Frequently Asked Questions

General

Does Lubrizol understand the REACH legislation and have adequate plans and resources to ensure timely compliance?
Yes. Lubrizol has been actively preparing for the implementation of REACH for about 3 years. We developed a comprehensive inventory of eligible substances included in the products we produce in Europe or import into Europe and are finalizing the pre-registration of these substances before the November 30, 2008 deadline.  Lubrizol has a strong REACH Management Team and we are developing the systems 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 to benefit our supply chain.

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 pre-registration and subsequently 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.

Can I be assured that there will be no interruption in supply after November 30, 2008 due to REACH requirements?
We have a process in place to ensure that all the eligible substances will be pre-registered before the deadline.

Can Lubrizol provide the pre-registration numbers and certificates for the products supplied to us?
Most of the products that we supply are complex preparations which may contain several substances that must be pre-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 EU will be pre-registered by 30 November 2008.

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 will be registered as early as 01 Dec 2010, others 01 June 2013 and the latest deadline for lower volume substances on 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 the Lubrizol Additives products contain any substances likely to be Substances of Very High Concern (SVHC)?
To the best of our knowledge, none of the 15 Substances of Very High Concern (SVHC) listed on ECHA Member State Committee’s ‘candidate list’ for potential authorization are contained in our products.

Which substances are currently considered SVHCs?
On Oct 9th 2008 the ECHA’s Member State Committee (MSC) agreed on the identification of 14 Substances of Very High Concern (SVHC) that may become subject to authorization (1 additional substance was already identified without MSC involvement making the total 15).  SVHCs include carcinogens, mutagens, reproductive toxins, persistent bio-accumulative toxins (PBTs), very persistent, very bio-accumulative substances (vPvBs) and ‘substances of equivalent concern’ (e.g. potential endocrine disruptors).

What is authorization?
Periodically the EU Competent Authorities (CA) will nominate substances to a Candidate List where 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 Annex XIV and an application for authorization will need to be submitted by industry.  All unauthorized uses of these substances will be banned under REACH.

I’ve heard about pre-registration. What is this and what do I need to do?
Pre-registration is the first key phase of REACH and will take place between 1st June and 1st December 2008. Providing substances meet 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.  This pre-registration allows each EU importer or EU manufacturer to identify and track the substances they currently manufacture and/or import. The advantage of doing this is that it allows them 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. 

Are any substances in my product exempt from registration?
Registration begins at 1 MT per annum per legal entity so if your company manufactures or imports less than 1 MT of an individual substance, then (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. The polymer manufacturer or importer does not necessarily have to be the registrant of each monomer providing someone in the direct supply chain holds a valid (pre)registration. 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 your product that do not meet these criteria they do need to be (pre)registered.

What are some of the activities associated with the ongoing legal obligations related to substances which are pre-registered?
As a REACH pre-registrant, your company will need to track the annual volume of that substance by the legal entity for all EU manufacture, EU direct import or where you have agreed to serve as the ‘Only Representative’ for a third party exporter to an EU importer(s).  Based on the tonnage band your substance falls, that will determine the data requirements and the registration fee paid to ECHA.  Further, as a pre-registrant of a substance under REACH, your company will be invited to participate in a SIEF (Substance Information Exchange Forum) with other companies pre-registering the same substance.  Guidance on how SIEFs should operate is described in articles within the REACH regulation.  The aim is to avoid duplication of studies and to agree on the classification and labelling of the substance.  SIEFs will 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.

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 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.uic.fr/en_quoi_consiste_REACH.asp

What are the contact details of Lubrizol’s REACH co-ordinator?
Many people at Lubrizol are involved in the REACH activities. Mick Wragg, Manager - Product Stewardship, Europe is our REACH co-ordinator. However, we ask you to contact your Sales Representative for any question concerning REACH.

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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 pre-registered?
A downstream user can use and place on the market, without limitation in time, any batches of the substance that were supplied before the (pre)registration obligation of REACH started to apply, i.e. before 1 June 2008, as these batches were not subject to the (pre)registration obligation.  Any batches that were manufactured, imported or supplied to downstream
users after the start of the pre-registration period may be subject to enforcement. 
See page 41 of (http://echa.europa.eu/doc/reach/080611_REACH_ECHA_FAQ_2%202_Release_2.pdf).

Will Lubrizol include my downstream uses of its products in the registration?
Use/exposure scenarios will be communicated downstream at a later stage and there will be an opportunity for our customers to comment on the use/exposure scenarios that Lubrizol plans to support during registration.

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.  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 for more details. 

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Non-EU Customers

Do I have to register my product because of REACH?
REACH concerns individual substances. Most products imported into EU will be mixtures of substances (even a simple dilution is a mixture). There is no obligation to register the mixture under REACH but each individual substance in the mixture has to be registered by the importer or his/her Only Representative, unless the substance is exempt from registration.

I only sell my product to customers outside the EU. Do I have to do anything?
No. Only products imported into EU will be affected by REACH. Products produced and sold outside of EU are unaffected. The only exception is if you are using substances or mixtures exported from EU to make your product. You will need to work with your 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. What do I have to do? Am I the importer?
Any finished oil (usually a preparation/mixture) produced outside EU and intended for 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 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, including any diluent oil, and then registering each substance. Registration could be in collaboration with other companies 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 not least tracking the annual import or manufacturing volume.

I’m importing a polymer. Does that have to be registered?
No, polymers are exempt from registration (‘R’ of REACH). 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 importer does not necessarily have to be the registrant of each monomer providing someone in the importer’s supply chain holds a valid (pre) registration. 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 by someone in your supply chain. This requirement has introduced significant complexity in determining and tracking the compliance status of imported polymers and customers wanting to import products containing polymers into the EU should seek expert advice, or work with a knowledgeable industry partner like Lubrizol.

My EU representative only imports a small amount of my product each year. Does he/she still have to register all the substances?
Registration begins at 1 MT per annum per legal entity (i.e. your importer) so if the annual product volume imported by your representative translates into less than 1 MT for some or all of the individual substances in your product, then these do not require registering. Note that the same substance might have been registered by another company (importer) if they are importing 1 MT or greater. This does not affect your responsibilities 

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?
Non-EU customers who source and blend their finished fluid 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 included their intended application (e.g. an automotive lubricant). These are known as identified uses and it is expected that these will be listed on the supplier’s safety data sheet. If your intended use is not listed you may have an obligation as a downstream user.   

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. Only importers and manufacturers (or their Only Representatives) who submit a pre-registration themselves will be able to take advantage of this ‘phase-in’ transition period. 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. In this case, the importer has to either (a) withdraw their product from the market in the EU and submit the full registration before importing again or, more likely, (b) submit his/her own pre-registration to the new European Chemicals Agency within a certain period of time following first import. The list of all substances that have been pre-registered is expected to be published late 2008/early 2009 but this will not contain the names of the companies who submitted the pre-registration.  

I want to send a sample of my product to Europe for a customer 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 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.

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, your responsibilities will then depend on the volume of each substance imported. If the total annual volume of any individual substance reaches 1 MT or greater then the importer would have to register that substance unless the substance is not intended to be released under normal or reasonably foreseeable conditions of use.

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 EU. Does the automobile importer have to register the substances in the fluid?
In the absence of a definitive judgment from the European Court of Justice (ECJ) and/or European Chemicals Agency (ECHA) on this situation, the automobile manufacturers’ REACH task force has addressed this situation in their guidance document on REACH (Version 1.0, 11th July 2007). They conclude that only substances intended to be released as part of their normal functionality (such as windshield washer fluid, fragrances, fire-extinguisher fluid/powder and compressed gases for pyrotechnic devices) are within scope of registration (and pre-registration) under REACH Article 7.1. They also conclude that release of substances from components as part of normal wear and tear is not within scope. Although this guidance may contradict examples published as part of the (non legally-binding) RIP 3.8 Guidance for industry concerning substances in articles, Lubrizol’s position is aligned with that of the Automobile Manufacturers’ REACH task force until ECJ judgment forces us to act otherwise.

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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.