Reporting of adverse events ONLY

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:

00420 224 910 672

(from 09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

To contact us about any other issue please call:

+420 22 491 0000or our regional offices.

Hlášení nežádoucích príhod

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:

00420 224 910 672

(09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

Pro záležitosti, které se netýkaji farmakovigilance, kontaktujte prosím recepci:

+420 22 491 0000 nebo naše další pobočky.

REACH

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.

9,000+
pre-registered substances
200+
successfully registered substances
120+
managed REACH-IT accounts
80+
represented clients as OR and TPR
200+
prepared REACH compliant SDS substances
  • Assessment of REACH requirements
  • Full REACH registration including preparation and submission of dossiers
  • Communication with Lead Registrants and ECHA
  • Maintenance of REACH-IT
  • Only Representative (OR) service for non-EU organisations
  • Third Party Representative (TPR) for EU-based manufacturers and importers
  • SIEF Management
  • Chemical Safety Reports (CSRs)
  • Chemical Safety Assessments (CSAs)
  • Safety Data Sheets (SDS)

Registration

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.

Evaluation

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.

Authorisation

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.

Other REACH obligations

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).

Scope and REACH exemptions

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.

Imports and REACH Only Representative

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:

  • Default: the EU-based importer of the goods is fully responsible for REACH compliance.
  • Alternative: a REACH Only Representative is appointed by the non-EU producer.

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 Service

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:

  • Active involvement in SIEF/Consortium after pre-registration and keeping you updated on regulatory information.
  • Issuing of documents (certificates, SVHC declaration, etc.) and communication to EU importers, downstream users and authorities in various member states.
  • Collection of up to date information on quantities exported to EU to ensure they fall within the pre-registered/registered tonnage band and submission of registration dossier in accordance with deadlines.
  • Complying data sharing under REACH and wherever necessary negotiating cost of letter of access.
  • Performing substance identity and sameness checks and analysing analytical tests requirement.
  • Preparation of chemical safety assessments and reports (CSA/R) and generation of safety data sheets (SDS).
  • Registration, notification and authorisation of substances.

Third Party Representative Service

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:

  • SIEF participation on your behalf and visibility as third party representative in REACH-IT.
  • Representation in all matters concerning SIEF or Consortium participation and management.
  • Sharing data and studies and responding to requests from other participants.
  • Advising on lead/joint submission based on substance strategic importance.
  • Single point of contact with manufacturers, importers and downstream users pre and post registration.

Registration Service

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.

CLP Regulation

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:

  • Classification and labelling of substances and preparations
  • Notification of substances to classification and labelling (C&L) inventory.
  • Preparation of safety data sheet (SDS) and extended safety data sheet (eSDS)
    • Review current SDS and labels for REACH compliance
    • Modifying and classifying existing SDS to comply with REACH and CLP
    • Identifying additional information as per regulatory requirements

If you require more information about our REACH Services