Patients should always seek the advice of a doctor or pharmacist in case of adverse events.
If you wish to report an adverse event to ELC Group s.r.o., please find the contact information below:
To contact us about any other issue please call:
Pacienti by meli vždy požádat o radu svého lékare nebo lékárníka v prípade výskytu nežádoucích príhod.
Pokud chcete nahlásit nežádoucí príhodu spolecnosti ELC Group s r.o., prosím využijte kontaktních údaju níže:
Pro záležitosti, které se netýkaji farmakovigilance, kontaktujte prosím recepci:
REACH (Registration Evaluation Authorisation Chemicals) is the European chemicals legislation applicable in all 27 EU countries along with Norway, Iceland and Liechtenstein. Most chemicals marketed in the EU (in quantities over 1 tonne per year) are subject to REACH registration unless they are explicitly exempted.
If your pan-European websites lack consistency in terms of design, content and feel, then we can help. And when it comes to multilingual packaging, labeling and instruction documentation we offer in-depth detailed knowledge that ensures full compliance with local regulatory guidelines.
Our multilingual content services include support for web content, online technical support, eLearning programs and marketing information. What’s more, we’re experts at applying our solutions across your extended supply chain – including suppliers and subcontractors.
Registration involves submitting a vast technical dossier with toxicological and eco-toxicological information, risk assessment, and recommendations on how to manage the identified risks, proposals for classification and labelling, etc.
Every substance marketed in EU in a quantity of more than 1 tonne per manufacturer or importer per year, must be registered.
Only European legal entities are entitled for registration, i.e., European chemical manufacturers,European importers and the ‘Only Representatives’ for non-European chemical manufacturers or formulators.
Dossiers for large volume substances (> 100 tons per year) may be evaluated by respective Member State authorities. As a result of this evaluation, registrants may be asked to revise parts of their registration dossier.
The REACH authorisation addresses substances of very high concern (SVHC). The substances subject to authorisation are listed in REACH Annex XIV. This annex is regularly expanded. A manufacturer or importer of this substance must obtain a permit for using a substance subject to REACH authorisation.
REACH also brings about many smaller obligations. For example: Extended Safety Data Sheets, requirements for users of chemicals and notification to ECHA of certain substances in ‘articles’ (objects).
All the substances marketed in quantities over 1 tonne per year (per legal entity), are in scope of REACH, unless they are explicitly exempted.
The biggest exemption is polymers – but this is not as good as it sounds. The polymers themselves are indeed exempted, but the monomers and most of the additives that were used to make them, are not.
Also exempted: several groups of substances that are already well regulated or well known. For example: biocidal products, radioactive substances, minerals, food and waste.
REACH only addresses European companies: EU-based manufacturers and EU-based importers.Companies based outside the EU cannot themselves do registrations, notifications or whatever is necessary for REACH compliance and therefore must appoint an EU-based Only Representative.
In the case of exports to the EU the following applies:
The REACH Only Representative takes over most of the REACH obligations from the importer. The importer becomes a ‘downstream user’; as if he is buying the products in the EU.
Only Representative is a natural or legal person established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU to fulfil the registration obligations of importers.
Non-EU companies can appoint ELC Group as their Only Representative under Article 8 provisions. Our REACH team of leading consultants advises on commercial, technical and legal aspects of regulation.
Our services include:
ELC Group can be appointed as a third party representative by an EU manufacturer, importer or, where relevant, downstream user to allow potential registrants to remain anonymous vis-à-vis other stakeholders in the data-sharing process. The manufacturer or importer making the pre registration retains full responsibility for his obligations under the regulation.
Our services include:
Registration is the process by which manufacturers and importers submit to ECHA a dossier which details the physical, chemical and toxicological properties of their substance and provides guidance on hazard, risk and safe use. A range of dossier submissions services are available at ELC Group.
The CLP Regulation (for “Classification, Labelling and Packaging”) is a European Union regulation which aligns the European Union system of classification, labelling and packaging chemical substances and mixtures to the Globally Harmonised System (GHS).
The regulation incorporates the classification criteria and labelling rules agreed at UN level, the so called Globally Harmonised System of Classification and Labelling of Chemicals (GHS). It introduces new classification criteria, hazard symbols (pictograms) and labelling phrases, while taking account of elements which are part of the current EU legislation.
The regulation requires companies to appropriately classify, label and package their substances and mixtures before placing them on the market. It aims to protect workers, consumers and the environment by means of labelling which reflects possible hazardous effects of a particular chemical. It also takes over provisions of the REACH regulation regarding the notification of classifications, the establishment of a list of harmonised classifications and the creation of a classification and labelling inventory.
Our services for CLP include: