First step is to be in compliance with the regulations.
The main and complex legislation regulating the production and use of chemicals in the European Union is Regulation (EC) no. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). REACH puts a number of obligations on companies who are involved in the chemical market but also it influences related sectors like textile production.
All companies manufacturing or importing chemical substances, weather on its own, in a mixture or incorporated into an article with intended release in the quantity equal or greater than 1 tone per year have the obligation to register each substance with the European Chemicals Agency (ECHA).
Each chemical substance or mixture placed on the European market needs to be classified and labelled in accordance with the criteria laid down in Regulation (EC) no. 1272/2008 (CLP).
Hazardous products need to have a Safety Data Sheet (SDS) issued in country national language and compliant with REACH and CLP regulations. Furthermore, products have to be notified in national Poison Centers prior to placing them on the market.
As a consulting company with over 20 years’ exerience Ecotoxicological Centers provide a full range of REACH and CLP compliance service. Let us assist you to get to know your duties:
If you’re selling the phase-in substance and you’ve made your pre-registration you will have to register your substance by 31 May 2018 if you want to stay on the market.
Registration is based on the "one substance, one registration" principle. This means that manufacturers and importers of the same substance have to submit their registration jointly. For your registration, you need to collect information on your substance and share it with the other companies registering the same substance. This applies in particular to ecotoxicological and toxicological information. How much information is needed depends on the tonnage of the substance to be registered. You are already the member of the SIEF which enables you to get in contact with other registrants. If your substance is already registered you need to contact the lead registrant to buy the authorization to use the data shared within the SIEF.Registration requires the submission of:
If the quantity of the manufactured or imported substance which you have registered reaches the next tonnage threshold you need to update your registration without undue delay. You do not need to stop your manufacturing/importing while your updated dossier is processed unless otherwise indicated by ECHA.
When updating your registration dossier you need to comply with the information requirements of the new tonnage band. If this tonnage band for substance have already been registered the data is available and can be obtained from the lead registrant by buying the letter of access. In case you are the first registrant you will have to take care of generating the data after communicating with the Agency.
ECHA should be informed through inquiry of additional information required to update a registration due to a tonnage band increase. They should inform you of the names and addresses of the previous registrants and of any relevant study summaries already submitted by them in order to share existing data and to ensure that studies on vertebrate animals are not unnecessarily repeated.
When reaching the tonnage band of 10 tonnes per year you will have to prepare the chemical safety report (CSR). In the report hazard and exposure data are considered together to assess the risk posed by a substance. The output of the CSR will be exposure scenarios with operational conditions and risk management measures for adequate risk control.Ecotoxicological Centers can assist you during the whole process. We can help you both in communication with the Agency and SIEF members and the choice for performing needed tests as well as completing and submitting the dossier. We prepare the Chemical Safety Report by the tools required by ECHA – ChESAR and IUCLID software.
When you are on the market you have to be sure that you always have up-to-date information on the substance. Substances are being reviewed all the time and new information appear that might result in putting the substance on the Candidate list or into Annexes XIV or XVII of REACH.
The identification of a substance as Substance of Very High Concern and its inclusion in the Candidate List is the first step of the authorization procedure. Companies may have immediate legal obligations following such inclusion which are linked to the listed substance on its own, in preparations and articles.
At the moment there are 173 substances identified on the Candidate list, bur every few months the list is being updated with new substances added.
If the substance is included in REACH Annex XIV you’ll not be allowed to import to UE or manufacture unless you are granted authorization by EU Commission. If it’s included in REACH Annex XVII you’ll not be allowed to import to UE or manufacture unless it is for the use that is permitted in the regulation.Ecotoxicological Centers can check all inventories for substances in your products and advise for adequate reaction. We can offer regular check-ups and reporting for any regulatory changes that might affect your products.
The chemical safety report should be completed for all substances subject to registration in quantities of 10 tonnes or more per year. CSR documents the chemical safety assessment undertaken as part of the REACH registration process, and is the key source from which the registrant provides information to all users of chemicals through the exposure scenarios.
The chemical safety assessment is carried out to demonstrate that the risks from the exposure to a substance, during its manufacture and use, are controlled when specific operational conditions and risk management measures are applied. CSA should address all the identified uses of a substance on its own (including any major impurities and additives), in a mixture and in an article. The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses.
The Chemical Safety Report can be a part of joint registration which you can buy an access to, but can be also prepared separately if a common documentation doesn’t cover your intended use of substance.
Results of the chemical safety assessment shall also be used when compiling safety data sheets for information that will be passed down the supply chain, in particular the exposure scenarios developed shall be annexed to it.Ecotoxicological Centers can perform the Chemical Safety Assessment for the substance and prepare the Chemical Safety Report by the tools required by ECHA – ChESAR and IUCLID software.
For substances registered at and above ten tonnes per year, which meet the classification criteria, each identified use of a substance should have an exposure scenario that will document all the relevant routes of exposures and releases associated with that use. Therefore if a chemical safety report was prepared for the substance then it must be communicated down the supply chain by the exposure scenario annexed to the SDS.
An exposure scenario is a set of conditions, including operational conditions and risk management measures, that describe how a substance is manufactured or used during its life-cycle, including the waste stage and the article service life, where applicable. It also describes how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. It is achieved through refinement of the operational conditions and risk management measures until the risks for humans and the environment are shown to be controlled.
The exposure scenarios may cover one specific process or use or several processes or uses as appropriate. The ES should be documented in a standardized way to accurately describe the conditions of use to promote adequate and achievable risk management measures.
Checking the quality of exposure scenarios is the part of ECHA enforcement project for year 2017.Ecotoxicological Centers will author exposure scenarios/e-SDS for majority of European countries. We provide relevant safety information about the substance supported by professional software.
The SDS should be updated as soon as new information which may affect the risk management measures, or new information on hazards becomes available.
This new information on substance might come from your supplier, might emerge from new Chemical Safety Assessment or can be connected to substance’s regulatory status. If the substance is included in Annex VI of CLP regulation and has new harmonized classification this might have an impact on the SDS. Also if the substance is listed in the Candidate List or included in Annex XIV or XVII of REACH this can be considered as relevant safety information.
To be in compliance means to keep track of all the changes and update all impacted Safety Data Sheet accordingly.Ecotoxicological Centers can prepare REACH & CLP compliant, high quality SDS and e-SDS for majority of European countries. We provide relevant safety information about the product supported by professional software. We also can offer you the complex SDS management including keeping track of all regulatory changes that might affect the SDS of your product.
If you’re selling your product in one or few EU countries and want to enlarge your market for other Member States this will require some actions from you.
First of all you need to have a Safety Data Sheet authored in an official language of the Member State where the product is put on the market and a relevant label.
Secondly for hazardous substances and mixtures you must notify to poison centers within each Member State. The way of submitting, the set of data and the competent authority collecting the data vary between Member States. Some notifications are simply a submission of a high quality SDS by email, others require your full composition submitted via dedicated web portal and the purchase of a security certificate.Ecotoxicological Centers offer you a full notification service across all European Countries – choosing the data needed for submission and communicating with authorities along with SDS authoring and label design.
To get started you have to know your substances very well.
Identify your substance or substances that are included in the mixture, preferably by CAS or EC number.Check if any of the substances :
Calculate the tonage – any substance exported in the quantity of 1 tone or more has to be registered.Ecotoxicological Centers can assist you in all activities concerning identification, database search including restricted substances screening and substance volume tracking.
REACH Regulation provides for the possibility to appoint a Third Party Representative if a company does not want to be visible during certain REACH processes, including discussions and negotiations over data and cost sharing with other potential registrants.
The REACH Third Party Representative can perform all substance-related interactions with other potential registrants in SIEFs and Consortia, manufacturers, importers, and downstream users.
If your calculated substance volume exceeds 1 tonne per year it means you need to register this substance with ECHA. Registration applies to substances on their own, substances in mixtures and certain cases of substances in articles irrespectively of whether they are hazardous or not. Chemical substances that are already regulated by other legislations such as medicines, or radioactive substances are partially or completely exempted from REACH requirements. Companies are responsible for collecting information on the properties and uses of the substances. They also have to assess the hazards and potential risks presented by the substance. This information is communicated to ECHA through a registration dossier containing the hazard information and, where relevant, an assessment of the risks that the use of the substance may pose and how these risks should be controlled.
Registration is based on the "one substance, one registration" principle. This means that manufacturers and importers of the same substance have to submit their registration jointly. On this stage it’s crutial to have reliable analytical data on the substance to confirm the substance sameness. Before you start negotiationg with the SIEF or Consortium be sure you’re dealing with the same substance. For your registration, you need to collect information on your substance and share it with the other companies registering the same substance. This applies in particular to ecotoxicological and toxicological information. ECHA's data-sharing processes (pre-registration and inquiry) will help you to get in contact with other registrants. If your substance is already registered you need to contact the lead registrant to buy the authorization to use the data shared within the SIEF.Registration requires the submission of:
The substances and mixtures have to be classified in accordance to the Regulation (EC) 1272/2008, called CLP regulation. CLP implements the UN Globally Harmonised System (GHS) for classification and labelling of chemicals into European Union.
CLP is based on the GHS but has some modifications including specific hazard statements and labelling rules. The regulation introduces also the list of substances with harmonised classification (Annex VI of the regulation). It is mandatory to apply this harmonised classification while classifying the mixture. If you supply the substance that is not harmonised and classification is based on your assesment you should then notify ECHA on the classification irrespectively of the tonnage of the substance.
Safety Data Sheet is the main tool of communicating the hazards posed by chemicals and instructing on safe use of them. Both employers and workers use it as a source of information about hazards, including environmental hazards, and to obtain advice on safety precautions. This is a mandatory document for all hazardous substances and mixtures placed on European market.
SDS format and content are defined by Article 31 and Annex II of REACH Regulation. The supplier of the substance or mixture shall provide the SDS free of charge in an official language of the Member State(s) where the substance or mixture is placed on the market.
If the chemical safety report was prepared for the substance all information in the SDS should be in accordance with the report and relevant exposure scenarios shall be annexed to the SDS. Exposure scenarios give a set of conditions, including operational conditions and risk management measures that describe how substances are manufactured or used during its life cycle and how the manufacturer or importer controls, or recommends downstream users to control exposure of humans or the environment. Exposure scenarios may cover one specific process or use or several processes or uses.Ecotoxicological Centers can prepare REACH & CLP compliant, high quality SDS and e-SDS for majority of European countries. We provide relevant safety information about the product supported by proffessional software. We also can offer you the complex SDS management including keeping track of all regulatory changes that might affect the SDS of your product.
All substances or preparations that are classified as dangerous under the CPL Regulations require a hazard label. The requirements for labeling elements are set up in the CLP regulation. Hazard information presented on the label needs to be in accordance with the information in the SDS. The label shall be written in the official language of the Member State where the substance or mixture is placed on the market,Information present on the label should include:
For detergents, aerosols and biocidal products additional rules for balelling are laid down in respective regulations.Ecotoxicological Centers offer you label design or check with regard to current regulations.
If you are placing hazardous mixtures on the EU market then they must be notified to poison centres within each Member State.
The way of submitting, the set of data and the competent authority collecting the data vary between Member States.
Some notifications are simply a submission of a high quality SDS by email, others require your full composition submitted via dedicated web portal and the purchase of a security certificate.
New Annex VIII of CLP will unify the rules for Poison Center notification. It aims to harmonise the information requirements and submission format for poison centre notifications. Unique Formula Identifier will be used as a tool to allow easy identification of the product in a medical emergency and would be recognised across Member States. New rules are expected to come into force after year 2020.Ecotoxicological Centers offer you a full notification service across all European Countries – choosing the data needed for submission and comminucating with authorities.