What is REACH?

REACH is the new European Union Directive regarding chemicals valid from 1 June 2007. Its main principles are as follows:

• Registration procedure of the chemicals
• Evaluation of the recording documents and evaluation of materials
• Authorization of the materials in a very important manner
• Restriction and prohibition of materials in a very important manner
Regulation published by the European Parliament and Union (EC) No. 1907/2006
• Registration
• Evaluation
• Authorization
• Restriction of Chemical substances

 

Who are the responsible parties?

Producers carrying out export within the European Union and to the European Union are liable to evidence the safety of the chemical substances.

 

What are the impacts of REACH?

REACH is necessary for all producers and exporters carrying out production or export on their own name (in quantities more than 1 ton/year). Every material should be registered (except for those excluded from registration). No authorization will be given for production or export not registered in terms of firms. This situation is valid for the corporations carrying out export within the European Union and to the European Union. According to REACH, registration does not contain preparations. In spite of this, the registration is required in substances being at preparation stage.

The main rule is this: “No data – No work”

What is the Authorized Representative?

Any producer, importer and sub-user may appoint any third party as its representative, for instance, due to critical data protection. In this case, the identities of secret producers, importers and sub-users should not be disclosed to applicants.

What is Sub-User?

Sub-User using another substance other than that of producer or importer may be affected by REACH for the natural or legal person established within the European Union, it itself or production preparations. Distributors and consumers are not sub-users. Sub-users should make sure that the substances they use are recorded for certain use. If the producer makes a decision on not losing the substances due to the fact that it takes into consideration the reliability of the own uses of sub-user or for the intended use, producers will contact the European Chemical Agency.

 

How is the registration made?

REACH allows for using a transition period for substances with their preliminary registration made. The transition period depends on the quantity and hazard of the substance produced.

Start Date End Date Remark

1.6.2007 REACH Validity

1.6.2008 1.12.2008 Preliminary Registration

1.1.2009 Announcement of substances with their preliminary registration made (ECHA) and estimated registration period (conditions – preliminary registration)
1.12.2010 Registration

> For production again 1 ton/year (CMR), carcinogenic, mutagenic, toxic
> 100 tons/year (N, R 50/53), environmental hazard, high toxicity for water organisms
> 1000 tons/year (other)
1.6.2013 Registration
> 100 tons/ year
1.6.2018 Registration
> 1 ton/year

 

What are the Substances excluded?

REACH is not related to products produced or imported under 1 ton/year.

1. Substances excluded from REACH
• Substances under the supervision of customs
• Non-insulated by-products
• Wastes
• Radioactive substances
• Substances under the management of a transportation

1.  Substances not requiring registration

• All substances referred to in Annex IV & V of REACH directive
• Substances registered, which are imported again
• Polymers
• Materials used for feed and within feed and feeding stuffs
• Substances used within medicines for human or animal
• Substances regulated apart from wastes

1. Substances with minor requirement in registration

• ELINCS –The substances are considered to have been registered according to REACH.
• Substances used in searches and science from registration (registration made in place of the same)

Exclusion may be up to 5 years.

Intermediaries insulated (used) in situ
Who are those to be registered?
Producers outside EC – registration thanks to a management representative within EC.
Importer - If the producer outside EC does not assign a management representative for registration, the importer should realize the registration
Producer within EC – Registration should be made
Sub-User – in case of being producer at the same time, registration
Distributor, consumer – No registration is made

 

Our REACH services

We render consultancy service for REACH practices. We carry out independent audit and product approval.
The services provided by us as an independent company are as follows:

• To be authorized representative (producers outside EC) and representation agency service (firms from EC)
• Consultancy services in REACH application
• Inventory of chemicals and analysis of lost data
• Cooperation during preliminary registration and registrations of substances (IUCLID5)
• Declaration for those related to ECHA
• Preparation of documents (document file, chemical safety report) for registration
• Review and preparation of data acquisition strategies, choosing the suitable laboratories for testing
• Preparation and update of the safety forms and instructions for use