reach – a new chemicals regulation for the … · 2 reach registration, evaluation and...

REACH – A NEW CHEMICALS REGULATION FOR THE EU AND EEA-COUNTRIES

2265

2007

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REACH Registration, Evaluation

and Authorisation of Chemicals.

REACH is, consequently, an acro-

nym for Registration, Evaluation,

and Authorisation of Chemicals.

1) Import Importation from a

country outside EEA into the EEA

market.

2) The EEA The European Eco-

nomic Area includes both the EU

countries and the EFTA members

Norway, Iceland and Lichtenstein.

3) The EINECS list (The European

Inventory of Existing Commercial

Substances), a list of chemical

substances existing in EU member

countries 18 September 1981.

REACH is a new EU Regulation objected to improve management of

chemicals in Europe. REACH will partly replace Norwegian chemical

regulations. REACH will have an impact to a broad scope of enter-

prises, from large chemical industries to small companies that

manufacture, import, use or distribute chemicals or articles.

WHAT IS REACH?

WHAT ARE THE BENEFITS OF REACH?

REACH will give a high level of protection for human health and the environment because

more information on substances will become available to the authorities and the public.

REACH will contribute to a sustainable, innovative and competitive chemical industry.

Greater access to chemical health and environmental information will better enable you and

your customers to handle and use chemicals in a safer manner.

If you manufacture, import, use or distribute chemicals, you will now have increased

responsibility for knowledge and safety related to the use of chemicals.

WHAT ARE THE KEY ELEMENTS OF REACH THAT I SHOULD KNOW ABOUT?

REACH will impose increased responsibilities on companies regarding the knowledge and

safety related to the use of chemicals. Each company is responsible for fulfi lling the require-

ments under the regulation.

Key elements in the regulations are:

• Registration

• Evaluation

• Authorisation

• Restrictions/prohibitions

Early preparation is important to ensure that your company have the information required

to be ready for REACH. You should start preparing for REACH now!

PRE-REGISTRATION & REGISTRATION

If you manufacture and/or import1) one tonne or more of any substance annually you must sub-

mit a registration fi le, or a “dossier”, to the European Chemicals Agency (ECHA). Failure to regis-

ter means that the substance cannot be manufactured, imported or traded in the EEA area.2)

Substances already existing in the EEA market, i.e. substances on the EINECS list3), needs to

be pre-registered. For a pre-registration, only data on the substance identity, the company’s

name, address and contact person plus the amount and the deadline for registration needs to

be reported. A pre-registration is less comprehensive than a full registration. Pre-registration of

existing substances can only take place from 1st June 2008 – 1st December 2008.


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If you manufacture, import, use or distribute chemicals, you will now have increased respon-sibility for knowledge and safety related to the use of chemicals.

Early preparation is important to ensure that your company have the information required to be ready for REACH. You should start preparing for REACH now!


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Companies that do not pre-register a substance within the deadline, cannot later utilize the phase-in deadlines.

All relevant substances have to be registered before access to the EEA market is granted.

REACH will apply to all parts of the supply chain, from large chemical companies to small businesses.

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4) New substances Substances

not listed with EINEC.

5) Downstream user One who

makes use of the substance in

industrial or professional activi-

ties, and who are not a producer

or importer.

Companies that do not pre-register a substance within the deadline, cannot later utilize the

phase-in deadlines. The phase-in deadlines for complete registration are based on:

• The hazard of the chemical.

• The annual tonnage at which the substance is offered by each manufacturer or importer

on the EEA market.

After 1st June 2008 all new substances4) that are manufactured or imported, need to be

registered before they can be placed on the EEA market. New substances are regarded as

registered when the authorities have accepted a notifi cation prior to this date.

All relevant substances need to be registered before they can be placed on the EEA market.

The European Chemicals Agency (ECHA) is the chemical authority in the EU. The Chemi-

cals Agency shall maintain an inventory of all registrations and information on substances

above certain quantity or being hazardous on EEA market. The Chemicals Agency came into

operation 1st June 2007 and is located in Helsinki.

EVALUATION

All “dossiers” which have been registered may be subject to evaluation by the European

Chemicals Agency (ECHA). The Chemicals Agency will consider if the registration require-

ments are met. In addition the Agency will cooperate with the EEA authorities to assess

human health and environment hazards of certain substances.

AUTHORISATION

Authorisation will be required to use and place substances of very high concern on the mar-

ket. These substances are carcinogenic, toxic to reproduction, mutagenic or substances that

are persistent and bioaccumulate in the food chain. Once a substance is placed on the list of

substances subject to authorisation, an application for each use of the substance is needed.

The authorisation requirements apply regardless of the amount, even for substances in

amounts below one tonne per year.

RESTRICTIONS/PROHIBITIONS

This process is intended to provide a safety net to manage risks which have not been addressed by

the authorisation arrangement. Substances that are not covered by the criteria for the authorisation

system, but still represent a risk, may be subject to limitations in manufacturing or use.

WILL I BE AFFECTED BY REACH?

REACH applies to manufacturers and importers of chemical substances. REACH also

applies to downstream users5) and distributors – from painting or detergent manufacturers

and dry-cleaners to distributors of printer and metal industry. REACH will have an impact

on all parts of the supply chain, from large chemical companies to small businesses. If any

of the points below describe your company, then you should give a closer examination to

how this may impact your situation. Your responsibility will vary depending on the role your

company plays in the supply chain.

• If you are a manufacturer/importer and you manufacture and/or import substances or substan-

ces in preparations in quantities greater than 1 tonne per year, you will have the responsibility

to register those substances.

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• If you are a downstream user, you will need information from your producer or importer

on how to use the substance you have received. You are a downstream user whether you

use the substance either on its own or in a preparation as part of your business.

• If you are a producer or importer of an article, you are obliged to register all substances

above one tonne per year that is intentionally released from the article. Examples are

odour products such as erasers with odour, odour neutraliser and similar products. In

case you have a product containing more than 0.1 percent of a hazardous substance and

it exists in quantities above one tonne per year, you are required to notify the Chemicals

Agency even if the substance is not released from the product. Under certain circum-

stances, the Chemicals Agency may demand a registration of the substance.

YOU SHOULD START PREPARING FOR REACH NOW!

• Determine your status for each substance in your company. For each substance ask your-

self if you are the manufacturer, the importer, the downstream user or the distributor.

• Develop an inventory of all your substances, whether they are substances on their own, in

a preparation or in articles.

• Determine the current and future tonnage levels of each substance per year.

• Establish an inventory of which CAS6), EINECS7) and ELINCS8) numbers are assigned to

your chemicals.

• Identify the hazard classifi cation and any related hazard data regarding the substances.

• Identify and list your suppliers and/or customers, as well as their addresses.

• Determine whether you need to pre-register any of your substances, or whether your

supplier will do so.

• Examine how you actually use the chemical substances received from your supplier.

• Make sure you are fully informed about REACH activities and are getting access to all new

guidelines. This will enable you to do the essential advance planning of your REACH work.

You could start by contacting your trade organisation.

For REACH related enquiries, contact your trade organisation or SFT’s REACH-hjelp.

Web: www.sft.no/reach

E-mail: [email protected]

Phone number: +47 22 57 34 00

KEY REACH MILESTONES

The REACH regulation will be implemented as Norwegian regulation and will enter into

force when the Regulation 1907/2006 (EC) is a part of the EEA agreement. Norwegian

companies will have the same deadlines as EU companies.

1 June 2007 – REACH entered into force in EU

1 June 2007 – The European Chemicals Agency (ECHA) was established

1 June 2008 – 1 December 2008 – Pre-registration of existing substances

1 June 2008 – Registration of new substances which have not been notifi ed before

1 December 2010 – 1st deadline for complete registration of phase-in substances*

1 June 2013 – 2nd deadline for complete registration of pre-registered substances*

1 June 2018 –3d deadline for complete registration of pre-registered substances*

6) CAS (Chemical Abstract

Service ), internationally

recognised ID number.

7) EINECS (The European

Inventory of Existing Commercial

Substances), list of chemical

substances existing in EU

member countries as of

18 September 1981.

8) The ELINCS list (The European

List of Notifi ed Chemical

Substances), list of notifi ed

chemical substances put on

the European market after

18 September 1981.

* The deadlines are connected

to hazards and amounts. Read

more about this on SFT’s

REACH-hjelp.


At the REACH-hjelp you will get answers to questions about REACH, you may submit questions by e-mail or you may contact the SFT REACH-hjelp by phone.

WHAT ROLE DOES SFT HAVE?

REACH requires that the member states appoint a national competent authority (CA) for the

implementation of the regulation. In the Storting Report no. 14 (2006 – 2007) it is decided

that the Norwegian Pollution Control Authority (SFT) shall be the Competent Authority and

coordinate the follow up of REACH in Norway. SFT will coordinate the tasks with the Norwegian

Labour Inspection Authority (ATOS) and other involved authorities as the Directorate for Civil

Protection & Emergency Planning (DSB), the Norwegian Food Safety Authority (Mattilsynet)

and the Petroleum Safety Authority (Ptil).

SFT’S REACH-HJELP CONSTITUES THE NORWEGIAN HELP-DESK

On the SFT Website you will fi nd the REACH-hjelp in Norwegian. All the CA authorities of the

EEA countries are required to develop a helpdesk for REACH questions. At the REACH-hjelp

you’ll get answers to questions about REACH, you may submit questions by e-mail or you

may contact the SFT REACH-hjelp by phone. The questions will be handled by the SFT or be

canalised to the right authority for a reply. SFT may pass on diffi cult questions to the Chemicals

Agency for an explanation. All REACH countries shall coordinate their replies to such questions,

so that competition becomes equal to all market participants.

WHERE CAN I GET FURTHER INFORMATION ON REACH?

• SFT’S REACH-hjelp on www.sft.no/reach

• Contact SFT by e-mail: [email protected] or by phone: +47 22 57 34 00

• Your trade organisation

• The European Chemicals Agency web page: http://www.echa.eu

• The EU Industry Directorate: http://ec.europa.eu/enterprise/reach/index_en.htm

• EU Environment Directorate: http://ec.europa.eu/environnement/chemicals/reach/reach_

intro.htm

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More info on the SFT to be found on the SFT web page:

www.sft.no

Key info on chemicals, environmental conditions, and developments:

www.miljostatus.no/kjemikalier

SFT publication order via e-mail:

[email protected]

TA-2326/2007

ISBN 978-82-7655-525-7

Norwegian Pollution Control Authority

Post box 8100 Dep, N-0032 OSLO, NORWAY

Company address: Strømsveien 96

Phone number: +47 22 57 34 00

Fax: +47 22 67 67 06

E-mail: [email protected]

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