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FAQs

Do I have obligations under REACH?

Under REACH, each substance manufactured or imported into the EU in volumes of greater than 1 tonne per annum needs to be registered, unless otherwise exempt. This applies to substances within mixtures and articles as well.

Our products are not hazardous, will they still need to be registered?

Obligations under REACH apply regardless of whether a substance has been classified as hazardous or non-hazardous.

What are phase in/non-phase-in substances?

Phase-in substances is the name for substances which were already manufactured or placed on the market before REACH entered into force.

A substance is considered to be a phase-in substance if it fulfils at least one of the following criteria:

-      It is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS)

-          It has been manufactured in the EU (including the countries that joined on 1 January 2007) but has not been placed on the market after 1 June 1992

-     It was placed on the market in the Community between 18 September 1981 and 31 October 1993 (including the countries that joined the European Union on 1 January 2007) before REACH entered into force and was notified under NONS (Directive 67/548/EEC) but it does not meet the definition of a polymer as set out in the Regulation

If it does not qualify as a phase-in substance, then it is a non-phase-in substance.

What is late pre-registration?

Late pre-registration is so-called because originally, the designated pre-registration period was between 1 June and 1 December 2008 to allow potential registrants to form a SIEF and submit a registration dossier jointly.

Pre-registration is still possible, but now termed late pre-registration, for those who are manufacturing or importing a phase-in substance for the first time since 1 December 2008. Late pre-registration is only possible if it is less than 6 months since the substance has been manufactured or imported into the EU in volumes > 1 tonne per annum and no later than twelve months before the relevant registration deadline.

The late pre-registration period has ended for substances manufactured/imported in volumes ≥ 100 tonnes per annum and for substances to be registered by 31 May 2018 (1-100 tonnes), the late pre-registration period ends on 31 May 2017.

So do I need to register immediately?

You have to register immediately in the following situations:

-          If your substance is a non-phase-in substance

-        If your substance is a phase-in substance manufactured/imported in volumes ≥ 100 tonnes per annum

-     If your substance is a  phase-in substance manufactured/imported <100 tonnes per annum but it has been more than 6 months since the date of first manufacture/import OR the substance is carcinogenic, mutagenic or toxic to reproduction

Which tonnage band/registration deadline is appropriate for my product?

The tonnage band/registration deadline should be based on the highest average tonnage on the basis of three year rolling averages for phase-in substances.

Where three consecutive years of import/manufacture data are available, the highest tonnage per year should determine when to register.

1-100 tonnes: Registration by 2018

>100 tonnes: Registration deadline has passed!

For non phase-in substances, the tonnage band should be decided based on the anticipated tonnage to be manufactured or imported - the substance needs to be registered immediately irrespective of the tonnage band but the tonnage band affects the level of information required as part of the registration dossier.

What is the general process of registration?

If late pre-registration is not applicable and immediate registration is required, the procedure to follow is to first submit an inquiry dossier in accordance with Article 26 of REACH, to ECHA. In order to do this you will be required to provide certain spectral and analytical data to prove substance identity (e.g. mass spec, UV-vis or XRD/XRF if appropriate). Once a response has been received from the European Chemicals Agency (ECHA), a registration dossier may then be submitted.

If late pre-registration is applicable then only the late pre-registration must be submitted immediately.

In all cases you would ultimately be required to submit a registration dossier and as such would incur costs either associated with acquiring a letter of access (LoA) to the dataset used for the registration by all registrants; this fee will vary according to tonnage band and substance identity or, if there is no existing dossier or dossier being prepared by a lead registrant, costs associated with substance testing in accordance with information requirements set out in REACH. In addition ECHA will charge a fee for registration; this fee is determined by your company size and the tonnage band to be registered.

What is a SIEF?

As one of the principles of REACH is to reduce unnecessary testing, potential registrants of the same substance are legally obliged to join a substance information exchange forum (SIEF). Members of a SIEF have to share existing studies, react to requests for information and work together to identify and carry out additional studies or submit testing proposals when needed.

Do I have obligations if I am based outside of the EU? Do I need an Only Representative?

Non-EU manufacturers or formulators do not have any direct obligations under REACH, however any of their EU importers who import a substance in volumes of greater than 1 tonne per annum would then be obligated to register the substance. It is therefore common for non-EU companies to choose to ensure the substance is registered to remove this obligation from their customers.

Non-EU manufacturers cannot register substances under the REACH Regulation but can appoint an Only Representative (OR) who is legally responsible for ensuring the substances are REACH compliant.

Non-EU distributors are not able to appoint an Only Representative. If you are a non-EU distributor and a non-EU manufacturer has appointed an Only Representative for a chemical substance which they supply to you, it may be possible for the tonnage of substance you supply to EU customers to be covered by an Only Representative agreement between the non-EU manufacturer and the Only Representative. However, you would need to negotiate this with all non-EU manufacturers from whom you purchase the particular chemical substance.

What documents do you need for our products to be registered?

The process of REACH registration is not just a matter of documentation, but will be likely to involve arranging testing on your substances, at the very least to confirm their identity.

How much does REACH registration cost?

This depends on various factors such as the company size, the tonnage band, the level of testing required or the cost of a Letter of Access.

The cost of REACH registration is therefore difficult to estimate without company- and substance-specific information but the cost can be broken down into the following areas:

-          ECHA Registration fee which depends on the company size, the tonnage band and whether it is a lead or a joint registration.

-          Cost of a Letter of Access and/or costs of any necessary substance testing in accordance with the information requirements set out in REACH

-          External or internal costs relating to the preparation of the registration dossier

Do the substances or mixtures contained within my product need to comply with CLP?

All substances and mixtures must be classified, labelled and packaged in accordance with the CLP regulation, irrespective of their quantities.

It may also be the case that some of your products fall under the definition of an article. An article is defined an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.

CLP only applies to substances within articles if the article is explosive (as described in section 2.1 of Annex I to CLP) or if the article is subject to REACH registration according to Article 7 or 9 of REACH (only applicable to substances present in articles in quantities of greater than 1 tonne per annum and which are intended to be released under normal or reasonably foreseeable conditions of use). So if the article is not explosive, or the substances within the article are not present in quantities > 1tpa and not intended to be released, then the substances do not need to be classified according to CLP.

Do I have any other obligations under CLP?

Yes, in addition to ensuring your substances and mixtures are classified, labelled and packaged according to CLP you must also notify substances to the Classification and Labelling (C&L) inventory in cases where you place the substance on the market and you either:

-          Manufacture or import the substance and it is subject to registration under the REACH Regulation or

-          Manufacture or import the substance and it is classified as hazardous, irrespective of the quantity

-          Import a mixture which contains the substance that is classified as hazardous and is present above the relevant concentration limit which results in the classification of the mixture as hazardous

-          Import an article containing substances which are subject to registration under Article 7 of the REACH Regulation

In accordance with Article 41 of the CLP Regulation, all notifiers of the same substance are required to unify their classifications where possible so that an agreed entry can be included in the inventory.

What are my responsibilities as a downstream user (I am not a manufacturer or a direct importer of a product from outside of the EU)?

You are obligated to:

-          Provide information regarding your uses to your suppliers

-          Implement measures specified by your supplier to ensure the safe use of the substance

-          Inform your supplier if you have any new information on the hazards of the substance or the risk management advice is not appropriate

-          Take appropriate action if using a substance included in the Authorisation List (Annex XIV List) or List of Restrictions (Annex XVII List)

-          If you are a formulator, provide customers with appropriate information on hazards and conditions of safe use for their mixture and be aware of your obligations under CLP

-          If you are the producer of an article, take action on registration or notification if required according to Article 7 and to communicate information if required by Article 33

If all of your suppliers are located within the EU or have appointed an Only Representative and you do not product any new substances or articles, then you do not have any registration or notification obligations. However, if your supplier has not provided you with adequate details to confirm that they have met their obligations, it is recommended that you contact them to check.

I don’t agree with the cost of the Letter of Access (LoA) – what can I do?

The cost of an LoA can vary significantly between substances and tonnage bands because it can depend on the costs of the studies involved and the number of registrants sharing the data, among other factors.

ECHA requires all registrants to make every effort to ensure that their data and costs are shared in a fair, transparent and non-discriminatory way. ECHA does not take part in discussions between potential registrants or regulate or assess the cost of shared data.

However, as a last resort, a data-sharing dispute can be submitted to ECHA. ECHA will make a decision based on an assessment of the potential registrants’ respective efforts to reach an agreement for which documentary evidence must be provided.

Do I need to supply a Safety Data Sheet (SDS) or an extended Safety Data Sheet (eSDS)?

In accordance with Article 31 of REACH, a supplier must provide an SDS in the following cases:

-          The substance or mixture is classified as hazardous according to CLP

-          The substance is defined as persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB)

-          The substance is included in the candidate list of substances of very high concern (SVHC)

-          The mixture is not classified as hazardous but fulfils the criteria in REACH Article 31 (3)

An eSDS summarises the key information from the chemical safety assessment (CSA) carried out under REACH – this information is provided as an annex to the SDS.

An eSDS therefore needs to be supplied in cases where a CSA is required i.e. when the substance is manufactured or imported into the EU in 10 tonnes or more per year.

A substance I supply or use is on the Candidate List or Authorisation List – what should I do?

ECHA regularly assesses substances from the Candidate List to decide which ones should be included in the Authorisation (Annex XIV) List. When ECHA has assessed a substance it may recommend it to be included in the Authorisation List and will publish the anticipated inclusion dates, latest application date and sunset date. If your substance is on the Candidate List you should check the ECHA website regularly for any updates.

If your substance is included on the authorisation list, you can either:

-          Plan to phase-out your use of the substance by the given sunset date and consider whether it can be substituted by a less hazardous alternative substance

-          If there is no suitable alternative, you can apply for authorisation (if you are an EU manufacturer, importer, distributor or appointed Only Representative) by the given latest application date

I supply a product which contains a biocidal active substance or a biocidal active substance on its own – what are my obligations?

All biocidal products require an authorisation before they can be placed on the market and the active substances contained in that biocidal product must be previously approved.

As of 1 September 2015, a biocidal product consisting of, containing or generating a biocidal active substance cannot be placed in the EU market if the substance supplier or product supplier is not included in the Article 95 list for the product type(s) to which the product belongs.

An application for authorisation cannot be made until the decision for approval of the last active substance in the product has been made.  This will appear on the Union list of approved substances and the date of approval is approximately 18 months – 2 years from the time the decision is taken.

I obtain a biocidal active substance from a supplier – do I need to do anything in regards to my obligations under the Biocidal Product Regulations (BPR)?

 

The Health and Safety Executive (HSE), the UK Member State Competent Authority, advises that all companies making biocidal products available on the market must be able to demonstrate, with a clear, auditable trail, that their active substance supplier is included in the Article 95 list – including both proof of the source of the active substance and a link to the source’s entry on the Article 95 list.

If you have any questions not covered by our FAQs, pleast contact us.

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