Health, safety and environment

The EU chemicals legislation REACH (Registration Evaluation, Authorization and restriction of CHemicals) requires from all EU producers and importers of substances in scope of the legislation to prepare a registration dossier and send that to the European Chemicals Agency (ECHA) in Helsinki. 

Royal Haskoning has combined its expertise on chemistry, (eco)toxicology, risk assessment and regulatory affairs to support the REACH consortium on Citrus oils with the preparation of their registration dossiers. Citrus oils are Natural Complex Substances (NCS) derived from different Citrus fruits. The complex composition of the substances posed interesting challenges for preparation of the dossiers. In order to minimize the need for any additional (animal) testing and save time and costs, several alternative techniques, like Quantitative Structure Activity Relationships (QSAR) and read across, were applied by Royal Haskoning to obtain the necessary information. The vast amount of new guidance documents and IT tools and the complexity of the subject made the completion of the first phase of the project a very important achievement for both the client and Royal Haskoning.

Joseph Tomusange, REACH coördinator of the Citrus consortium on the project and cooperation with Royal Haskoning:

The EFEO (European Federation of Essential Oils) initiated Citrus Consortium is a group of over 50 of the largest importers and manufacturers of Citrus Oils for fragrance applications in Europe. The Consortium’s task was to ensure that we compile registration dossiers for our products so that our member companies are in compliance with the REACH Regulation. Although an industry which has a history of good communication and cooperation, the REACH Regulation presented challenges unlike those usually faced by most in our industry. Once the Consortium understood the daunting task of developing REACH dossiers, it was clear that there was insufficient expertise within the core group of Lead Registrants companies and the wider group to compile the dossiers. These essential oils that the Consortium is concerned with are Natural Complex Substances (NCS) which are defined by REACH as UVCB (Unknown or Variable Composition, Complex reaction products or Biological Materials). The method that was to be employed in the compilation of these dossiers was a test case for the strategy developed by EFEO and EFFA for the industry to tackle REACH.

In 2009, Royal Haskoning was asked to provide a proposal for the compilation of 7 dossiers employing a complex Read-Across strategy to the Oils and their constituent Chemicals and developing Chemical Safety Assessment / Chemicals Safety Report (CSA/CSR). At the end of the final quarter of 2009, Royal Haskoning was selected and began the arduous task of working together with the Consortium to create REACH dossiers. From the outset, the key stakeholders within the Consortium made it clear to Royal Haskoning that the group is made of many SMEs with limited technical resource so this would complicate data gathering, compilation, etc. In addition to this, it was essential that the Consortium kept in close communication with the Lead Registrants of Constituents linked to our Oils. In spite of these complicated conditions, Royal Haskoning has and continues to work in close partnership with the Consortium. When changes of strategy have been required at very critical times during the development of the dossiers, Royal Haskoning has always sought to accommodate the Consortium’s needs which have included the need to communicate with a wider group of stakeholders. One-to-one support was provided by Royal Haskoning to the first time Lead Registrants at critical moments prior to the 2010 registration deadline.  Being new to the process the Consortium had also to consider the level of support co-registrants required. Royal Haskoning provided additional support and assistance to the Consortium which includes but is not limited to guidance documents and webinar for the co-registrants.

The Consortium successfully achieved the registration of the two Lead Registrant dossiers for 2010 and with the planning and support that has been provided by Royal Haskoning we are sure that we will be able to produce the final five dossiers. The partnership has been fruitful for all involved and in terms of learning, the lessons learnt over the past year can be used for future Consortia that our industry develops for the REACH registration of Natural Complex Substances.

Read more about REACH services on our dedicated website.