to scent. Consequently, the release of a substance because of ageing of articles, because of wear and tear or as an unavoidable side-effect of the functioning of the article, is generally not considered as an intended release, as the release as such does not provide a function in itself.
An intended release of a substance from an article has furthermore to occur under normal or reasonably foreseeable conditions of use. This means that the substance release has to occur during the service life of the article. Hence, a substance release during the production or disposal phase of the article's life cycle is not an intended release. Similarly, a release in an accident or due to any form of misuse which is not in accordance with the use instructions of the article, does not occur under normal or reasonably foreseeable conditions of use and is therefore not considered to be an intended release.
You need to rely on your upstream supplier in your supply chain. It is recognized that REACH will result in a significant increase in both upstream and downstream communications over time.
A downstream user can use and place on the market, without limitation any batches of the substance that were supplied to him before his supplier's registration deadline passed.
Our SDSs have been adapted according to the REACH requirements and are updated as new information from REACH registrations becomes available. An up-to-date version can be retrieved at any time from our extranet at my.Lubrizol.com.
Under REACH, the EU Importer has the legal obligation to register all of the non-exempt substances contained in a mixture or article coming into the EU if imported at ≥ 1tpa. Alternatively, the non-EU manufacturer or formulator can appoint an EU-based 'Only Representative' to take on these responsibilities, in which case the EU Importer becomes the downstream user of the imported product. Contact your Lubrizol Account Manager or OnlyRepresentative@Lubrizol.com for more details.
REACH applies to EU manufacturers/importers of individual chemical substances. Manufacturers/Importers must register all substances manufactured/imported in quantities of ≥ 1 tpa or more per manufacturer/importer.
There is no obligation to register mixtures or polymers under REACH but each individual substance in the mixture and the monomer building blocks of the polymers must be registered by the EU manufacturer/importer their Only Representative, unless the substance is exempt from registration, or below the registration threshold quantity.
No. Only products imported in the EU are affected by REACH. Products produced and sold outside of the EU are unaffected.
The only exception is if you are using substances or mixtures exported from the EU to make your product. You will need to work with your EU supplier to make sure their product will still be available.
Any product produced outside the EU and intended for an EU-based customer must be transported across EU borders (customs) by a named importer domiciled in the EU. This person or company is called the Importer of Record. The importer could be the EU subsidiary of the non-EU customer, an EU-based distributor, or an EU-based customer. It could also be a third-party representative/agent, an EU legal entity, acting on behalf of the non-EU customer.
An importer is responsible for registering each substance in the product that is imported at ≥1 tpa. Once the substance has been registered, a unique registration number for each substance will be received from ECHA.
Registration does not complete all of the REACH requirements for importers; they have other activities including tracking the annual import or manufacturing volume and updating their registration dossier if and when new data for the substance becomes available.
Polymers are exempt from registration. However, if the monomer units comprising the polymer backbone (i.e. in combined / polymeric reacted form) calculate to ≥ 2% mass of the polymer and calculate to being imported at ≥ 1 metric tonne per annum, then the starting monomers are NOT exempt.
The same is true for other non-monomer reactants linked onto the polymer; if these other reactants on the polymer structure comprise ≥ 2% mass of the polymer, then these non-monomer reactants must be registered. This requirement has introduced significant complexity in determining and tracking the compliance status of imported polymers and customers wanting to import products containing polymers in the EU should seek expert advice, or work with a knowledgeable industry partner such as Lubrizol.
This document contains guidance on REACH explaining the REACH obligations and how to fulfill them. However, users are reminded that the text of the REACH regulation is the only authentic legal reference and that the information in this document does not constitute legal advice. The European Chemicals Agency does not accept any liability with regard to the contents of this document." (1)
(1) ECHA Guidance on requirements for substances in articles; Version 2 April 2011"
This document is provided for information purposes only and does not constitute legal advice. While every effort has been made to ensure the accuracy of the information contained herein, The Lubrizol Corporation cannot be held liable for any errors in or any reliance upon this information.