Introduction

On 6^th December 2018, the EU-Asia Chemical Regulations Workshop – Dublin was successfully hosted by Chemical Inspection & Regulation Service Limited (CIRS) in the Clayton Hotel Ballsbridge, Dublin, Ireland. Representatives from CIRS Ireland, CIRS China, CIRS Korea, and ChemSafe Srl delivered presentations on the topic of Chemical REACH Compliance in various regions, addressing emerging issues in chemical registration and restrictions. The workshop was well attended by representatives from the Irish Health and Safety Authority, Henkel Ireland, Liqui Moly, Procter & Gamble, Chemical Watch, KFT Chemieservice, Sun Chemical, Pepsi Co, Telematic, Metco, the Commercial Section of Chinese Embassy in Ireland, the Association of Chinese Translators & Interpreters in Ireland, and the Kildare County Council. The workshop was co-sponsored by ChemSafe Srl and Horizon Risk Consultancy Ltd.

(Mr. Li Xiang, REACH Compliance Team, CIRS Ireland)

Mr. Li Xiang, part of the REACH compliance team with CIRS Ireland, gave the opening speech, outlining the role that CIRS plays in ensuring their clients comply with chemical regulations throughout a number of regions around the world. Within the Chinese, European, and Korean markets, there are some differences in the requirements for regulatory compliance and chemical registration requirements, necessitating a wide and varied knowledge base for chemical suppliers and distributors. The aim of this workshop was to provide an authoritative and technical review of the current requirements for REACH registration in the EU, China and Korea marketplaces, as well as highlighting new potential obstacles for chemical supply and safety.

(Mr. David Wan, Head of Strategy Operation, Director of Oversea Division, CIRS China)

Hazardous Chemicals Management and Registration in China

Mr. David Wan, Director of CIRS Group Oversea Division, delivered a presentation on the essential information regarding hazardous chemicals registration in China under China REACH. This presentation also included an overview of hazardous chemical regulations in China and information on recent updates to this legislation. Along with providing a clear definition of the classification of a hazardous chemical, any chemical substance which poses a higher risk or toxicity to human life or the environment, in the context of Chinese regulations, Mr. Wan explained the obligations of suppliers and distributors for mainland China. He highlighted the need for stringent safety procedures and measures for these hazardous compounds, including stricter notification types, safety requirements, handling procedures, and post-notification obligations, such as a 24-hour emergency contact service. The latest trends in hazardous chemical management were also examined, looking at the role of the registrant and responsible representative pertaining to manufacturers, suppliers, importers, and downstream users.

(Mr. Bryan Zhou, Deputy General Manager/ Senior Regulatory Consultant, CIRS Ireland)

Chemical Regulations Management in China

The management of chemical registration and regulations under China REACH must be well understood for any company within the Chinese chemical marketplace. Mr. Bryan Zhou, a senior regulatory consultant for REACH in various regions, gave a talk on China REACH, including a general introduction to the scope of registration, the relevant registration body, the Inventory of Existing Chemical Substances in China (IECSC), the various types of notification, post-notification obligations, and a comparison between China REACH and EU REACH. He explained the categorisation of existing chemical substances and new or non-existing chemical substances in the China region, as well as some cases for exemption. Mr. Zhou also gave a detailed description of the typical method of chemical notification for registered chemicals, included practical worked examples to show the correct procedure, including who in the supply chain would be required to complete the chemical notification. He also outlined the most recent updates to China REACH regulations, including the latest revisions to typical registration and notification procedures.

(Dr. Antonio Conto, European Registered Toxicologist and CEO, ChemSafe Srl)

Endocrine Disrupting Substances: A New Challenge for Companies in the Frame of EU REACH and other Regulations

Dr. Antonio Conto, CEO and Managing Director of ChemSafe Srl, delivered a presentation on the emerging topic of endocrine disrupting substances and their potential effects in consumer products. Endocrine disrupting substances (EDS), such as oestrogen-mimicking molecules, are compounds which can affect an organism’s endocrine (hormonal) system and cause hormonal imbalances and abnormalities in a certain ecosystem. While dedicated research into the long-term effects of these substances is still relatively in its infancy, Dr. Conto highlighted the fact that early prevention and restriction of these compounds can lead to a mitigation of these long-lasting environmental effects. He also explained that the type of scientific research necessary to fully understand the scope of effects EDS can have on the ecosystem must come from an interdisciplinary approach, including chemical, zoological, toxicological, molecular biological, etc, and that a final budget for this research was difficult to estimate. Dr. Conto also stressed the benefit of keeping up to date with the most recent scientific literature and policy updates to help better understand this emerging class of compounds and to help further their regulations in the near future.

(Mr. Austin McCabe, Chemical Regulatory Consultant, CIRS Ireland)

Obligations of Enterprises after EU REACH Registration and Countermeasure Proposals

Mr. Austin McCabe from CIRS Ireland gave a presentation on the requirements of companies after completing EU REACH registration, along with a brief introduction to the process of registration and notification. He highlighted the importance of the chemical dossier required for any registered chemical, and the obligations of the Only Representative (OR) within the Community. Mr. McCabe also outlined the possible reasons for non-compliance with EU regulations, such as lack of data quality or requirements, or compliance with Chemical Safety Report (CSR), and the potential penalties faced for non-compliance, including multi-million-euro fines and imprisonment for REACH violation. He also outlined the implications of missing the deadline for product registration, and the process for registering compounds after the closing date.

(Mr. Junho Lee, Director, CIRS Group Korea)

Introduction of K-REACH Updates

Mr. Junho Lee, director of CIRS Group Korea, gave a presentation on the recent updates and implementation of K-REACH for the Korean marketplace. The amended K-REACH will come into effect on 1st January 2019, and will bring with it a series of changes to the current legislation, including the addition of priority substances, product pre-registration, and chemical tonnage notification for quantities less than 0.1 tons per annum. Mr. Lee also outlined the timeline for chemical registration for chemicals of various quantities and safety concerns, as well as highlighting some potential issues with product registration, such as certain polymer compounds. The role of a registrant, including lead, active and passive members of a K-REACH Consortium, was also explained, and the obligations of a consortium, such as consortium management, data sharing, and risk analysis, were also detailed. While this new amendment brings a series of changes into effect, Mr. Lee explained the steps required for compliance with K-REACH and any updates to the current system.

(Mr. Bryan Zhou, Deputy General Manager/ Senior Regulatory Consultant, CIRS Ireland)

Comparison and Data-Sharing among EU REACH, China REACH and K-REACH

Mr. Bryan Zhou finally gave a presentation on the importance of data-sharing for REACH regulations in different regions. He outlined the differences and similarities between EU REACH, China REACH and K-REACH, such as the similarities in registrants and OR representatives, or the different requirements for CSR reporting. Mr. Zhou also outlined the methods necessary to allow for data-sharing and the best process for complying with both China REACH and K-REACH utilising data for EU REACH-registered materials. While a significant portion of data is applicable throughout the different regions, some additional testing, such as specific eco-toxicity tests or health toxicity tests, are required to be carried out by a qualified testing facility in China, and some in vitro testing carried out in EU facilities may not be applicable in K-REACH registrations. The knowledge of these differences in paramount to ensuring REACH compliance for registered substances throughout various regions.

(Q&A Session, including Dr. Majella Cosgrave from the HSA)

Q&A Session and Close of Workshop

For the Q&A session, the speakers of the day were also joined by Dr. Majella Cosgrave, senior inspector in the Chemicals and Prevention Division for the Health & Safety Authority (HSA), a representative from the competent authority in Ireland. Many interesting questions were asked for the speakers, such as technical questions concerning the differences in chemical safety testing between the various regions, and questions about the dissemination of information not only to industry representatives but the wider public, too. The workshop was highly praised by the participating delegates, and it served to provide a deeper insight into REACH regulations for other regions, helping to further global interactions and promote stronger ties between regions.

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