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The Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals, also known as REACH came into force on 1st June 2007.

REACH was put into play to improve the previous EU legislative framework for chemicals and also to improve the protection of human health and the environment.

In essence, any chemical which you import to any country in the EU needs to comply with the REACH regulation.

The chemicals could be for example liquid or gas form, and may be active or not active.

This regulation doesn’t only apply to huge industrial processes but also to the chemicals which are used in our daily lives.

Like cleaning products or paints or in items such as clothing or furniture.

There is a lot of information which pertains to the REACH regulation.

But for the scope of this course we'll touch on the basics which you might need to know.

So, what is the significance of this regulation? How does it apply?

Well, to comply with this regulation, companies need to check and manage the risks involved with their products that contain or use chemicals.

They then need to DEMONSTRATE to the European Chemicals Agency, also known as ECHA, that they understand the risks. They will also be required to prove how the product can be safely used while also communicating the risk management measures to the downstream users.

Chemicals which are already regulated by other legislations, like medicines or radioactive substances, may be partially or completely exempted from the REACH requirements.

Now, let's look at the various processes under REACH.

The registration process applies to chemicals which are imported at amounts greater than 1 tonne a year (that is from the 1st January to the 31st December).

You’ll need to aggregate the volume of your substance as a substance on its own, in a mixture, and in a product intended to be released.

These substances will need to be registered, if it was not already registered by a different entity.

There may be cases where some of the ingredients of your substance might still be under review.

Like for example with our client MyAirShield, one of the active components in their product was still under review when we were trying to register the product.

We therefore had to register the product in each member state individually.

In order to register, you’ll be required to prepare a registration dossier. This is composed of a technical dossier and, where applicable, a chemical safety report if you manufacture or import more than 10 tonnes of a substance per year.

How much would this cost?

REACH calculates the price based on two main factors:
How many tonnes are sold in the EU per calendar year, and
The turnover of the company that is registering the substance.

The more tonnage and the larger the income of the company trying to register the substance, the more costly registration will be.

Next let's look at the EVALUATION process.

This process covers two areas:
Dossier evaluation and
Substance evaluation

The dossier evaluation is where ECHA checks that the registration dossiers contain information of chemicals required by the legislation applicable to your product.

The SUBSTANCE evaluation involves member states which evaluate the substances AFTER they have identified specific concerns.

So the evaluation phase involves an assessment phase where your testing proposals are examined, IF you are looking to do tests.


The whole point of this evaluation phase is to avoid unnecessary animal testing, especially when involving vertebrate animals.

You’ll need to wait for ECHA’s decision before you can perform any testing.


Now, let's look at the AUTHORISATION process.

Okay, so this process is to ensure that the risks related to substances of very high concern (also called SVHCs) are correctly controlled throughout their life cycle.

A substance can be classified as an SVHC if one or various hazardous properties are identified in it.

These hazardous components are:
Substances that meet the criteria for classification as carcinogenic, mutagenic or toxic for reproduction also called CMRs
Substances which are persistent, bioaccumulative and toxic (or PBT) or VERY persistent and VERY bioaccumulative (vPvB) according to REACH Annex 13
And 3 , substances on a case-by-case basis that cause an equivalent level of concern as a CMR or PBT/vPvB substance



If a substance is identified as an SVHC, it is included in what is called the Candidate list.
There are some immediate obligations for suppliers whose substances are on this list.

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