REACH & CLP Services
REACH the EU Regulation on Chemicals and their safe use (EC 1907/2006) came into force on the 1st of June 2007. It requires that all companies producing chemical substances in the EU or importing them in quantities > 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.
In addition, the EU Regulation on classification, labelling and packaging-CLP-aims to describe and label all the hazards presented by chemicals consistently around the world. The CLP Harmonization will also facilitate the commercialization of the chemicals by using internationally agreed classification criteria and labelling elements. This Regulation is a complement of the REACH Regulation and it also promotes global efforts to protect humans and the environment from hazardous effects of chemicals. All the hazardous substances placed in the EU market have to be notified under CLP before they enter the market.
REACH & CLP Support
We help co-registrants and lead registrants as their service provider or as Only Representative (OR) in fulfilling all REACH requirements. We have vast experience in taking companies through the different phases of the registration process including SIEF & Consortium. We provide customer with a complete Chemical Safety Report (CSR) and necessary collection of information in the supply chain, handling of third party access rights and financial transactions, completing the technical dossier and submitting it to ECHA.
Also, Reachlaw provides support and services to companies in identifying their CLP regulatory obligations and in compiling the notification dossiers, authoring labels and in the re-classification of the substances/mixtures to meet the CLP requirements
Our Support Includes
From 1 June, 2018 all substances subject to REACH must be registered before they are placed on the EU market.
Registration is one of the processes under REACH where companies are required to collect and assess information on the properties and hazards of the substances they produce or import in the EU. Companies need to prepare a joint dossier for each substance and submit this information to the European Chemicals Agency by the required deadline as follow:
- 30.10.2010: For substances imported/produced in volumes over 1000t/yr. For CRM substances over 1t/yr.
- 31.05.2013: For substances imported/produced in volumes between 100-1000t/yr.
- 31.05.2018: For volumes imported /produced between 1-100t/yr.
Are you first time REACH registrant and don’t know where to start? Would you like to out-task the whole REACH registration project or parts thereof?
REACHLaw can assist you with your registration as co-registrant or as Lead Registrant. REACHLaw has vast experience in taking companies through the different phases of the registration process including SIEF and Consortium. We provide resources and expertise for the hazard assessment, exposure assessment and risk characterization when needed. We provide the Customer with a complete Chemical Safety Report and necessary collection of information in the supply chain, handling of third party access rights and financial transactions, completing the technical dossier and submitting it to ECHA.
During the REACH registration process the consortium brings to companies an efficient way of cooperation with other registrants to fulfil the REACH requirements within the respective deadlines.
REACHLaw provides support for emerging Consortia with our legal staff drafting the necessary documentation to get your consortium running. We offer managerial support to Consortia under REACH. We ensure that the companies fulfil on time the REACH obligations, and we also facilitate communication and exchange information within the SIEF and within the members of the consortium. In addition we take care of the financial management agreed within the parties.
We perform the technical services in toxicological testing, assessing and compiling environmental effects and data packages compiling and assessing human health, and exposure data, evaluating hazard classification and labeling, exposure scenarios, risk and characterization and preparing chemical safety reports.
Authorisation is required for Substances of Very High Concern (SVHC) that are listed in Annex XIV (the Authorisation List). The aim of Authorisation is to ensure the good functioning of the internal market while assuring that the risks from SVHCs are properly controlled. Authorisations are granted only if the risks arising from their use are adequately controlled, where this is possible; if there are no alternatives available which are economically and technically viable by the Sunset Date; or if the use can be justified for socio-economic reasons.
Unless Authorisation has been granted for a specific substance for specific use(s), or the use has been exempted from the requirements for Authorisation for a certain use, substances included in Annex XIV cannot be placed on the market or used after the Sunset Date.
Who can apply for Authorisation?
Manufacturers, importers and downstream users can apply and hold Authorisations for their own uses or for uses down their supply chain. It is important to note that the rules regarding who can be the Authorisation holder may have the potential to cause supply disruptions if there are missing links in the supply chain.
What do I need in order to apply for Authorisation?
The Authorisation application needs to contain an Analysis of Alternatives (AoA), Chemical Safety Report (CSR) and we recommend to also include a Socio-economic Analysis (SEA) with every application. In addition, where appropriate, a Substitution Plan should also be provided to the authorities for their evaluation.
When should I begin to plan to apply for Authorisation?
Authorisation is a time-consuming and highly complex process requiring strategic business thinking. A poorly prepared application runs the risk of not receiving an Authorisation or having a short review period. It also requires the support of a dedicated multi-disciplinary team of experienced experts.
As a result, it is important that companies begin to approach and plan their application early. The preparation of these reports requires a substantial amount of data that may only be available to various different actors in the supply chain. The entire application preparation process, including strategy development, information collection and report compilation takes time.
Consequently, REACHLaw advise that you begin the process of preparing your application as soon as possible.
REACHLaw Support – Our 360° approach
Thanks to the experience we have gained by submitting so many applications for Authorisation already and our experience of dealing with the RAC and SEAC committees, REACHLaw has developed a standardised approach to Authorisation applications of all types. Though we understand that all applications are different, the general information needed to develop the strategy, AoA/SEA and CSR is very similar in all cases. It is, therefore, a matter of gathering the information and then defining what is the unique argument for your case.
Once we have identified the arguments to be used, we can then incorporate this into the application documents followed by Pre-submission Information Session with ECHA and then submission, once the documents meet your expectations.
REACHLaw supports our clients all the way through the Authorisation process: from project kick-off until the Commission provide your Authorisation number.
As we are based in Helsinki, the home of ECHA, we are also able to easily liaise with them and represent your interests when dealing with the authorities.
Our Support Includes:
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 pre-registration and 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.
Producers, importers and suppliers of articles located in EU, as well as the Only Representatives from non-EU suppliers of articles, have obligations under REACH. The latter actors may have the following requirements: i) registration obligations may apply if the article contains substances intended to be released with a volumes of > 1tonne/yr. ii) Notification obligations may apply if the article contains listed Substances of Very High Concern (SVHC) iii) If the article contains SVHC substances this information needs to be notified along the supply chain.
We assist companies with the following services: SVHC notification, SVHC identification, Notification-Exemption study, SVHC inventory and monitoring, article study and corporate level consulting.
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).
REACHLaw provides companies REACH & CLP compliant SDSs as well as Extended SDSs. We also provide translated SDS’s and eSDS to the official languages where the product is placed.
Our legal services help companies to anticipate and manage additional regulatory demands emanating from the different REACH processes and other product Environmental, Human and Safety- EHS- related market access restrictions globally. Additionally, we also help companies to clarify whether their substances/preparations are exempted from REACH.
Likewise, our legal experts assist our clients in the management of REACH compliance issues in the supply chain and in REACH due to diligence processes related to mergers, acquisitions and other company transactions.
REACHLaw help you with identifying your CLP regulatory obligations and with compiling the notification dossiers, authoring of labels and re-classification of your substances/mixtures to meet the CLP requirements.
Our Support Includes: