Q: What is your strategy for REACH?
A: Croda supports the aims of REACH to protect the environment and human health. REACH is a complex regulation that has significant business implications for manufacturing supply chains. As a chemical supplier, we intend to ensure that REACH causes a minimum of business disruption to our customers and that we actively capitalize on the opportunities that REACH presents. As a company with an established track record in Product Stewardship, we believe that REACH provides reinforcement of our ongoing programs.
Q: How is REACH managed within Croda?
A: Croda started preparation for REACH in 2004 and believe that it is central to how we make and sell chemicals. We have an Executive level Steering Committee, supported by a senior level management team made up of representatives from manufacturing, sales, R&D, regulatory and IT functions.
Overall we believe no chemical manufacturer in Europe is in a better position than Croda to manage the implementation and to take advantage of the opportunities raised by REACH.
Q: What are the timelines for implementation?
A: REACH came into force 1 June 2007. The only immediate implication was a change to the format for safety data sheets. New safety data sheets should be prepared in this format and Croda have implemented the changes. Existing data sheets will be revised to meet this format by 1 Dec 2010 in line with legislative requirements.
Other aspects of the legislation came into force from 1 June 2008 with a critical requirement to pre-register chemicals that are in use between 1 June and 1 Dec 2008.
Pre-registered substances benefit from an extended timeline for registration with deadlines of 1 Dec2010, 1 June 2013 and 1 June 2018 depending on the volume of substance manufactured and it’s hazards.
Q: What did Croda pre-register?
A: Croda pre-registered ALL substances that it manufactured or imported that qualified for phase in status regardless of where they were manufactured.
Q: What reassurances can you give me that the products you supply me will still be available under REACH?
A: Croda has successfully completed pre-registration and we are able to reassure our customers that all substances within the products supplied by Croda into Europe that fall under the REACH regulations are pre-registered for use until their required phase-in registration dates.
Croda is currently reviewing its phase-in registration plans and intends to take all commercially reasonable actions to ensure the continuity of supply of its products through timely REACH registration as well as ensuring the compliant supply of any new product offerings. For a significant number of Croda products, REACH will have only limited impact. Where a decision is taken not to register a substance, Croda will pro-actively communicate our planned actions with customers in a timely fashion to assist in minimising business disruption.
Q: What does registration involve?
A: The registration process requires industry to collect sufficient information and to use this information to determine appropriate risk management measures to be implemented by manufacturers and importers and recommend the appropriate measures to downstream users. The main tool used by industry to document that this responsibility is fulfilled is the registration dossier, which includes, for substances above 10 tonnes, a chemical safety report.
Registration is the documentation by manufacturers or importers of substances;
Q: How can I let Croda know about my uses?
A: We are asking our customers to provide information on uses via our dedicated website, www.REACHforCroda.com. The format we are using is based on the Use descriptor system described in the ECHA technical guidance document on Information Requirements and Chemical Safety Assessments.
Q: Why then do you not ask me to provide information on Process Category.
A: We intend to model all process categories as a matter of routine unless it is obvious from the sector of use and product categories reported that they are not appropriate.
Q: What is the approach that you are taking for developing and communicating exposure scenarios?
A: Where required, we are developing exposure scenario templates with the assistance of key downstream users and will make these available to all users of our products. The basis of this will be where our records show that the use of the product would be similar to that/those covered in the exposure scenario. Where exposure scenarios are necessary we may need to take an iterative approach and many need to contact you for more specific information.
Q: I did not see any Crodarom or Sederma products on the list in www.REACHforCroda.com
A: The substances in these products will automatically be assessed for personal care applications. These materials do not require registration in the first phases and so we are not actively collecting information at this stage.
Q: If I buy and use a Croda material outside of the EU (European Union), and then export a preparation or article containing that Croda material to the EU, can I rely on your substance registration to cover my imports? Will you take care of this for me?
A: Re-import of Croda products that were manufactured in Europe will be covered by the Croda registration. For products manufactured out side of Europe you will not automatically be covered and should consider making your own arrangements for registration.
Q: Are there any Substances of Very High Concern (SVHC) in Croda products
A: Croda products do not contain any of the substances on the initial Candidate List furthermore Croda do not have any products that contain > 0.1% of any Cat1 or Cat2 CMRs.
Q: Are there any substances that will be restricted under REACH present in the materials that Croda sells? What are Croda’s future plans and actions on this?
A: We do have some products that contain nonyl phenol ethoxylates. These have been restricted under the Marketing and Use directive for several years and we have worked with customers to enable reformulation to suitable alternatives where necessary. The restrictions under the Marketing and Use directive will be replaced by Annex XVIII of the REACH regulation from 1 June 2009 Annex XVIII of REACH is almost a direct transcription of the Marketing and Use directive. There was however an error in copying over the restrictions that apply to nonyl phenol ethoxylates in that the earlier derogation that allowed continued use for existing pesticides and biocides. This derogation has been re-instated in a draft update to REACH and we expect it to be passed by the European parliament during the first half of 2009.
Q: Will I need to reconfigure my supply chain if Croda will not look after my use of your substance under REACH?
A: Where a customer has communicated to Croda their use of our material (as required by REACH), we will fully assess that when developing our chemical safety report. These actions may lead to refinements in the required risk management measures, which will be communicated to customers via the extended Safety Data Sheet (SDS).
A customer who communicates their use which is supported by Croda and complies with the applicable risk management measures should have no reason to reconfigure their supply chain as a direct result of the REACH regulation.
Q: What is the overlap between the Cosmetics Directive and REACH?
A: The Cosmetics Directive will continue and will still be the main set of controls on cosmetic safety and ingredient control. Cosmetic Ingredients will require Registration under REACH but the chemical safety assessment will not need to include the risk to human health from cosmetic use since this already controlled through the Cosmetics directive. The environmental impact of use in cosmetics will need to be considered along with any risks to health or the environment from other uses.
Q: What is the relationship between authorisation under REACH and the bans and restrictions on chemicals in the Cosmetics Directive?
A: The existing list of prohibited and restricted chemicals in cosmetics will continue to be part of the Cosmetics directive. However, chemicals which fall under authorisation due to their environmental properties would have to be authorised for continued use in cosmetics by REACH.
Q: Are Pharmaceuticals exempt?
A: The granting of Marketing Authorisations for Medicinal Products will still continue to be controlled under specific legislation. Use in the final formulation will not fall under REACH for the purposes of Registration, Evaluation, as a use that needs to be notified to the supplier, or Authorisation as this would duplicate what already happens as part of the Market Authorisation.
Q: Are there any other uses that fall out of scope?
A: Use in food or feeding stuffs will not fall under REACH for the purposes of Registration, Evaluation, as a use that needs to be notified to the supplier, or Authorisation as this will still continue to be controlled under existing specific legislation.
Other uses of these chemicals will need to be considered under REACH.
Q: What is the relationship with the Detergents Regulation?
A: Unlike other application legislation, compliance with the Detergents Regulation does not lead to any exemptions under REACH. However it is worth noting that surfactants which meet the biodegradation criteria for use in detergents will be considered non persistent and so not be candidates for Authorisation under either the PBT or the vPvB category of substances of very high concern.
We believe these statements will answer the majority of customer’s REACH questions relating to Croda at this stage. However, if you would like to discuss this further, please do not hesitate to contact either your local Croda sales office or the Central REACH team at eu.reach@croda.com.