REACH (European Union)

The purpose of this information is to address questions you may have regarding the products you purchase from us and about Chemipol position with respect to the Registration, Evaluation, Authorization and Restriction of Chemical substances in Europe, EC Regulation Nr. 1907/2006 (REACH).

SCOPE

The aim of REACH is ensure the chemical substances are managed consistently throughout the European Union (EU). REACH applies to all chemical substances and affects all the supply chain including manufacturers, processors, traders and substances end-users. It also applies to articles when releases substances or contains substances of concern.

It requires the registration of substances produced or imported into the EU in quantities >1 ton per year. Registrants have to submit to the European Chemicals Agency (ECHA) a technical dossiers and safety reports for each substance with necessary data for evaluation and be able to demonstrate that the substance is safe for envisaged uses and do not compromise the health and the environment.

COMPLIANCE

Chemipol completed all necessary pre-registration information on time to the ECHA for the 1st December 2008 deadline. The 30th November 2010 has come to end the Phase I for substances registration process and now Chemipol regulatory team is working for Phase II registration for the 31st May 2013 deadline.

As downstream users, we take all necessary steps and work with our suppliers to ensure that our raw materials will be supported.

Since the registration process started in 2010 and continues through 2018, it would not be prudent for Chemipol to provide statements on the registration of products in the future. During the course of evaluating a registration, the ECHA will assess which tests still need to be carried out using the information contained in the registration dossier that was submitted.

The initial assessment suggests that Chemipol product range at date will not be affected because of REACH registration requirements.

EXEMPTIONS

Certain chemical substances such as natural products, polymers, pharmaceutical substances, crop protection ingredients and biocidal active substances are under the scope of other regulations and directives does not require REACH registration and shall be regarded as being registered.

In the case of biocidal products, REACH does require registration for co-formulants when are manufactured or imported in the EU in a volume >1 ton per year. Chemipol has pre-registered any substance applicable as co-formulant of biocidal products or ensured our suppliers have carried out pre-registration in cases where we are downstream users, as appropriate.

In the case of polymers, REACH applies to the monomer. The monomer has to be registered by the manufacturer or by the polymer importer in the EU when the level of monomer is ≥ 2% on the polymer weight if the total quantity of monomer amounts to ≥ 1 metric ton per year.

USES COVERED IN REGISTRAION DOSSIERS

Chemipol is collecting downstream uses and exposure information from the clients with the objective to complete the registration dossiers or inform to our suppliers as appropriate.

Please, note that the exposure assessment and risk characterization are only required for substances classified as dangerous according to Dangerous Substances Directive 67/548/EC, or assessed to be Persistent, Bio-accumulative and Toxic (PBT) or very Persistent, very Bio-accumulative (vPvB) with regard to REACH Annex XIII. The Chemical Safety Report is only required for substances eligible for REACH registration that are manufactured or imported in the EU in volumes >10 tons per year.

TIMELINES FOR SUBMISSION OF REGISTRATIONS DOSSIERS

The registration is phased within a specific timelines for technical dossier and safety reports submission to the authority, the European Chemicals Agency (ECHA):

  • Pre-registration of existing substances for grant transitional period (1st December 2008 deadline)
  • Phase I registration (30th November 2010 deadline): substances in volumes ≥ 1000 tons/year, hazardous (*) substances in volumes  ≥ 100 tons/year, CMR (**) substances in volumes ≥ 1 ton/year.
  • Phase II registration (31st May 2013 deadline): substances in volumes of 100 to 1000 ton/year.
  • Phase III registration (31st May 2018 deadline): substances in volumes of 1 to 100 ton/year.

(*)    Hazardous to the environment, very toxic to aquatic organisms, may cause long term adverse effects in aquatic environment (N, R50/53).
(**)   Carcinogenic, mutagenic and toxic for reproduction.

For additional information please contact REACH regulatory team by email at chemipol@chemipol.com or by phone at +34 937 831 044 or by fax at +34 937 837 580.