The complexity of China’s regulatory management for chemicals poses serious issues for both authorities and industry alike. Usually new legislation is unveiled without adequate supporting documents and normative guidance. This results in widespread confusion invariably leading to an industrial lag phase where enterprise is slow to adapt and innovation is minimal.
During this year’s Chemical Regulatory Annual Conference (CRAC) in Shanghai, I had a chance to catch up with influential industry stakeholders and hear the views from the other side of the regulatory red tape and luckily get a chance to gather some choice tidbits on the most efficient coping strategies enterprises should adopt when these issues occur.
Preventing compliance obstacles due to negligence
HazChem registration under SAWS Order 53 was launched in 2012. In the first half of 2013, though approximately 2,000 companies acquired registration certificates, problems emerged resulting in failure. NRCC-SAWS summarized some common problems as follows:
Incompliant SDS and labeling
Improper classification, label, precautionary statement, etc.
Lack of product standard
Incompliant emergency telephone number
Unstandardized data filling
Too many blanks in the application form
Dr. Zhang Hongzhe from NRCC, also Manager of Qingdao Nuocheng Chemical Safety & Tech. Co., Ltd, suggested that for untested mixtures, calculation formulas and/or analytical derivations must be presented in the submitting materials. When there is no national standard for the product, any industrial standard, enterprise standard or international standard is acceptable. For other issues registrants can refer to the detailed requirements in official documents.
Active attitude towards cooperation with regulators
SAWS Order 60 under Decree 591 came into force in September 2013 addressing the identification and classification of unknown physical hazards for chemicals manufactured and imported in China. Practical implementation of Order 60 is still under development with some essential parts awaiting supplementation or improvement. (See Chemlinked report: Navigator of the Physical Hazard Identification and Classification of Chemicals in China)
Dr. Crane Ji from Huntsman shared his experience in physical hazard identification and classification of mixtures. He suggested that companies should provide regulators with detailed data collected from either the supplier or production QCs. In a nutshell, the more relevant information gathered prior to dossier submission the better. Sometimes the enterprises gather more senior experts than the authority does. When disputes of the identification or classification results occur, communication, through which displays mutual understanding and support, is a good way to reach an agreement.
Readiness to cope with future regulatory and governmental action
Unlike government’s rigid working protocols, enterprises can be much more flexible in decision making. Once a company’s regulatory ducks are in a row and fully compliant with mandated requirements, lateral thinking can open up certain wiggle room for continued growth and innovation in spite of regulatory hurdles. Dr. Victor Fan, AP region regulatory compliance program manager from Intel Corp., urges industry to adopt such a flexible approach, use foresight to identify future regulatory trends and put in place measures to meet these new demands.
The absence of DEHP, a widely used plasticizer, in the recently promulgated Inventory of Hazardous Chemicals (Draft Version) caused widespread public concerns due to 2011 Taiwan food scandal and the 2012 incident on plasticizer in China’s brand liquor. Apart from its illegal use as a food additive, DEHP uptake from food and water with plastic packages, skin contact or inhalation also exhibits significant negative impact on human health. Therefore, US FDA prohibits use of DEHP-containing packaging for foods that contain fat or oil. The US EPA limits for DEHP in drinking water is 6 ppb. The US agency OSHA's limit for occupational exposure is 5 mg/m3 of air. Under EU REACH, DEHP is considered to be a chemical of very high concern, and will be banned from February 2015. Several countries have banned DEHP from toys. China regulators have also been called into question over their rather lax regulation of phthalate. Therefore, relevant manufactures and suppliers should pay attention to products containing DEHP and be fully aware of latest legislative progress.
Sustainability outweighs commercial profits
A regulatory framework driven by market forces and shaped by research data generated globally will foster a dynamic regulatory system where only safe and environmentally friendly products proliferate. Consumer demand for greener products and heavy lobbying of governments to prioritize environmental health and safety have forced regulatory intervention and consequently created an environment where enterprise must continually innovate. Prioritizing sustainability not only helps the environment but now is a major driving force of innovation in the industry making a greener future possible for all.
