a. What is REACH?
The European Chemicals Policy, the Regulation, Evaluation, Authorization and Restriction of Chemicals (REACH), is the regulatory paradigm for all chemical substances manufactured in and imported into the European Union and the preparations and articles in which the substances are present. REACH regulates substances, the chemical elements or compounds resulting from a chemical reaction, with few exemptions. Preparations, either a mixture or solution of two or more substances, and articles, objects that has been given a specific shape, surface or design which determines its function to a greater degree than its chemical composition, fall under REACH insofar as they contain or release substances. Provisions within the legislation mandate that all substances that either a manufacturer or an importer bring onto the EU market in volumes over 1 tonne per year will have to undergo testing to show safe use and the responsible companies will have to submit a completed registration dossier for the substance (with a prescribed set of data endpoints accounted for) to the European Chemicals Agency (ECHA) in Helsinki, Finland.
b. What are the legislations goals?
Extending from raw materials to final end products, REACH is a comprehensive legislation, seeking to build a complete and thorough risk identification and management system, so to best protect human health and promote environmental security.
By bringing together standardized sets of required information about the chemicals found within the European Union, the hope is that a businesses can better plan their activities and the population can be assured a greater level of transparency about the accepted uses of the chemicals that they come into contact with.
c. How is it being implemented?
The regulation is to be implemented over the 11 year period that began in June of 2007. The time from June 2007- June 2008 was to learn how REACH works. From June 1, 2008 - December 1, 2008 a company could pre-register a chemical, which allows a company up to 2018 to fulfil its registration requirements. (A pre-registration has to be done from an EU based entity. If a company has no official seat within the EU, then it must hire an only representative to act on its behalf.) Depending on substance's yearly production volume and classification, the phase-in period in which a REACH registration dossier must be completed and submitted, is November 30, 2010, May 31, 2013 or May 31, 2018 and require varying degrees of detail.
To take advantage of the phase in period, having already completed a pre-registration between June 1 and December 1, 2008 or within a half year after crossing the 1 ton/year exemption limit. If a company or its EU representative(s) fails to meet the pre-registration deadline for a given substance or fails to successfully submit a completed registration dossier before its due date, then it (they) will no longer be allowed to handle the substance within EU member nations.
Once a pre-registration has been completed, the pre-registered substances and their affiliated companies will be grouped together into Substance Information Exchange Forums (SIEFs) to facilitate the exchange of information and cooperation in the creation of a dossier. Companies that found themselves together in multiple SIEFs have also tended to group themselves into consortia, so to streamline the registration of similar substances. In both SIEFs and consortia, anti-trust regulations must be strictly followed and discussions limited to dossier production.
d. Are there any exceptions to REACH?
Yes, Annex IV of the regulation gives a detailed list of substances which are explicitly exempt from registration and Annex V provides further exemptions. Furthermore, polymers are excluded from registration, although their monomers must be accounted for.
e. How will the chemical market change due to REACH?
Initial doomsday predictions about the impact of the legislation have proved to be wrong. What one can expect is to notice is a harmonization of the information available about substances as a result of the dossiers produced and also a condensation of the quantity of CAS numbers due to sameness check exercises.
Not to be forgotten though is the authorization aspect of REACH. Substances that have been found to be particularly dangerous to human health or the environment or substances of very high concern (SVHC) are encouraged to be replaced where possible. Companies have to seek authorization, (i.e. show that the substance can be safely handled, risks have been controlled and no substitute is available) in order to use them.
f. What should I do?
Knowing what information needs to be communicated is the key to maintaining REACH compliance and to determine that, you need to identify the role you play in the supply chain.
As rule of thumb, a manufacturer in the EU should have a REACH compliance statement ready at hand for its business partners and have its MSDS documentation updated according to 1907/2006 EC, Article 31. If you are bringing a chemical substance onto the EU market, you should be ready to provide those two items and a minimum.
Importing chemicals from outside the European Union is only slightly trickier. In addition to asking for the same information as above, you should ask for a statement from the company’s Only Representative (O.R.) confirming that a contractual agreement is indeed in place. A supplier situated outside of the EU should include this information in their REACH Statement.
Effective communication within the supply chain regarding the development of registrations dossiers is also important. Most sector groups have developed REACH guidance documentation that helps identify exposure scenarios and provide typical use descriptor models needed for a dossier’s chemical safety report and guidance on safe use. There is no need to reinvent the wheel and it is most effective to work from and adapt what has already been provided within your industry.
g. What should I not do?
It is important to remember that REACH is a new regulation. It is new to industry, the regulators tasked with its enforcement and ECHA (which also happens to be a new agency). Neither the regulators nor the agency are intending to destroy business but are there to instead to foster a new era of chemical risk management in the EU.
Questions regarding use descriptor models, exposure scenarios, pre-registration numbers and registration numbers have left many businesses confused and people nervous. Consequently, a common tactic has become asking for or providing too much information or asking for signed commitments for yet to be determined decisions, an experience that can be frustrating for all involved parties.
Be moderate in the information you ask for and pass along. Registration numbers will be assigned over the course between 2010 and 2018 and every substance does not require a full risk assessment. It is the regulatory mechanisms of the Member States that are assigned to enforce REACH. You have to trust that your business partners are honest in dealing with you and be able to show that you have done your due diligence.
a. What we have done
- We have pre-registered all the substances we produce.
- All our key raw materials pre-registered as a precautionary measure.
- All non-EU sourced raw materials were pre-registered as a precautionary measure.
- We joined four consortia, three of them as founding members.
- We have served as lead registrant for two substances on the behalf of two consortia and successfully submitted our dossiers in the autumn of 2010.
- For two of our 2013 substances we will again serve as lead registrant.
b. How we manage purchasing and sales
Purchasing – With the approval or re-approval process of each and every raw material, the checklist includes a request for an updated REACH statement. We will not purchase any product until the statement is received.
Sales – We have a set of statements included in our integrated management system that anticipates and answers the majority of questions we receive regarding REACH. The statements are regularly updated to reflect any new developments. In the case of any additional questions, our regulatory affairs department is always glad to offer its assistance.
c. Our deadlines
- 2010 – In the autumn of 2010 we served as the lead registrant and registered the two primary substances in our rubber department, a zinc salt and a pentaerythritol ester.
- 2013 – We are currently working on additional registrations for our rubber department, in addition to the first substance in a silicone department and are active in all four of our consortia.
- 2018 – We anticipate that the majority of our REACH registrations will be completed well ahead of this last deadline.
d. Our leadership roles
- We have taken the role of lead registrant for two 1000+ ton substances
- We are founding members of the Zinc Salts of Fatty Acids REACH Consortium.
- We are founding members of the Fatty Esters Umbrella Consortium
- We are founding members of the Metal Carboxylates REACH Consortium
- Members of the Fatty Alcohol Amides REACH Consortium
e. Contact information
Mr. Dr. Volker Börger and Mr. Arturo Blohm
a. What is CLP?
The Regulation on Classification, Labelling and Packaging of Substances and Mixtures (EC1272/2008), or the CLP Regulation, is the EU’s adoption of the UN’s Globally Harmonized System (GHS). CLP affects all companies importing or manufacturing chemicals into the European Union. CLP is intended to simplify the communication of information about chemical hazards worldwide and reduce the regulatory burden and promote efficiency. It includes a new standardized classification criterion, hazard symbols and labelling phrases, which in harmony with REACH, will define the future chemical regulatory climate.
b. What are the legislations goals?
CLP applies to the classification, labelling and packaging of substances and mixtures placed on the EU market. Like REACH, CLP’s goal is to better protect workers, consumers and the environment by means of ensuring clear labelling which accurately reflects a chemical or substance’s hazard. CLP refines and replaces the classification and labelling sections of REACH and brings the EU inline with GHS.
c. How is it being implemented?
CLP is being phase in over two deadlines and effects all companies either importing or manufacturing substances in the EU. At the end of 2010 Substances had to be notified to the European Chemical Agency (ECHA) using the REACH-IT web-portal. Substances will be labelled and packaged under CLP but both the existing and new CLP classification will be shown to minimize confusion. For substances already "on the shelves" at the time when CLP took effect, they will have a grace period of two years (December 2012) until they too will have to be labelled and packaged under CLP.
Come June 1, 2015 mixtures (i.e. a chemical product composed of two or more substances) will also have to be classified, labelled and packaged under CLP, although a company can choose to implement CLP sooner. If that is the case, then both the existing and new CLP classification will be shown but the mixture will be labelled and packaged according to CLP. As with substances, mixtures already "on the shelves" at the time when CLP took effect will have a grace period of two years (June 2017) until they too will have to be labelled and packaged under CLP.
a. What we have done
Along with all the substances we manufacture, all those we import from outside the EU were registered into the REACH-IT System and all our documentation for substances has been updated. We have also begun revising the documentation for our mixtures and anticipate to have completed the transition well head of the 2015 deadline. In short, we have fulfilled our obligations and will continue to do so.
b. What changes can you expect
All our substances will have new CLP compliant safety date sheets made available and over the course of the next few years, our mixtures too will be receive new documentation. Furthermore, pictograms and warning labels will be changing to those provided in the CLP legislation. Please feel free to contact us to ensure that you have the updated version of our documentation or if you have any additional questions.
c. Contact information
Mrs. Dr. Maryam Bahaji