Chemicals represent a wide group of any material (substance or mixture) with a definite chemical composition and form the basis of, or are added to, a vast variety of products in everyday use. This includes paints, dyes, plastics, pesticides, additives, fertilizers, household cleaners., resp. can be found in articles such as clothes, furniture and electrical appliances etc.
In order to manage this kind of large group, significant pieces of legislation of the European Union within the chemicals industry were adopted having an impact on the way how the chemicals are safely manufactured, imported, handled, labelled, classified, controlled and tested.
REACH, as a European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of Chemicals came into force on 1st June 2007 as the consolidated version of the Regulation (EC) No. 1907/2006 and replaced a number of European Directives and Regulations with a single system.
The Globally Harmonised System / GHS is a uniform system for the classification of chemicals and mixtures and their labelling on packaging as well as in safety data sheets. In the EU, the classification and labelling of hazardous chemicals is governed by Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (the 'CLP Regulation').
The ADR is the European Agreement concerning the International Carriage of Dangerous Goods by Road. It comprises special aspects for transportation in accordance with GHS and CLP.
InterBiotox can support you with the determination of relevant endpoints for purposes of REACH legislation and the classification of substances according to GHS, CLP and ADR.
Chemicals according to REACH
The chemical legislation of REACH applies to all substances manufactured or imported into the EU in quantities of 1 tonne or more per year with very few exceptions. This applies to all individual chemical substances, preparations (mixtures composed of 2 or more chemicals) and articles (materials which go through various stages of processing before becoming the final object).
While more than 22,000 substances manufactured and used in the EU are registered as part of the REACH registration procedure, registration dossiers must contain the necessary information to establish measures to manage risks from chemicals to protect human health and the environment.
REACH tells manufacturers how they must test their chemicals for safety. Different laws cover different types of product, and abiding by these laws usually requires the use of a broad range of the testing (physico-chemical, ecotoxicity, toxicity etc).
The regulation requires manufacturers or importers of substances to register them with a central European Chemicals Agency (ECHA). Registration is supported by a set of data on that substance and the amount of information required is proportionate to the amount of substance. This information serves to enable proper assessment of the hazards and risks posed by a substance and how they can be controlled.
The testing requirements depend on a tonnage band/ production volume and the testing requirements are described in details in respective Annexes of the REACH Legislation:
Tonnage band > 1000 t per year (REACH Annex X)
Tonnage band 100 – 1000 t per year (REACH Annex IX)
Tonnage band 1 – 100 t per year (REACH Annex VII / VIII)
Laboratories of InterBioTox provide a comprehensive testing portfolio of analytical, physico-chemical, human and environmental safety studies to be performed in GLP quality and to be complied with the requirements and obligations of REACH and respective Annexes. Through our network of the laboratories and highly trained specialists we are able to provide you the GLP studies in high quality of results, efficient turnaround time and in an excellent price.
Classification and labelling identify hazardous chemicals and inform users about their hazards through standard symbols and phrases. They need to be harmonised to ensure good worldwide understanding and to facilitate the free flow of goods. InterBioTox is able to conduct many health, environmental and physico-chemical studies in compliance with GLP to meet requirements of CLP, GHS, resp. ADR.
A special part represents Nanomaterials, which are natural or manufactured substances with 50% or more of particles in the number size distribution containing particle sizes between 1 to 100 nm in at least one dimension. They are regulated by REACH and CLP because they are covered by the definition of a chemical "substance" in both Regulations. InterBioTox offers comprehensive GLP testing programmes and campaigns for assessment of nanomaterials (characterization of Nanomaterials and Nanoforms, Physical-chemical properties, Toxicity, Genotoxicity and Endocrine Properties).
We offer for your chemicals, mixtures and materials the following services:
InterBioTox offers a complete GLP analytical services for your registered substance, mixture or article incl. analytical method development and validation and routine analysis of the test concentrations in various testing matrices. A special part represent requirements for Substance Identification (Sameness). Choose the study...
InterBioTox offers the aquatic and terrestrial ecotoxicology studies on plenty of chemical substances for your environmental safety assessment, to be performed fully in compliance with principles of GLP. Choose the study...
The GLP biodegradation laboratory within the InterBioTox cluster can help you to suggest the right strategy to evaluate a potential biodegradation and persistency of your substance. Choose the study...
By ascertaining physico – chemical properties, InterBioTox provides together with toxicological and ecotoxicological properties a reliable safety assessment of various chemical substances for purposes of the REACH and CLP regulations. Choose the study...
InterBioTox promotes the clients in a selected environmental fate tests for their test substances under GLP in compliance with national and international guidelines. Choose the study...
Testing on vertebrate animals for the purpose of REACH is permitted only as a last resort. In cases where in vivo testing is not allowed, InterBioTox provides validated and approved in vitro tests as a suitable non-animal alternative for testing your substances. Choose the study...
InterBioTox peform a comprehensive mammalian / in vivo toxicology for your substances as acute, sub-chronic, chronic and, reproductive & developmental toxicology studies in GLP regime for purposes of the health safety evaluation. Choose the study...
Histopathology, as a requisite part of the mammalian toxicology studies is performed by the laboratory of InterBioTox to support an evaluation of chemical substances with respect to impacts to human health. Choose the study...
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