Frequently Asked Questions

What is REACH?
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 27 European Union Member States (Austria, Belgium, 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 by the following European Economic Area members, Norway, Iceland, Liechtenstein. Further, several territories of France (French Guiana, Guadeloupe, Martinique and Reunion) and one territory of the UK (Gibraltar) are subject to REACH. 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 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 used in industrial processes but also products. Its process consists of pre-registration of chemicals, followed by Registration and Evaluation, followed by Authorization and Restriction of Chemicals.

Who is Responsible for REACH?
The only actors in the supply chain with registration obligations are:

• EU manufacturers and importers of substances on their own or in preparations (mixtures);
• EU producers and importers of articles meeting the criteria explained in the Guidance for articles;
• “Only Representatives” established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU to fulfill registration obligations of importers.

Does Lubrizol understand the REACH legislation and have adequate plans and resources to ensure timely compliance?
Yes. Lubrizol actively prepared for the implementation of REACH. We developed a comprehensive inventory of eligible substances included in the products we produce in Europe or import into Europe and pre-registered these substances before the November 30, 2008 deadline. Lubrizol is actively participating or leading SIEF (Substance Information Exchange Forum) activities and planning to register the eligible substances by the assigned deadlines. Lubrizol has a strong REACH Management Team that has developed and put in place the systems and processes to ensure ongoing compliance. Finally, Lubrizol is providing significant resources and leadership to the petroleum additives industry to develop workable solutions to specific REACH-related challenges.

Can I be assured that there will be no interruption in supply due to REACH requirements?
We have a process in place to ensure that all the eligible substances are pre-registered and will be registered before the deadline and there has been no interruption in supply of any Lubrizol product due to REACH requirement.

Do all the Lubrizol suppliers have adequate plans concerning REACH?
We are working closely with both our European and non-European suppliers to understand their intent concerning the registration of substances we purchase. Based on questionnaires received and interviews with key suppliers, we are confident that the supplier risk is acceptably low.

I’ve heard about pre-registration. What was the purpose of pre-registration?
Pre-registration was the first key phase of REACH that took place between 1st June and 1st December 2008. Providing substances met the criteria for what is known in REACH as 'phase-in' status, a company submits a pre-registration to the ECHA for those substances and receives a pre-registration number. The advantage of doing this was that it allowed companies to delay the registration of these ‘phase-in’ substances until 1st December 2010, 1st June 2013 or 1st June 2018 depending on the volume imported and/or manufactured.

It is important to note that the ‘phase-in’ period of REACH ends in June 2018, after which time registration will be required for any substance an importer/manufacturer did not already register, prior to supply at ≥1tpa.

What are some of the activities associated with the ongoing legal obligations related to substances which are pre-registered and registered?
Companies need to track the annual volume of each substance on a legal entity specific basis for all EU manufacture and import. The tonnage band in which a substance falls determines the data requirements and (for pre-registered substances) the registration deadline. Further, as a pre-registrant of a substance under REACH that wishes to register the substance it is necessary to participate in a SIEF (Substance Information Exchange Forum) with other companies who pre-registered the same substance. Guidance on how SIEFs operate is described in articles within the REACH regulation. The aim is to avoid duplication of studies and to agree on the classification and labeling of the substance. SIEFs involve information sharing, cost sharing and dossier development in order to submit a registration to the ECHA at the appropriate deadline during the phase in period. While information is shared among the members of the SIEF each member must submit their own registration dossier and pay the appropriate fee to the ECHA in order to continue manufacture and/or import.

Can Lubrizol provide the pre-registration numbers and certificates for the products supplied to its customers?
Most of the products that we supply are complex preparations which may contain multiple substances that must be registered. Providing pre-registration numbers and certificates would represent a significant administrative and financial effort without real benefits for the downstream users. We prefer providing you with the assurance that all the substances that we manufacture in the EU or import into the EU are pre-registered and will be registered by the appropriate deadlines; further see http://www.lubrizol.com/REACH/REACH-Update.html.

When will Lubrizol complete the registration of its products?
Lubrizol will be registering its phase-in substances at the appropriate deadline during the 10 year phase-in period. The deadlines are 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 is 01 June 2018.

Which countries are under the jurisdiction of REACH?
While REACH is an EU regulation, the jurisdiction includes all 30 countries of the European Economic Area (EEA) which includes the 27 members of the EU PLUS Iceland, Liechtenstein and Norway. Further, several territories of France (French Guiana, Guadeloupe, Martinique and Reunion) and one territory of the UK (Gibraltar) are subject to REACH. Notably, Switzerland is not subject to REACH.

Do Lubrizol products contain any substances likely to be Substances of Very High Concern (SVHC)?
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 (MSDS) 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.

Additional information is available from Cefic – The European Chemical Industry Council at http://www.cefic.org/Documents/IndustrySupport/Communication_January2011_final.pdf \ See page 2.

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Which substances are currently considered SVHCs?
The current Candidate List and potential obligations associated with SVHCs can be found at http://echa.europa.eu/chem_data/authorisation_process/candidate_list_en.asp.

What is authorization?
Periodically the EU Competent Authorities (CA) will nominate substances to the SVHC Candidate List when sufficient scientific data has been generated to substantiate a risk to human health and/or the environment. Industry has a prescribed amount of time to comment and provide its own data to prove safe use. If no comments are made or they are non-persuasive, the candidates will be listed on the Annex XIV Authorization List and an application for authorization of specific use will need to be submitted by each importer and manufacturer of that substance, regardless of volume unless specifically exempted. All unauthorized uses of these substances will be banned under REACH.

Are any substances in my product exempt from registration?
Registration begins at 1 MT per annum per legal entity so for imports of less than 1 MT of an individual substance, (pre)registration is not required. Polymers are also exempt from (pre)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. There are also a limited number of named naturally occurring substances that are exempted from (pre)registration (such as water, rape seed oil, soybean oil etc.). These cases are described in Annexes IV and V of the REACH Regulation. If there are any other substances contained in a product that do not meet these criteria they do need to be (pre)registered.

I want to send a sample of my product to a European customer for a trial (analysis). Do I have to register all the substances in my product?
See the answer to the exemption question above. If these do not apply to your situation there is an exemption for substances imported for Research & Development activities (e.g. analysis) or for something called PPORD, Product and Process Oriented Research & Development (any scientific development related to product development such as pilot plant/manufacturing or production trials). Usually, there will be no financial remuneration for samples relying on these exemptions.

Where can I go to learn more about REACH?
There are a vast number of resources available. The most complete and authoritative would be ECHA’s website (http://echa.europa.eu). Other sites include http://ec.europa.eu/enterprise/reach/index_en.htm and http://www.cefic.org/Industry-support/Implementing-reach/

What are the contact details of Lubrizol’s REACH coordinator?
Many people at Lubrizol are involved in the REACH activities. However, we ask you to contact your Sales Representative for any questions concerning REACH or email Only.Representative@lubrizol.com.

• John Winslow, REACH Commercial Manager – Additives
• Naser Pourahmady, REACH Commercial Manager – Advanced Materials
• Mel Biring, Manager - Compliance, Europe

What end-use applications will be covered by the registration of Lubrizol products?
As part of the registration process, Lubrizol intends to include commonly known and anticipated end uses of the products in the Chemical Safety Report included as part of the registration dossier.

Downstream users have the right to communicate their uses through the supply chain for consideration and possible inclusion in the Chemical Safety Report. Additional information on supported End Uses of Lubrizol products can be found at www.mylubrizol.com and select the “Safety & Supply” tab, on the pull down menu you will find “REACH Supported End Uses”. If your intended use of products purchased from Lubrizol is different than commonly known or anticipated, you may communicate this anticipated use in accordance with Article 37(2) of REACH to Lubrizol for consideration and possible inclusion for supported end uses.

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What are my downstream user obligations if my use is not covered by the SDS?
If, as a downstream user, you use the substance (as such or in a mixture) outside the conditions communicated to you in the extended safety data sheet (eSDS), or the use is not covered at all in the eSDS, you may choose one of the following options:

• Adapt the conditions of use described in your supplier’s eSDS.
• The conditions of use you have implemented for your specific use are at least as strict as the recommended ones in the eSDS.
• Make your intended use known to the supplier, requesting it be part of supplier’s chemical safety assessment with the aim of making it an identified use. Supplier is not required to accept downstream intended uses.
• Perform your own chemical safety assessment for that particular use and record it in a Chemical Safety Report - CSR (if the total amount used is 1 tonne/year or more). Notify your use, including the information specified in Article 38(2) of the REACH Regulation to ECHA.
• Switch to another supplier of the substance if that supplier covers your specific use in his eSDS.

Each downstream user of a substance or preparation who is supplied with an eSDS must ensure that his use conditions are covered by the exposure scenarios.

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.

Do substances used as biocides have to be registered under REACH?
Approved active substances for use in biocidal products are regarded as already registered, as biocidal products and their active ingredients are covered by Directive 98/8/EC (Biocidal Products Directive).

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 to this other use and the quantity of the substance for the non-biocidal use would have to be REACH registered.

What is CoRAP and is it a part of REACH?
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 the Substance evaluation process further information may be requested from the registrants of the substances 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.

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EU Customers

As a downstream user, how will I know that a substance that I use has been pre-registered?
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 communication over time.

As a downstream user, can I continue using a substance in my inventory if it has not been registered?
A downstream user can use and place on the market, without limitation in time, any batches of the substance that were supplied to him before his supplier’s registration deadline passed.

Do the Safety Data Sheets (SDSs) for the Lubrizol products comply with the new requirements set out by REACH?
Our SDSs have been adapted according to the REACH requirements and will be updated as new information from REACH registrations becomes available. An up-to-date version can be retrieved any time from our www.myLubrizol.com extranet.

I import products into Europe directly from a Lubrizol plant outside of the EU. What are my obligations in respect of REACH?
Under REACH, the EU Importer has the legal obligation to (pre)register all of the non-exempt substances contained in a preparation 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 Only.Representative@lubrizol.com for more details.

Non-EU Customers

Do I have to register my product because of REACH?
REACH applies to EU manufacturers/importers of individual chemical substances. Manufacturers/Importers must register all substances manufactured/imported in quantities of 1 metric tonne or more per manufacturer/importer. There is no obligation to register the mixture or polymer under REACH but each individual substance in the mixture and the monomer building blocks of the polymers has to be registered by the EU manufacturer/importer or his/her Only Representative, unless the substance is exempt from registration, or below the registration threshold quantity.

I only sell my product to customers outside the EU. Do I have to do anything?
No. Only products imported in the EU will be 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 his/her product will still be available.

I produce a finished fluid using Lubrizol products and sell it to a customer who is in the EU. Am I the importer?
Any finished oil (usually a preparation/mixture) produced outside the EU and intended for an EU-based customer has to 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, or even an OEM. It could also be a third-party representative/agent, an EU legal entity, acting on behalf of the non-EU customer.

What does the importer of my product have to do?
As the importer he/she is first of all responsible for pre-registering each substance in the product between 1st June and 1st December 2008, or late pre-registering depending on date and amount of first import, including any diluent oil, and then registering each substance. Registration should be in collaboration with other companies (a SIEF) who are registering the same substance(s). Once the substance has been registered, he/she will receive a unique registration number for each substance from the EU Chemicals Agency. This is not the end of his/her responsibilities though, and they have other activities to take care of after registration has completed, including tracking the annual import or manufacturing volume and updating their registration dossier if and when new data for the substance becomes available.

I’m importing a polymer. Does that have to be registered?
No, 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 (pre)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 like Lubrizol.

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My EU representative only imports a small amount of my product each year. Does he/she still have to register all the substances?
Substance registration begins at 1 MT or greater per annum 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.

I buy substances and mixtures from EU-based suppliers and blend these together at my European plant to produce a product that I sell. What do I have to do under REACH?
EU customers who source and blend or compound their finished product in Europe will have to ensure that their EU suppliers hold a valid registration for all the substances in the product. Additionally, they need to ensure that the registration includes their intended application (e.g. an automotive lubricant) which can be found in Section 1.2 on the (M)SDS. These are known as identified uses and if required will be listed on the supplier’s SDS.

I know other companies will pre-register the same substances I’m importing into the EU so do I have to do anything?
Yes, you have to (pre)-register these substances yourself if importing at ≥1tpa. Only importers, manufacturers or Only Representatives appointed by non-EU manufacturers/formulators, who submit a pre-registration themselves will be able to take advantage of the REACH ‘phase-in’ registration period which lasts up to June 2018. The legislation makes it clear that individual importers cannot rely on the fact that the substance has been (pre)-registered by someone else if they did not submit a (pre)-registration themselves.

Can one EU Importer be covered by multiple Only Representatives?
Yes, as preparations may contain substances from several different suppliers, there could be several Only Reps covering portions of that preparation being received by the EU Importer (as a downstream user in this case). Further, the EU importer may be receiving products from several different non-EU exporters which would also increase the possibility of different Only Reps being involved. However the appointing non-EU manufacturer or formulator can only assign one Only Rep per substance.

I incorporate your product into an article and then ship the finished goods to Europe. What do I have to do?
An article is something that has a specific shape, surface or design that is more important to its function than its chemical composition. Providing your product meets this description and the substance in not intended to be released under normal or reasonably foreseeable conditions of use, you have no registration responsibility. Otherwise, if the total annual volume of any individual substance to intentionally be released from the article reaches 1 MT or greater, then the importer would have to register that substance.

I incorporate your product into a fluid that is sold to an automobile manufacturer. He fills components such as transmissions and engines with this fluid, and these components are then assembled into automobiles that are exported to the EU. Does the automobile importer have to register the substances in the fluid?
Lubricants, sold to transportation and construction equipment manufacturers, are used to fill components such as engines, transmissions, axles, and then the equipment or components are exported to the EU. ECHA (European Chemicals Agency) has posted at their website the following guidance regarding the REACH registration obligations of EU importers of these articles and the substances (lubricants) contained within the articles.

“5.2 Deciding whether a substance release is intended or not
If a substance is intended to be released from an article, it may have to be registered under REACH. It is therefore essential to establish whether the release of this substance from articles is intended or not, in order to identify the possible obligation to register this substance in articles.

As explained in section 5.1, if the main function of an object is to deliver a substance or mixture, then the object is to be seen as an article with a substance/mixture enclosed in it. This delivery of a substance/mixture is not to be regarded as an “intended release” from articles under REACH.

Thus, a substance is intended to be released from articles if it fulfills an accessory function which would not be achieved if the substance were not released (fragrance substances in children’s toys were given as an example of this in section 2.2). Consequently, substances that are released because of ageing of articles, because of wear and tear or as an unavoidable side‐effect of the functioning of the article, are generally not intended releases, 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 or functionality of the article, does not occur under normal or reasonably foreseeable conditions of use and is therefore not considered to be an intended release.

LEGAL NOTICE
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.

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