EU-REACH

EU-REACH

European Union regulation concerning the
Registration, Evaluation, Authorisation and
Restriction of Chemicals.

It came into force on 1st June 2007 and replaced a number of European Directives and Regulations with a single system.

Aims

Global efforts to protect humans and the environment from hazardous effects of the chemicals.

  • To provide a high level of protection of human health and the environment from the use of chemicals.
  • To make the people who place chemicals on the market (manufacturers and importers responsible for understanding and managing the risks associated with their use.)
  • To allow the free movement of substances on the EU market.
  • To enhance innovation in and the competitiveness of the EU chemicals industry.
  • To promote the use of alternative methods for the assessment of the hazardous properties of substances e.g. quantitative structure-activity relationships (QSAR) and read across.

REACH
Registration

Registration is a requirement on industry (manufacturers/importers) to collect and collate specified sets of information on the properties of those substances they manufacture or supply at or above 1 tonne per year. This information is used to perform an assessment of the hazards and risks that a substance may pose and how those risks can be controlled. This information and its assessment is submitted to the European Chemicals Agency in Helsinki. It requires that all companies producing chemical substances in the EU or importing them in quantities & gt; 1 tonne per year, will register these substances in the central database run by the European Chemicals Agency (ECHA). REACH foresees the following three registration deadlines (30.11.2010, 31.05 2013 and 31.05.2018). From 1 June, 2018 all substances subject to REACH much be registered before they are placed on the EU Market.

(OR) Only
Representative Services

Compliance with the REACH regulation is mandatory for any company with the aim to continue selling chemical substances in the EU. Companies located outside the EU need to have an Only Representative (OR) in Europe in order to be able to register their substances.

Our Only Representative service allows Non-EU companies to take part in the REACH registration process. We act as their OR carrying out all the registration work needed to submit a successful registration dossier to ECHA. In addition, we provide a long-term legal presence, client representation and carry out all the mandatory continuous data collection tasks required. Pharmegich Healthcare Limited representing more than 200 non EU campiness with successful registration.

eSDS & SDS

After the REACH and CLP legislations entered into force, the Chemical Safety Data Sheet (SDS) has become the vehicle of communication within the entire supply chain in the EU. The supplier of the substance or preparation must supply and update the SDS in accordance with Annex II of the REACH regulation and taking into consideration the CLP requirements.

In addition, for all the substances where a chemical safety report (CSR) is required, the information in the SDS must be consistent with the CSR and the relevant exposure scenarios (ESs), shall be annexed to the SDS. SDS containing ESs is commonly named as Extended SDS (eSDS). We provides companies REACH & CLP compliant SDSs as well as Extended SDSs.

Legal Guidance
and Consulting

Our legal experts are happy to help companies to anticipate and manage additional regulatory demands emanating from the different REACH processes.

Please contact on js@pharmegichealthcare.com for more information