Why 2015 Will Be a Pivital Year for Global Chemical Industry

Originally published by: Chemical WatchDecember 12, 2014

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The regulatory landscape in 2014 proved to be dynamic, with many significant changes that dramatically impacted compliance programmes and initiatives. This article will give an overview of these changes and look forward to the emerging regulations anticipated to have the greatest impact in 2015.

Gauging global RoHS

Enforced as of July 2011, the updated Restriction on Hazardous Substances (RoHS 2) expanded the scope of the original regulation to include new product categories, including medical devices. It places requirements on all actors in the supply chain in order to ensure compliance with its requirements since July. This year, the European Commission undertook a review of restricted substances, and designated others as priorities for future inclusion in RoHS, while including some as “medium” priority substances. The Commission also published a list of substances for possible restriction under RoHS in the longer term and released a REACH-RoHS “Common Understanding” document, outlining how best for REACH and RoHS procedures to resolve or avoid regulatory overlap. The next big phase for RoHS 2 will be a “catch all” category of electric and electronic equipment (EEE) that comes into effect in 2019.

Since its enactment, the EU Directive has served as the model for other regulations around the globe. India, for example, based its RoHS regulation on the EU’s, which took effect on 1 May. However, questions regarding compliance and enforcement issues still remain. The Central Pollution Control Board’s draft enforcement document is still awaiting approval from the Ministry of Environment and Forests.

This year, China announced that it will issue the revision to the Measures for Administration on the Restricted Use of Hazardous Substances in Electrical and Electronic Products. Changes to the standard include an expanded scope of product categories, renamed to “electrical and electronic products”. Enforcement will be under the Ministries of Finance, Science and Technology, and Industry and Information Technology. 

The Eurasian Economic Commission, which governs the Customs Union (Russia, Belarus, Kazakhstan), held a public consultation on a proposed RoHS regulation that ended in June. The regulation will be harmonised with EU RoHS, including substance restriction and tolerated maximum concentration levels (MCVs). Both Argentina and Malaysia have also announced draft RoHS regulations. Other jurisdictions opting to enact RoHS-inspired regulations include South Korea, California, Japan, Thailand and Vietnam.

GHS in 2014

This year saw a flourish of GHS activities across the globe. Starting on 1 January, China implemented the 4th revision of GHS as required by standard GB/T 17519-2013. The standard provides the first safety data sheets (SDS) guidance for China. On 28 January, Indonesia signed into law the Regulation of Directorate General for Manufacturing-based Industry No. 04/BIM/PER/1/2014, providing guidance for GHS compliance in Indonesia such as classification methods and confidential business information.

On 6 March, the Philippines Department of Labor and Employment published Departmental Order 136-14 (DO), only requiring employers whose place of business uses hazardous substance to comply with GHS. On 7 March, Singapore published SS 586:2014, which changed its GHS from the 2nd to the 4th revision. In April, Malaysia issued the Industry Code of Practice (ICOP), providing guidance for the industry on complying with GHS classification and the preparation of labels and SDSs. Part 1 of the ICOP includes a mandatory classification list that the industry must use when classifying chemicals. Chemicals not found on the list must be self-classified. 

On 1 June 2014, Serbia began enforcing the “Regulation on the classification, packaging, labelling and advertising of chemicals and certain products, according to the Globally Harmonized System of Classification and Labeling of the UN” (“RS Official Gazette”, No. 105/2013). The regulation is aligned with the 2nd Adaptation to Technical Progress (ATP) of the EU CLP.

Australia first published an advisory GHS Chemical Information list in June and amended it in September 2014. The list includes some GHS classification information derived from the EU CLP, while others are taken from assessments by Australian agencies.  

Taiwan GHS labeling requirement under the Ministry of Labor (No. 10302007861) became effective on 3 July, while the EPA’s Management Measures on Toxic Substances Labelling and Safety Data Sheets came into force on 11 December. As for GHS material safety data sheets (MSDSs) and labels implementation, the grace period for Phase III chemicals ends on 31 December, and all hazardous chemicals other than those on the list will have to comply with GHS from 1 January 2017.  Meanwhile, Japan has issued Industrial Standard JIS Z 7252:2014 on classification, adopting the 4th revision of GHS. 

Global GHS in 2015

Regulatory challenges for next year will be the numerous GHS activities pending around the globe.  Starting on 1 January 2015, any chemical listed in Taiwan’s phase III list must comply with GHS requirements. Following the adoption of the 4th revision of GHS, manufacturers, importers, suppliers and users in Singapore must re-classify and label existing single substance chemicals by 7 March 2015 to reflect the latest adoption. Manufacturers and importers of mixtures will have to comply with GHS requirements by 1 July 2015, while Singaporean users of hazardous materials have an additional year to comply. In the Philippines, employers and users, whose businesses involve the use of hazardous chemicals, must also comply with GHS requirements by late March 2015. The Malaysian chemical industry must comply with GHS for both single substances and mixtures, starting on 17 April 2015. 

In addition, 1 June 2015 will be a key date for the chemical industry in Turkey, the US and the EU:  All EU chemical mixtures must comply with GHS by that date. It’s also the deadline for US manufacturers, importers and employers to comply with Hazcom 2012, which requires disclosure of toxic and hazardous substances in workplaces. Distributors in the US have until 1 December 2015 for their labels to conform to a GHS format. Meanwhile, substances and mixtures in Turkey are subject to the new GHS classification and labeling requirements as mandated by the Turkey CLP (No. 28848). For products already on the market, relabelling must be done by 1 June 2015, while newly introduced products after that date will have a month to comply.

Many other countries are expected to further their GHS implementation. China is expected to release its GHS classification list late this year or early 2015. Canada issued proposed rules for adopting GHS in August and is expected to issue the final rules in early 2015. Vietnam is expected to finalise a draft regulation, requiring the classification and labeling of pesticides in accordance with GHS, in early 2015 as well. In November, Mexico issued a draft standard, NOM-018-STPS-2014, aligning the country with the 5th revised edition of GHS, once it is finalised in early 2015. The new standard will create a mandatory GHS scheme, a change from the current voluntary system. Industry will have a transition period of three years to comply with the new standard. 

Asia REACH for 2015

On 9 December, South Korea published the final presidential decree to further the objectives of the Act on Registration and Evaluation of Chemicals, “K-REACH”. The decree allows 55 use categories that companies can choose to report their products annually. It also defines “surface-treated materials” that are exempt from chemical registration. Joint registration is mandatory unless exempt.On 25 November, the Ministry of Environment issued a draft list of existing chemicals. The regulation provides a list of chemicals exempt from annual reporting, due to their low risks. The Ministry is expected to finalise all registration and reporting rules and guidance in early 2015. K-REACH registration will begin on 1 January 2015, while Taiwan will also commence its REACH regulation with pre-registration starting on 1 September 2015. 

Customs Union and New Zealand

On 1 January 2015, the Eurasian Economic Union (EEU) will replace the existing Eurasian Economic Community as the final step of the process of Eurasian integration and will add four new members (Belarus, the Russian Federation, Kazakhstan and Armenia). Kirgizstan is also expected to join the EEU in the near future. The EEU is expected to finalise many of its technical regulations on consumer products such as detergents, materials in contact with food, and other household products in 2015.  

New Zealand’s EPA announced plans to simplify the Hazardous Substances and New Organisms (HSNO) requirements by developing proposals on classification, labelling, safety data sheets and packaging. The EPA will unveil the proposals in early 2015. 

2015 global regulatory changes

Besides REACH and GHS, other upcoming chemical management activities will affect the chemical industry in many countries. Taiwan has indicated that it will finalise the existing chemical inventory by the end of this year. India is expected to finalise its National Chemical Policy in early 2015. While it is not a regulation, the policy will affect the future of chemical management in India. The draft regulation on dangerous goods is also expected to be finalised in 2015 by the Ministry of Environment and Forestry.  The Department of Industrial Works in Thailand will be working on helping local manufacturers to phase out the use of HCFCs (hydro-chloro-fluorocarbons), while the Thai FDA is working on finalising registration and reporting requirements, including revising the list of chemicals under its authority. 

US regulatory landscape for 2015

Hazcom 2012 implementation is robust with the Occupational Safety and Health Administration’s (Osha) issuing of various guidance documents and letters of interpretation. For companies dealing in conflict minerals, the second US report on the issue is due. An important note is that all products manufactured in 2015 are reportable in the 2016 calendar year, when the transition period ends. 

The Toxic Substances Control Act (TSCA) reform has stalled and its success is debatable, even with a single party in control of the US Congress. Definite changes will be coming in US state regulations. California has seen a seminal year, starting with the advancement of the implementation of the Safer Consumer Products regulations. This year, the Department of Toxic Substances Control (DTSC) released the initial list of three Priority Products as well as the draft priority products Work Plan, which outlined the product categories that will be examined and possibly subject to regulation in 2015-2017. This work plan should be finalised in early 2015 with a number of products to be named priority products next year. The Office of Environmental Health Hazard Assessment (OEHHA) implemented a new “fix it” period for Proposition 65 but with much narrower application than was originally proposed. The agency also proposed new warning labels this year with requirements like clear content labelling certain composition disclosures and adoption of GHS labelling elements. The agency is expected to finalise the proposal in 2015. 

Several major trends emerge in the US: 1) weak federal chemical laws have led to tougher state regulations, with California leading the charge; 2) stakeholder lobbying has become increasingly influential in how products are regulated; 3) product-based regulations are becoming increasingly common; 4) supply chain transparency and visibility requirements are seen in more and more regulations; 5) corporate risk management programmes are growing in their relevance. Trends 2 to 5 are also applicable globally.

 

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