Lorax Compliance Ltd

Free Webinar: Tuesday 8th August
10am (EST) | 3pm (GMT) | 4pm (CET)


REACH webinar for beginners

Although the EU REACH legislation has been around for many years, the final registration deadline is now less than one year away.


If you are struggling to find a way through the depth of information, please join us as we present REACH for beginners, a practical overview which will break down the complexity and provide you with clear steps forward. Focussing on the final registration deadline (May 31 2018), our Environmental Compliance Manager, Emma Mundy, will outline what companies need to do to ensure successful registration and remain compliant.

We will cover the topics of:

  • Background on REACH regulation
  • Who is obligated
  • 2018 registration deadline
  • 7 Steps to registration
  • Impact of Brexit on REACH

To request the recording, please follow the registration process using the form on the right.

After registering, you will receive a confirmation email containing information about receiving the webinar recording.


FAQs

When is the 2018 deadline?
If you have pre-registered substances that you manufacture or import from outside the EU above one tonne but not more than 100 tonnes per year and have not already registered them, the REACH registration deadline is 31 May 2018. This is the last registration deadline for existing chemicals, the two previous deadlines were in 2010 and 2013. 

What if I am already placing a substance on the market but it doesn’t get registered by the deadline? 
No data, no market access. If you do not register your substance in time then you cannot manufacture or import it in volumes of 1 tonne or more per year. If you miss the deadline, you will need to register your substance before you will be allowed to re start the manufacturing process or import. If you continue to sell products then you will be in breach of the REACH regulations and you could be fined. REACH enforcement is operated on a country level so it is best to refer to the enforcement legislation in place in each country you are selling into. 

Do companies need to understand REACH legislation to register?
Yes, you will need a fundamental understanding so that you are aware of the ways in which REACH affects your company. You will need to know what technical information you need for registration on the chemical and its hazards. You can get help from experts to guide you and the ECHA website has lots of guidance documents and webinars telling you how to comply with REACH. There is a lot of information out there that is readily available.  

What is pre-registration? 
Pre-registration is only for companies planning to register phase-in substances. Companies who imported their substance for the first time after 1st December 2008 could, in some cases, complete a late pre-registration. The final remaining deadline for late pre-registration was 31st May 2017 for substances in the 1-100 tonnes per annum band with the registration deadline of 31 May 2018. 

What is a phase in substance? 
A phase in substance is in simple terms an existing substance. 

REACH defines phase-in substances as those that: 

  • Are listed in the European Inventory of Existing Commercial Chemical Substances (EINECS), or 
  • Were manufactured in EU countries in the past but have not been placed on the EU market since 1 June 1992; or 
  • Substances that qualify as "no-longer polymer. 
If your substance is “new” (i.e. ‘non-phase-in’) or is a phase-in substance that has not been preregistered, you must submit an inquiry to ECHA and register it before you can manufacture or import the substance at 1 tonne or more per year.

How do I find out if another company has already registered a substance I want to register?
There is a list on the ECHA website where you can find out who intends to register or who has already registered a substance. You can check on the joint submission pages in REACH-IT. 

If your substance has already been registered then you need to find and contact the lead registrant as soon as possible. You will need to buy a letter of access from them to ensure that you are part of the joint submission. If you have pre-registered then you will have probably heard from the lead registrant. If not then you should check the pre-SIEF pages of REACH-IT and ECHA’s database of registered substances as a starting point. 

What information do I need to provide if my substance has already been registered?
If the information has already been supplied by the lead registrant then you do not need to include that information in your submission. However, even if a lot of the work has already been done you will still have work of your own to do. Your dossier will need to include company specific information so be prepared for the time and resource to accommodate this. 

What if I don’t know the chemical composition of the mixture I import?
It is your duty to have information on the composition of the mixtures imported. As an importer you will need to know, at the very least, the identity and percentage content of all substances in the mixtures that you import in amounts of more than 1 tonne per year. 

You may be in a situation where you cannot get the information from the non-EEA supplier as they may not be willing to give it. In this instance, there are a couple of things you can do: 

  • You can bypass the supplier and go straight to the formulator and ask them for the information you need.
  • You can ask the non-EEA formulator to appoint an only representative to take on the compliance obligations. 
  • You can establish the composition of the mixture through your own analysis. 
  • You can find an alternative supplier. 
How do you decide who should be the lead registrant when registering a substance that isn't already registered?
SIEF members have to formally agree on the lead registrant – even if only one volunteers. If more than one member comes forward and between them they can’t decide who should go forward as lead registrant then the other members of the SIEF need to elect a lead registrant. If nobody comes forward then ECHA propose that by default the manufacturer or importer who produces or imports the highest volume of substance should be the lead registrant. Please note that it is important to elect a lead registrant as early as possible. 

Is any additional registration required if manufacturing/importing more than 10 tonnes a year and need to record a chemical safety report?
If you manufacture or import in quantities of 10 tonnes or more a year then you will need to carry out a chemical safety assessment. This will enable you to assess the intrinsic properties, manufacture, use, exposure and risk of the substance. You will also need to think about hazard criteria, and the chemical safety assessment needs to include an assessment of the exposure if the substance fulfils certain hazard criteria. You need this to show that the risk can be controlled with a set of operational conditions and risk management measures. This information needs to be documented in a chemical safety report by the registrant and it can be submitted by companies separately or as part of the joint part of the registration dossier. 

How much will it cost me to register?
The cost of registration varies depending on several things such as the type of substance, the cost of the studies needed, the tonnage band you fall into, the size of your company and the number of registrants involved in registering the substance. Therefore, it’s hard to know the exact costs before you start out but you can start budgeting for these. 

You can find the ECHA fees for registration on their website and through applicable legislation here. The level of fee will depend on the type of dossier, the tonnage band of the substance etc. However, ECHA fees are just a small proportion as it is the information gathering costs and the cost of resource for the registration that needs to be considered. 

It's important to note that companies only need to pay for the data needed in their own registration and a fair contribution for the preparation of the joint dossier. 

What do I do once I’ve registered?
You will need to make sure that your registration dossier is kept up to date. You should put a process in place to review and maintain the registration dossier. If any new data emerges you would need to update the dossier with this new information. 

I use chemicals, how does the registration affect me? 
You will need to make sure that the chemicals you are using are being registered for your use by your suppliers. If they are not registered you will risk not being able to use them after the 2018 deadline which could have a serious effect on your business. 

If I have a mixture. Is the tonnage requirement applicable to the mixture or the REACH chemical?
The requirements apply to each individual substance contained in the mixture. You will need to identify the individual substances contained within the mixtures. You can use ECHA’s navigator tool to identify the substances contained within your mixtures. 

If you are producing or importing a mixture, you need to register each individual substance in your mixture if you produce or import it at one tonne or more per year.

If you are a formulator who mixes the individual substances to produce the mixture, you do not need to register each substance under REACH unless you are also a manufacturer or importer of the individual substances contained in the mixture.

If the intended use is not available then is there an option to register in for eg "other" category?
Intended uses should be covered by the registrant. If your use is not covered in the registration then this should be made known to the person responsible for registering the substance. Communication up and down the supply chain is imperative to ensure that intended uses are covered. If you are a downstream user and not responsible for registration then you should make sure that you establish contact up the supply chain regarding the uses of the substances and ensure this information reaches the registrants of the substances. 

When CSA obligations apply, the registrant is expected to cover all the identified uses in his registration dossier and generate the related exposure scenarios. Uses for which safe use has not been demonstrated by the registrant in exposure scenarios should be identified as ‘uses advised against’ or be addressed by the Downstream user by a DU Chemical Safety report including the corresponding notification to ECHA.

Firstly, you will need to check if your use and foreseeable uses of your products are included in the identified uses covered by the exposure scenarios included with the safety data sheet. You will then need to check if your activities are covered. You will need to check the conditions of use and compare operational conditions and risk management measures. 

Downstream users can make uses known to their suppliers before the manufacturer or importer submits their registration so that these uses can become identified uses. This makes the handling of exposure scenarios easier for the registrants. REACH regulation gives the right to any downstream user to inform his supplier (Manufacturer or importer) about the use(s) of a substance on its own, or in a mixture, with the aim of making this an identified use. 

An overview of how to decide whether or not your use is covered by the exposure scenario can be found in the Guidance for downstream users produced by ECHA.

While you stated that companies established outside the EU do not have (official) REACH obligations, if those companies export to the EU, would they not have implied support requirements to their EU customers to provide communications and/or notifications regarding compliance verdicts and identification of authorizations (or applications for authorizations) when applicable?  Therefore, such companies must also be knowledgeable of the REACH regulation to understand and to comply with those support requirements.
It is the importers responsibility check to see if a substance they use has been placed on the candidate list if they are importing from outside the EU or EEA. If it has been moved then it is up to the importer if they want to continue using that substance or inform the supplier of the move to the candidate list or if they will use an alternative substance. If the substance is moved to the authorisation list then the importer has to stop importing the substance by the sunset date otherwise they are not complying with the REACH regulations, this is the importers responsibility to communicate to the supplier if they are not in the EU or EEA. Only manufacturers, importers or downstream users of a substance on the Authorisation List can apply for authorisation. If authorisation is granted for a specific use or under specific conditions, etc. it is again the importers responsibility to communicate this to the supplier outside the EU if necessary.

However, if your products are obligated under REACH then it is wise to have an understanding of the regulations and how this may affect the product in the supply chain as this could be a deciding factor in using you as a supplier as to whether the product can be imported into the EU and if you are willing to offer much needed support to your customers. 

Is there an obligation after May 31, 2018 for distributors to report volumes back to manufacturers?
A distributor has an obligation to pass information up the supply chain so that manufacturers and importers understand how their substances are used and to register some or all of the uses you have made known to them. This can include any new information on hazardous properties of the substances or mixtures or information which may make inappropriate the risk management measures they have received in the safety data sheet (such as volume used). After registration, communication in the supply chain is one of the distributors responsibilities.

What are the action items for downstream users for the 2018 deadline?
Identify business-critical substances: Compile an inventory of the substances you buy and their uses. Then identify vulnerabilities in your business - products you buy, products you sell, services you offer, processes you perform, etc. If you buy proprietary mixtures you need to know what substances you are buying, this might include a number of business-critical substances. Start collating information on use: Your supply chain's registrant should want to know your uses for the registration dossier. They should also be aware of any processes or products your customers use the substance for to be included in the registration. There is a Use Descriptor system described in Chapter 12 of ECHA's guidance on the Chemical Safety Assessment for describing your uses. Five key parts of compliance of downstream users:

  1. Use information from the suppliers from the safety data sheet and extended safety data sheets to ensure your use of chemicals is both safe and in scope of the registration. You can ask your supplier to include your use in these if it isn't already included.
  2. Inform your supplier of any new hazard information, if risk management measures are not appropriate for your particular use, or if any other effects occur when using the recommended risk management measures.
  3. Ensure that you pass on all relevant hazard information, safe conditions of use and any risk management measures to your customers. If you formulate mixtures you do not need to prepare an exposure scenario for your mixture.
  4. Notify ECHA if you use a Candidate List substance to produce an article if it has not been registered for that use where the substance is used in quantities over one tonne per producer per year and is present in the article above a concentration of 0.1%.
  5. Do not use a substance subject to authorisation after the 'sunset date' unless an exemption applies to you or an actor up your supply chain has an authorisation covering your use.
Product availability and pricing is likely to change significantly as a result of REACH so it's best to be aware of what's happening in your supply chain to minimise the likelihood of REACH compromising your business.

Is there clear guidance on what documents are to be maintained by distributors of products for which chemicals have been used, but who are not distributing chemicals themselves. 
A distributor has an obligation to pass information up the supply chain so that manufacturers and importers understand how their substances are used and to register some or all the uses that you have made known to them. This can include any new information on hazardous properties of the substances or mixtures or information which may mean that risk management measures they have received in the safety data sheet (such as volume used) are inappropriate. After registration, communication in the supply chain is one of the distributors responsibilities. 

For articles containing substances of very high concern, you have a duty to provide customers with sufficient information to allow the safe use of the article. If an article producer, for example, purchases substances inside the EEA for use in the production process of their articles, then they also must fulfil downstream user requirements. If the substances are instead purchased outside of the EEA, the article producer has the role of importer of substances along with the related obligations, such as registration.

For the products you deal with, you will need to pass health and safety information (including Safety Data Sheets) up and down the supply chain. Importantly, your customers may need you to ask questions or pass information up the supply chain and it is important that you help. For example: 

  • If your supplier provides information on the hazards or safe handling of a product, then you would have a duty to provide this to your customers; 
  • If your customers provide information about their uses of products, you should pass this on to your supplier. Customers may need to make the company who will register the substances aware of their use for it to be supported in the registration. 
  • Customers may want to know that the substances they are using have been preregistered/registered under REACH. 
As some supply chains have many links, each distributor must pass the relevant information up and down the supply chain for REACH to operate properly.

You should not distribute products containing substances that should have been either pre-registered or registered, but haven't. Substances supplied legitimately to a distributor before a registration deadline can continue to be distributed, but you will need to retain evidence of the date of supply to demonstrate that this continued supply is legal. 

You need to keep all information that you require to carry out your duties under REACH for a period of at least 10 years after you last supplied a substance/preparation. 

Guidance documents can be found on the ECHA website here

What will be the registration procedure for new substances after the May 2018 deadline?
REACH regulation has replaced the notification of new substances (NONS) which was the old framework in the EU and the registration deadline is for existing chemicals. If you are placing new substances onto the market then you would be required to submit an inquiry to ECHA.

Under REACH, new chemical registration would require an inquiry dossier submitted to ECHA. This applies to companies who would like to put a new substance on EU market for the first time and companies who decide to register an existing substance without pre-registration.

After an inquiry has been submitted, ECHA then will indicate what data is available for sharing, and which information requirements would require new studies involving vertebrate animals. ECHA will also inform potential registrants of the contact details of previous registrants and other potential registrants.

Until when can a substance which is not registered stay on the market? 
Article 5 of the REACH regulations sets out the principle of no data, no market access. This applies to all substances that are manufactured or imported in quantities of 1 t/a or more if they have not been registered or pre-registered. 

This means that a company planning to start manufacture or import of 1 t/a or more of a phase-in substance after the relevant registration deadline given in Article 23 of REACH needs to have validly registered the substance before starting this activity.

Non-phase-in substances and phase-in substances which have not been pre-registered must be registered before manufacture or import can continue. In this case the registrant may have to wait for 3 weeks before continuing manufacture or import (Article 21 of the REACH Regulation). Prior to registration of these types of substances the manufacturer or importer needs to make an inquiry to ECHA regarding any previous registration for that substance.

After the submission of the registration dossier it may take up to three weeks before ECHA informs the registrant whether his registration is complete or not. Manufacture or import of a substance cannot start before the end of this period and can only start once ECHA has informed the registrant that the registration is complete and a registration number has been assigned.

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