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EU legislation: Chemicals REACH

REACH –abbreviation for Registration, Evaluation

and Authorisation of Chemicals- is the EU’s policy on

chemicals. Depending on the use of the chemical

substances the REACH legislation sets obligations,

differing from the obligation to register chemicals to

restrictions on the use of certain dangerous

substances. Although EU companies are technically responsible for meeting the

obligations under REACH (Regulation (EC) 1907/2006), suppliers outside the EU

will be required to provide information on the chemicals used in their products.

Answering the questions on page two of this document can help you to

determine if, and to what extent, REACH is relevant for you. Furthermore it

refers to more detailed information on the possible obligations.

Communication within the supply chain is a must!

As said before, your EU importer is responsible for meeting the requirements

under REACH. However, a direct consequence of your EU importer’s non-

compliance with REACH may be the discontinuation of your exports. It is likely

that your EU importer needs hazard data, safe use information and volumes on

the chemicals you use and will choose other suppliers if you cannot provide this

information. Therefore, an inventory of the substances, mixtures and articles

that contain dangerous substances or substances which will be foreseeably

released from the articles will be a very possible requirement from your EU

importer. Please note that in case you do not produce chemicals yourself but

you buy them, you have to get the specific data from your supplier to make the

data you need to provide to your EU importer complete (supply chain

management).

Considerations for action

You can wait until your EU importer requests data on the chemicals that you

use or are traceable in your product, but you can also anticipate the

possible requests by EU importers with the following actions:

1. Ask your buyer for their requirements regarding REACH.

2. Create an inventory of all chemicals used, including raw materials and

additional materials being used in your production processes and which

can also be found in the final product (i.e. substances, substances in

mixtures and/or substances that can be released by the final products).

This inventory should include:

Name of the substance;

Characteristics of the substance (hazard data, safe use information,

etc.);

Quantity exported to the EU per year;

Origin (where does it come from);

Final destination (to whom sold).

It might be necessary to gather information from your suppliers in order to

complete your inventory.

3. Check the website of the European Chemicals Agency to find out if the

substances or uses in your inventory are exempted from the registration

under REACH.

4. Stay in close contact with your buyer.

EU legislation: Chemicals REACH

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Answer these questions to determine if and how REACH is

relevant for you

Substances: Are you exporting (mixtures of) substances to the EU? Relevant for CBI sectors natural ingredients for cosmetics.

Yes --> Depending on the volume that your importer imports, the substance may be subject to registration. Again, this is the EU importer’s responsibility. Some substances, for example, food products and pharmaceuticals, are exempted from the obligation of registration. The possible obligations under REACH for some products may depend on the eventual use. For example, pigments that can be used in food and non-food products. They fall within the scope of REACH when used for non-food products, while they have to meet EU food legislation (and are exempted from obligations under REACH) when used in food. Click here for more information on registration in this document

Articles: Are you exporting articles to the EU? Relevant for the CBI sectors: Garments, home decoration & home textiles, automotive components, electronics pipes and process equipment and engineering products. Does your product release substances intentionally? For example scented textiles.

Yes--> Producers of articles can be subject to obligations under REACH in several ways. Check the other questions, to see in what way it may affect you. The intentionally released substance is seen as a substance as such, and therefore may be subject to registration.

Does your article contain ‘dangerous’ substances? REACH restricts the use of certain substances for example substances with carcinogenic characteristics. On the one hand there are requirements for so called Substances of Very High Concern (SVHC). Furthermore REACH sets restrictions for specific substances and specific uses in Annex XVII of the Regulation. This Annex XVII is a direct transposition of the existing restrictions on the marketing and use of certain chemicals before REACH entered into force.

Yes SVHC--> If your product contains SVHC from the so called candidate list, your importer must provide information on safe use to the final users. If the substance is moved from the candidate list to Annex XIV of the REACH regulation your EU importer must ask the authorities for authorisation to place the product on the market en eventually replace it by safer substances. For you this means that you will have to provide information on the SVHC you use and probably look for substitutes for them. Click here for more information on SVHC in this document Yes restricted substances --> The restrictions concern specific substances and/or specific uses e.g. limitations on certain colorants in textiles or certain softeners in toys and childcare articles. Your product must comply with these requirements. Click here for more information on restrictions in

this document

EU legislation: Chemicals REACH

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To whom can you turn with questions?

Your buyer

One very useful source of practical information can be your EU importer. He

knows what his obligations are and what he expects from his suppliers to make

it possible for him to meet these requirements.

Also check if he provides tools that make it easier to show compliance, e.g. lists

of chemicals that you should not use or software systems which you can use to

make an inventory of used chemicals.

Sector associations

You are not the only company in your sector that may face difficulties in

interpreting this relatively new and complex legislation. Several sector

associations have studied the consequences of REACH for their products.

European Chemicals Agency (ECHA)

ECHA is the EU’s authority on REACH. Its website provides information on the

Regulation, guidance on REACH provisions, IT tools for REACH uses and

Frequently Asked Questions.

Member States’ competent authorities

Each EU Member State has appointed a national REACH helpdesk. All national

helpdesks van be found here.

The EU Export Helpdesk

The EU Export helpdesk provides information on legal requirements, tariffs,

preferential arrangements, quotas and statistics. Under ‘my exports’ you can

search for the requirements applicable to your products (all requirements, so not

only regarding chemicals).

Registration

(Mixtures of) substances are subject to registration with

ECHA, if they are exported to the EU. The actual

requirements depend on the nature of the substance and if

the volume is ≥ 1 ton per importer per year. Substances

or mixtures in containers (e.g. printer cartridges) are

considered ‘substances’ and are therefore subject to

registration as well. Substances in articles which are intentionally released

during their use (e.g. a fragrance in a scented eraser), also have to be

registered. If substances fall under the obligation to register, but are not

registered they may not be placed on the EU market.

Exemptions

The obligation to register does not apply to substances used:

in medicinal products for human or veterinary use;

as a food additive in foodstuffs;

as a food flavouring in foodstuffs;

as an additive in feeding stuffs;

in animal nutrition;

substances included in Annex IV and Annex V of the Regulation.

How are you involved?

If you are exporting (mixtures of) substances (e.g. cosmetic ingredients) or

articles that intentionally release substances which are not exempted from the

obligation to register, it is most likely that your EU importers have already

(pre-)registered the substance. However, they might need information from

you on the substances you are using, to be able to meet their obligations.

For the CBI target group, it is not expected that exporters will have to register

substances themselves. However, to avoid the risk of discontinuation of your

exports, communication with your importer in this matter is essential.

EU legislation: Chemicals REACH

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temporarily excluded: polymers, however monomers do need to be

registered! (see guidance)

Pre-registration

Until December 2008, chemical producers and importers in the EU had the

opportunity to pre-register the chemicals used. Pre-registration provided

registering companies with more time to obtain and compile the information

necessary to complete the ‘normal’ registration. Substances that have not been

pre-registered need to be registered as a new substance, which is a more

complicated process. Click here for a list of pre-registered substances.

Only representative

If a substance is not registered by your EU importer, and you use substances

subject to registration, you can appoint an ‘only representative’ to register the

substance for you (you cannot register the substance yourself, since you are not

an EU based company). An only representative can represent one or several

non-EU companies.

Click here for EU guidance on registration.

SVHC – Substances of Very High Concern

In order to import or use substances with properties that are deemed to be of

very high concern (the so-called Substances of Very High Concern (SVHC)), for

example because they are carcinogenic, persistent in the environment or

bioaccumulative, EU companies must apply for an authorisation with ECHA

before they may be used or placed on the market. The identification of a

substance as Substance of Very High Concern and its inclusion in a Candidate

List of SVHC is the first step of the authorisation procedure. Following the

identification as SVHC, a substance may be included in the Authorisation list

(Annex XIV of the REACH Regulation) and become subject to authorisation. If a

SVHC is placed on the Authorisation list companies have to send an application

to ECHA requesting the authorisation for specified uses of these substances.

Substances of very high concern include substances which are:

Carcinogenic, Mutagenic or toxic to Reproduction (CMR) classified in

category 1 or 2;

Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very

Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH

Regulation; and/or

Identified, on a case-by-case basis, from scientific evidence as causing

probable serious effects to humans or the environment of an equivalent

level of concern as those above (e.g. endocrine disrupters).

At the time of publication the Candidate List of SVHC contained 155 substances.

Please note that substances are added to the Candidate List of SVHC frequently.

To maintain up-to-date with the latest list, it is advised to check ECHA’s website

on SVHC on a regular basis.

Companies may have immediate legal obligations following the inclusion of a

substance on the Candidate List which are linked to the listed substance on its

own, in preparations and articles:

EU suppliers of articles which contain substances on the Candidate List in a

concentration above 0.1% (w/w) have to provide sufficient information to

their clients or upon request to a consumer within 45 days of the receipt of

the request. This information must ensure safe use of the article and as

minimum contain the name of the substance.

EU legislation: Chemicals REACH

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And EU producers or importers of articles have to notify ECHA if their article

contains a substance on the Candidate List. This obligation applies if the

substance is present above 0.1% (w/w) and its quantities in the

produced/imported articles are above 1 tonne in total per year per

company.

To be able to meet these obligations, EU importers need to know if and which

SVHC are present in the articles they buy.

Substitute It Now (SIN)

Inclusion of a substances in the Candidate List of SVHC is a clear sign that that

particular substance should be considered unwanted and alternatives should be

used where possible. To speed up the substitution of dangerous substances by

safer alternatives, ChemSec (The International Chemical Secretariat) has

developed its own list of substances which should be considered SVHCs based

on the criteria established by the REACH Regulation (the SIN-list). The latest

version of this list contains 626 substances.

Although this list has no legal consequences, the industry may see it an

advanced warning for restrictions to come and even some EU Member States’

governments advise to use this list when developing criteria for public

procurement. Click here for ChemSec’s website on SIN.

Authorisation

SVHC will be gradually included in Annex XIV of the REACH Regulation. The aim

of authorisation is to ensure that risks from SVHCs are properly controlled and

that these substances are progressively replaced by suitable alternative

substances or technologies, where these are economically and technically

possible. There is no tonnage threshold for a substance to be subject to

authorisation.

Once included in Annex XIV, the substances cannot be placed on the market or

used after a to be set date (the so-called “sunset date”) unless authorisation is

granted to the EU company using the substance, or placing it on the market.

Substances listed for authorisation

At the time of publication, 22 substances subject to authorisation were included

in Annex XIV to REACH .

Substance Sunset date

musk xylene 21 August 2014

4,4`-diaminodiphenylmethane- MDA 21 August 2014

hexabromocyclododecane - HBCDD 21 August 2015

bis(2-ethylhexyl)phthalate - DEHP 21 February 2015

benzylbutylphthalate – BBP 21 February 2015

dibutylphthalate – DBP 21 February 2015

Diisobutyl phthalate (DIBP) 21 February 2015

Diarsenic trioxide 21 May 2015

Diarsenic pentaoxide 21 May 2015

Lead chromate 21 May 2015

Lead sulfochromate yellow (C.I. Pigment Yellow 34) 21 May 2015

Lead chromate molybdate sulphate red (C. I.

Pigment Red 104)

21 May 2015

Tris (2-chloroethyl) phosphate (TCEP) 21 August 2015

2,4-Dinitrotoluene (2,4-DNT) 21 August 2015

Trichloroethylene 21 April 2016

EU legislation: Chemicals REACH

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To get authorisation the EU company has to prove that the risks from the use of

the substances are either adequately controlled or justified on socio-economic

grounds. Furthermore it has to show that no alternatives are available.

Authorisation will only be granted on a case-by-case basis for a limited period

and will be reviewed after that period.

Please note that there is no obligation for authorisation for SVHC in articles

imported from outside the EU, although the obligation to notify the presence

of these substances still applies. Click here for EU guidance on authorisation.

How are you involved?

It is your EU importer’s responsibility to apply for authorisation and, if

necessary, provide notification of articles and their uses. Again he may need

information from you on the substances used.

A possibly more important conclusion that could be drawn from the inclusion of

a substance on the candidate list of SVHC is that it should be considered as a

sign that these substances are ‘unwanted’ by the EU. The use of these

substances may still be allowed (under conditions) for now, but it is highly

probable that the use of these substances will be prohibited entirely in the

future. It is therefore advised that you already start searching for alternatives, if

you are currently using one of the substances on the candidate list of SVHC.

Restrictions

Restrictions may limit the manufacture, placing on the market or use of a

substance within the EU territory. If restrictions apply to a substance, either on

its own or in a mixture or article, any activity with this substance is only allowed

if it is in compliance with the restrictions set by Annex XVII of the Regulation.

This annex contains the list of all restricted substances, specifying which uses

are restricted. The former restrictions set out in the repealed Marketing and Use

Directive (76/769/EEC), e.g. the ban on asbestos and restrictions on the uses of

certain azo-dyes, have been carried over to REACH.

How are you involved?

If you produce products containing one of the substances included in Annex

XVII to the Regulation, you must meet the requirements. Otherwise your

product will not be allowed on the EU market. Since most restrictions already

existed before REACH, you may not notice any difference. Examples of

restrictions include the use of phthalates in toys and childcare products or the

ban on certain azo-dyes.

The CBI has identified the restrictions specifically relevant for your sector in

their buyer requirements modules and for specific products in their product fact

sheets. Click here to go to CBIs Market Intelligence Platform and select your

sector to see the Buyer Requirements Modules and the product fact sheets.

"Acids generated from chromium trioxide and their

oligomers. Group containing: Chromic acid,

Dichromic acid, Oligomers of chromic acid and

dichromic acid"

21 September 2017

Potassium chromate 21 September 2017

Sodium dichromate 21 September 2017

Ammonium dichromate 21 September 2017

Sodium chromate 21 September 2017

Potassium dichromate 21 September 2017

Chromium trioxide 21 September 2017

EU legislation: Chemicals REACH

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CBI has identified the following restrictions covered by REACH and relevant for

its target sectors:

Asbestos in products

Azo dyes in textile and leather

articles

Benzene in toys

Cadmium in several products

Creosote oil in wood products

Flame retardants in textiles

Lead in paints

Mercury in measuring devices

Monomer vinyl chloride used as

aerosol propellant

Nickel in piercings, ornaments and

clothing accessories

Nonyl phenols and ethoxylates

Organotin compounds

PAHs in extender oils and tyres

OctaBDE in products

Phthalates in toys and childcare

articles

Substances in decorative articles

Ugilec and DBBT in several

products

Wood preserved with arsenic

Last updated: April 2014

This document was compiled for CBI by CREM B.V.

Disclaimer CBI market information tools: http://www.cbi.eu/disclaimer