This article features questions asked during our “REACH 2018 and Beyond” webinar, which you can listen to here.

Does the most current version of REACH still contain obligations for the "downstream user"?  Is there still a downstream user concept in REACH? 

Indeed, downstream users still have obligations under REACH. The main obligation is the communication in the supply chain. This communication will vary depending on what ‘kind of use’ you are making of the substance but also on the substance itself (for example substances subject to authorization). The obligations will most likely cover both upstream and downstream communication (such as communicating the safe use down the supply chain or checking that your uses are covered by the supplier’s exposure scenarios).

ECHA details this in a specific Guidance document for downstream users.

 

Will there ever be a global REACH?

I think this is an interesting question. We can see that REACH-like legislation is spreading all over the world – for example to Turkey but also in Asia.

On the other hand, the US has deliberately taken a different approach with TSCA. And this will probably also stand as a model for other countries.

There are international initiatives, such as the Strategic Approach to International Chemicals Management where we can try to agree on a common approach. But if we look at the example of the Globally Harmonized System (GHS) for classification and labeling - we see that it was a very good idea to agree on how to classify and label substances. But in practice companies are still faced with many different variations to these rules. So, the answer is “No” but I am convinced companies will be facing more and more chemical legislation globally. 

 

To which U.S. manufacturers does REACH apply?

The short answer is potentially any US manufacturer, as soon as they want to export their products to the EU market.

But strictly legally speaking – the REACH regulation cannot impose any obligations on the US manufacturer. Instead, the REACH rules target the EU importers.

But of course - it will be in the highest interest of a US manufacturer to make sure that their products destined for the EU market are REACH compliant.

But of course - it will be in the highest interest of a US manufacturer to make sure that their products destined for the EU market are REACH compliant.

In fact, many companies exporting to the EU decide to handle their REACH obligations themselves, with the help of a so called Only Representative who is based in the EU, instead of the EU importers. This option can be driven by several reasons; for example, keeping control on their access to EU market, or ease sales, by releasing the burden from their EU customers.

Even companies whose customers are not based in the EU may need to make sure their products meet the EU REACH requirements.  Let’s say you are a US-based company supplying a component to a US-based machine manufacturer. This manufacturer places this component in a machine that he then sells in the EU. In order for your customer, the US machine manufacturer, to make sure that his machine can safely be placed on the EU market, he should ask you to guarantee that your component is okay by the EU REACH (is compliant with REACH chemical restrictions, for example).   

Further all substances and mixtures that meet the criteria for classification as hazardous under CLP must be supplied with an SDS.

 

Could you comment on the impact of Brexit on REACH?

On 30 March 2019 – UK is expected to become a non-EU country -and it has still not been decided yet - what is going to happen to the chemicals regulations in the UK.

ECHA has published information regarding the rules after Brexit – if nothing else is agreed between the parties. For example:

All UK registrations will be regarded as “non-existent” and authorizations will cease to have an effect

Only representatives in the UK can no longer be used, so if you are an American or Chinese manufacturer and you used an OR in the UK you should make sure that they will open an office in EU 27 before Brexit happens and transfer the registration to that legal entity.

Further – the downstream users in the EU -that use UK manufacturers - will become importers and need to register

UK lead registrants will need to transfer the role to other registrant or transfer the role to their own legal entity in EU 27.

All these things are quite mind blowing if we consider that UK is the second largest country in terms of registrations after Germany.

So, no wonder the chemicals Industry in the UK wants to keep ’Status Quo’.

The UK’s Chemical Business Association has said that the most pragmatic and cost-effective way forward would be to keep REACH as it is and use the same institutions as today.

 

How will the circular economy discussion impact the future of REACH?

Currently there are no proposals to amend the REACH regulation to take into account the circular economy.

 

We are manufacturer of small miniaturized electric motors. Are REACH declarations applicable to us?

The registration requirements of the REACH Regulation apply to:

- any substance or mixture you import into the EU in a volume greater than one ton per year;

- any substance contained in an article you produce or import into the EU if a) the substance is present in those articles in a quantity exceeding one ton per year and b) that substance is released from the article (under its normal and foreseeable conditions of use).

The requirement to notify ECHA the presence of SVHC in the miniaturized electric motors applies if that SVHC is present therein in a concentration above 0.1% (w/w) of the motor and the total amount of that SVHC in all motors you produced and/or imported (and which contain this SVHC in a concentration greater than 0.1% (w/w)) is greater than one ton per year.

The notification requirement does not apply if a) there no human or animal exposure to the SVHC during the article’s normal and foreseeable conditions of use (including the article’s disposal) or b) that SVHC has already been registered by another company for that use.

 

With regards to the new anti-poison center notification requirements, will the anti-poison information be public information?  

According to Article 45(2) of the CLP Regulation, the information provided to the Member States appointed bodies is confidential. It can only be used for medical purposes (such as in the event of a medical emergency) or for statistical purposes.

 

As per your webinar, it is a mandatory obligation to communicate SVHC information to users. However, in practice many of our adhesive and consumable item suppliers from Europe charge us for issuing RoHS/REACH certificates. Our purchase terms in PO documents clearly states that we need RoHS and REACH compliant materials. Is there any official rule which states that the delivery of REACH declarations should be free of charge?

According to Article 33(1) of the REACH Regulation, the supplier of an article containing a SVHC must provide its recipient with sufficient information to allow for its safe use free of charge. This information must be provided upon the first supply of the article.