GlobalChem 2013: Chemical regulation goes global

22 February 2013 10:30  [Source: ICB]

In many countries and regions around the world, governments are pushing ahead with tougher regulatory regimes for chemicals. The European Union has in many ways set the pace with its high profile Reach regulation that came into force in June 2007.

The phased introduction is now entering the implementation phase for chemicals of lower tonnages, ie products manufactured or sold in the EU in quantities over 100 tonnes/year.

Geert Dancet

"We found out more than half [CMRs] have not been registered, which means they are not on the market in significant quanities any more. Personally I believe this is a victory..."

Geert Dancet
Executive director, European Chemicals Agency

With the 31 May 2013 closing date getting closer for registering such chemicals, it is vital for producers and exporters to Europe to make sure they are prepared, according to European Chemicals Agency's (ECHA) executive director Geert Dancet.

Under Reach, firms that produce the same substance are expected to form a group known as a Substance Information Exchange Forum. These groups appoint a lead registrant that is expected to make an initial registration with ECHA ahead of the deadline.

According to Dancet, lead registrants ought to be preparing now to submit registration dossiers for an earlier deadline of the end of March 2013. "For lead registrants we're putting out a big call to register before the end of March. ECHA will feed back any comments on the dossier and this information will need to be communicated to the other members of the group. This is particularly important if the group is large."

Dancet says it is also important for companies to ensure they meet the European Commission's definition of a small to medium-sized enterprise (SME) before applying for a reduction in fees of 30-90%, depending on the size of the company. There have been many cases where ECHA has found out about companies falsely claiming SME status to benefit from lower fees.

Far fewer product registrations are expected to take place under the next phase of Reach. Dancet says the figures have not been confirmed, but he expects around 20,000 registrations compared with 27,000 for the first, higher tonnage, phase of Reach, which applied to substances over 1,000 tonnes/year and carcinogenic or mutagenic substances over 1 tonne/year. Around 3,000 substances are expected to be registered compared with 4,000 last time.

He adds: "Our view is that this deadline will apply mainly to big businesses, and not to such a large number of SMEs. It is the 2018 deadline (1-100 tonnes/year) that will hit SMEs more. The vast majority of registrants this time will already have experience of registration during the 2010 deadline."

Meanwhile, chemicals registered under the first deadline - those produced or imported ­in tonnages over 1,000 tonnes/year, plus carcino­genic, mutagenic or reprotoxic (CMR) ­substances over 1 tonne/year - are moving through into the other stages of Reach. The Reach acronym stands for registration, evaluation, authorisation and restriction of chemicals. Under evaluation, ECHA is targeted to analyse the compliance of 5% of the registration dossiers submitted by registrants.

According to Dancet, ECHA has now developed more powerful analytical tools that can automatically screen registrations to pick up discrepancies and has now evaluated around 636 registrations. Companies that are found to have non-compliant dossiers are usually given the option to improve them before a decision is taken. Businesses are also free to appeal a decision, and this has happened in around 2% of cases.

National enforcing authorities will ultimately take action if a company is not compliant, while ECHA has in certain situations the option to withdraw registration numbers so that it is no longer legal to produce the substance. Substances can also move to the Substances of Very High Concern (SVHC) candidate list or be subject to restrictions.


ECHA has screened all the CMRs that had to be registered by the first deadline. Dancet says: "We found out more than half of them have not been registered, which means they are not on the market in significant quantities any more. I personally believe this is a victory as it has made many companies ask if they want to carry on producing or importing toxic substances."

If an SVHC is to be kept on the market, it must be authorised for certain uses. Here firms will have to demonstrate that risks associated with the uses of these substances are adequately controlled or that the socio-economic benefits of their use outweigh the risks.

There are now 138 chemicals on the candidate list for authorisation. Dancet says: "It's the first step to substitution. It's a warning signal and enterprises should take it seriously." A certain number of those 138 substances have been included on the Authorisation List (Annex XIV). Deadlines are set for companies to apply for authorisations and after that, a "sunset" date after which products cannot be used unless granted an authorisation.

Dancet says he expects 15-20 applications for authorisation to arrive this year, adding: "There will be substances on the authorisation list for which we will receive no applications because [companies] have managed to substitute them beforehand."

To date, four new restrictions have been introduced in Annex XVII. These have been added to the current 61 entries covering hundreds of substances. Five proposals for new restrictions are in the pipeline.


Canada has announced plans to accelerate the assessment of substances under its Chemicals Management Plan (CMP), as well as to update the inventory of substances it keeps on the Canadian market.

North AmericaUnder phase two of the plan, around 1,500 chemicals will be assessed by 2016. In the longer term, 4,300 substances will be evaluated by 2020, while 1,100 are due to be covered under phase one.

The criteria for assessment include potential hazard. Products that are classified internationally for health hazards; substances produced in high volumes; and persistent and inherently toxic substances will be considered. Exposure data will also be taken into account.

So far, 13 substance groups have been identified under the CMP. Draft assessments of the first groups to go through the second phase were due by the end of 2012, with final assessments and risk management documents being published from 2014.

Meanwhile, Canada's environment ministry said in December 2012 that it is seeking data by 4 September 2013 on around 2,700 ­medium-priority substances, so that it can update its chemicals inventory.

Canada is also moving towards adoption of the Globally Harmonized System (GHS) for the classification and labelling of chemicals in the workplace and will propose amendments to the Hazardous Products Act and the Controlled Products Regulations this spring.

Both Canada and the US are aiming to implement GHS for workplace chemicals by 1 June 2015.


Chemical regulation is in its infancy in china, but major changes are due to kick in during 2013.

China's Ministry of Environmental Protection has, until now, not required the registration of the majority of chemicals manufactured or imported into the country.

North AmericaMost substances already in use are covered by a simple inventory of their chemical names and Chemical Abstracts Service numbers covering around 45,000 substances.

Until now only persistent organic pollutants regulated under the UN Stockholm Convention as well as new chemicals to the market have been regulated by the ministry.

However, a big change is coming because from 1 March 2013 companies will be required to report data on the environmental impact of chemicals to the ministry.

Two lists are also being developed and are due to be published during 2013, which will determine ­priorities for environmental management: a catalogue of "hazardous chemicals" plus a sub-list of "hazardous chemicals for priority environmental management".

Businesses that produce or sell products in the hazardous chemicals list will need to submit environmental and health-related data to the ministry.

The second list of priority chemicals will contain products already on the market that are considered to need the most regulating.

Firms will have to adhere to tougher reporting and assessment standards. This includes environmental risk assessment reporting. The ministry will then make known its decisions on the level of regulation required.

There is some ambiguity about which type of products will be included on this list.

An early version published in 2012 included persistent, bio-accumulative and toxic plus very persistent and very bio-­accumulative, but they were absent from a later version.

In another development, a pollutants release and transfer register is being proposed

Companies using or prod-ucing products that fall into the "hazardous chemicals for priority environmental management" category will be obliged to produce release and­ ­transfer reports and publish the data before 31 January each year.


Many countries in Asia lack any form of comprehensive chemicals management system. Indeed, there is even a lack of information about exactly which chemicals are being produced and used.

The first moves by many countries are taking the form of the adoption of elements of the UN's Globally Harmonized System for classification and labelling of chemicals.

North AmericaMany Asian countries are considering introducing requirements for the submission of safety data sheets and product labels following GHS. These include Malaysia, Indonesia and Vietnam.

Another element being considered is the development of national risk assessment capabilities which will ultimately allow governments to restrict the use of certain substances.

Taiwan is planning a system to require registration of for priority substances rather than all chemicals. An updated version of its existing chemicals inventory was published in December 2012 and contains 79,000 substances.

In South Korea legislation governing chemicals registration and evaluation includes the requirement for existing chemicals manufactured or imported in quantities over one tonne to be notified.

Priority Evaluation Chemicals and new chemicals will have to be registered over an eight-year period from 2015. The legislation is ­expected to be adopted later this year.

India - which has a significant chemicals industry - is creating an inventory of several thousand chemicals that are exported.

The inventory will be as a possible first step towards compiling India's first comprehensive list of all the chemicals manufactured in the country or imported.

Japan has two substance databases: one under the Industrial Safety and Health Act and another under the Chemical Substances Control Law, but the integration of the two inventories is being considered.

  • This article was produced with the assistance of information provided by Chemical Watch
  • Will Beacham is deputy editor of ICIS Chemical Business, based in Sutton, UK

By: Will Beacham
+44 20 8652 3214

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