New ‘Extended’ Safety Data Sheet in REACH

Many companies use safety data sheet software for updating, searching and viewing SDSs. What surprises people is that under the REACH regulation in Europe, companies must produce something called an extended-Safety-Data-Sheet, or e-SDS.

REACH regulation is the Registration, Evaluation, Authorization of Chemicals — Europe’s famous regulatory behemoth for managing hazardous substances in the marketplace. If you use hazardous substances registered under REACH, your suppliers now have to provide you with a new, extended safety data sheet that includes exposure scenarios.

What’s an exposure scenario?

Exposure scenarios are the new, key element in safety documentation. They include safe use conditions, the operational conditions and necessary risk management measures.

In other words, exposure scenarios say, “We tested this spray paint for spraying paint, and we assume your use will be similar.” But if you want to use the spray can to blow up a balloon, that’s a different story, and for that you will need to get a new exposure scenario from the supplier. Get more detail about exposure scenarios.

What’s in the extended-SDS?

Ideally, the extended safety data sheet should cover all uses in the life cycle of the substance, from manufacture through to waste, including:

  1. Uses within your own company
  2. Uses by your customers in their processes or products, i.e. mixtures or articles
  3. Uses by companies supplied with chemicals by your customers
  4. Thus, the extended safety data sheet provided by your supplier should include:
  5. The main technical function of the substance (e.g. flame retardant, pigment, stabilizer) and the uses covered in the exposure scenarios
  6. Threshold values of the exposure levels for human health and the environment that should not be exceeded, according to the assessment made by your supplier
  7. Physicochemical data needed to carry out exposure assessments (e.g. water solubility, vapor pressure, biodegradability)
  8. One or more exposure scenarios containing practical advice on the conditions of safe use, including risk management measures and waste management measures

REACH Fees Shrink for SMEs

Last year, a review of Europe’s REACH regulation concluded that complying with REACH regulation obligations posed a disproportionate cost burden on Small to Mid-sized Enterprises, or SMEs, relative to the burden of larger companies.

Depending on the size of the company, SMEs could benefit from reductions of 35%-95% in relation to standard registration fees, and of 25%-90% in relation to standard fees for authorization requests, says IHS, a provider of global market and economic information

REACH fee increase for larger companies. However, REACH fees for larger companies will actually increase. Your company is considered large if the headcount is above 250 and revenues are higher than 50 million euros per year.

The hope is that

  1. increasing fees for larger companies and
  2. decreasing fees for small to mid-sized companies

will level the playing field, and overall the revenue paid to the European Chemicals Agency will be balanced and unchanged.

However, again. But all fees will also be adjusted for inflation. This means increased. Confused? Welcome to REACH!

I’d say don’t worry too much about the fee change, just be aware it’s happening. Changes will be rolled into REACH-IT by Friday, March 22, 2013.

REACH-IT is closed until that date for maintenance / adjustments towards a new fee structure.

REACH Review Published

So, after 5 years of REACH regulation, what is the public perception of chemicals in Europe?

The European Commission ran a “Eurobarometer” survey on the public perception of chemicals. The target sample size in most countries was 1,000 interviews. In total, 25,557 interviews were conducted.

According to the survey, citizens are generally well aware of the wide application of chemicals. 61% of Europeans say that chemicals on the EU market today are safer than 10 years ago. Furthermore, 69% of Europeans consider chemicals unavoidable for their daily life and 75% relate them to industrial innovations.

More than half of the respondents agree that chemicals can help reduce the use of natural resources. Nevertheless, only 43% of respondents agree that chemicals can contribute to a better environment. In general, Europeans are split on who’s ensuring the safety of chemical substances, thinking it’s either industry who’s responsible or public authorities. Come to think of it, it’s fair to say many insiders are confused about that too!

Chemicals in Europe are safer under REACH. All this because on Feb. 5, ECHA released the published version of the 5-Year REACH Review.

ECHA is saying that the use of chemicals in Europe has become considerably safer since the REACH regulation entered into force. More readily available information about chemical substances on the market and better targeted risk management measures mean that risks from substances registered under REACH have significantly decreased. This trend is expected to continue as industry continues to work towards finding substitutes for the most hazardous chemicals.

Five years after REACH’s entry into force, companies have now registered 30,601 files with the European Chemicals Agency (ECHA), describing the uses and properties of 7,884 chemical substances manufactured or placed on the market.

Public opinion is still warm towards REACH and its effects, according to that Eurobarometer survey published today, mentioned above.

The REACH 5-Year Review upshot. The review concludes that while some adjustments are needed, no major overhaul is required. The main points to consider are as follows:

  1. The report makes recommendations to improve REACH implementation. These include improving the quality of registration dossiers, enhancing intelligent safety data sheet management as a central risk mitigation tool, and addressing issues related to cost sharing within Substance Information Exchange Forums (SIEFs).
  2. The report calls strongly on industry to improve the quality of dossiers submitted. Based on evidence gathered by ECHA relating to the identification of substances and determination of “sameness,” the Commission services will consider options to improve the situation, including legal measures.
  3. The Commission rules out any dramatic changes to the regulation of nanomaterials in the EU in 2013.
  4. There is insufficient information to decide now if certain types of polymers should be registered so no action is expected in 2013.
  5. There are no major overlaps with other EU legislation.
  6. Considerable  efforts to develop alternative methods to animal testing have been made and will continue:  since 2007, the Commission has made available € 330 million to fund research in this area.
  7. Enforcement could be improved. As this is the responsibility of the Member States, the report recommends that Member States reinforce coordination amongst them. See previous blog post on REACH penalties.
  8. Although the report identifies a need for some adjustments to the legislation, the EC wants to ensure legislative stability and predictability for European businesses. No changes to REACH’s main terms are proposed at present.
  9. The report recommends reducing the financial and administrative burden on SMEs in order to ensure the proportionality of legislation and to assist them to fulfil all their REACH obligations.
  10. To promote the competitiveness of the European chemical industry, the Commission will soon propose to reduce registration fees for SMEs.

Next steps. There are a few itemized next steps already moving forward:

  1. The Commission will discuss the outcomes of the REACH review with the Member States and stakeholders.
  2. In cooperation with Member States and ECHA, the Commission is developing a roadmap to assess and identify substances of very high concern (SVHC). It will set out clear milestones, deliverables and the pision of work between the Commission, Member States and ECHA to place all relevant SVHC on the candidate list by 2020.
  3. The Commission will also look into greater fee reductions to SMEs to spread the financial impact of registration more evenly.
  4. The next deadline under the REACH regulation is 31 May 2013, by when industry must register all phase-in substances manufactured or imported in the EU at or above 100 tonnes a year.

Background. REACH is the Regulation on Registration, Evaluation, Authorisation and restriction of CHemicals. The REACH review examines the overall operation of REACH and the attainment of its unique set of objectives – a high level of protection of human health and the environment, the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.

From 1999 to 2009 the EU chemical industry grew slightly higher than the average rate for all manufacturing sectors, and has largely recovered from the crisis of 2008. The industry generates a positive trade balance and is particularly well-performing in high margin sectors of specialty chemicals. In 2003, when REACH was proposed, the EU was the world’s largest chemicals market with approximately 30 % of global chemicals sales. Today it amounts to about 21 %, with China now being the largest chemicals market. However the EU remains the world’s largest exporter of chemicals and over recent years the industry’s turnover has increased in absolute terms.

Review is here: http://ec.europa.eu/enterprise/sectors/chemicals/documents/reach/review2012/index_en.htm

Korea’s REACH Chemical Law

In February 2011, the South Korean Ministry of the Environment released a draft of “the Act on the Registration and Evaluation of Chemicals.” The Ministry of Environment is the South Korean branch of government charged with environmental protection. The present minister is Lee Man Ee. Notably, in addition to enforcing regulations and sponsoring ecological research, the Ministry manages the national parks of South Korea.

The new chemical restriction Act has often been called REACH-like. It will have a list of substances of concern, like REACH. The current Act on the Registration and Evaluation of Chemicals will be updated significantly by the new Act, which will regulate both new and existing substances.

The legislation is expected to come into force in 2013.

About the new Korean REACH. The new draft Act requires manufacturers and importers of chemicals to notify substances (i.e. submit data such as quantities of production or import in the previous year) to the South Korean Ministry of the Environment.  There will be a list of substances of very high concern, there will be preregistration, registration, and authorization.

Sound familiar? If you put it to your ear you can hear oceans, all the way to the land of REACH.

Korean REACH registration. Registration will apply to two categories of substances:

  1. new substances
  2. priority existing chemical substances (priority on the basis of assessed risk)

The law firm Keller and Heckman summarized the landscape recently by saying that are many favorable aspects of the Draft Act. But there are also many uncertainties, and potentially unfavorable, aspects from the perspective of U.S. industry.  We are well-advised to be alert to the following:

  1. The criteria for deciding whether substances are of priority for registration are unclear
  2. The exemptions are far fewer than they should be, given the substantial burdens
  3. The South Korean Ministry of Environment is given unbridled discretion to decide the scope of the exemptions
  4. There are significant issues surrounding provisions for maintaining the confidentiality of data
  5. There is no provision for utilizing the information already assembled under REACH in order to avoid duplication of effort
  6. The standards by which the South Korean Ministry of Environment will decide whether a substance is of concern are not specified
  7. There are many other uncertainties that should be addressed during the legislative process
  8. The deadlines for Registration are too compressed
  9. The minimum tonnage band that triggers the registration obligation is too low
  10. No procedures are set out to challenge MOE’s decisions

REACH: 54 New Substances!

Some 54 new substances have been added to the Candidate List under Europe’s REACH regulation. Download the complete list (136 substances) for your records and reference.  (No registration required to download a copy.)

The legal obligations that companies may have resulting from the inclusion of substances in the Candidate List apply to the listed substances on their own, in mixtures or in articles. Producers and importers of articles containing any of the 54 substances included in the Candidate List by December 19, 2012 have six months from December 19 to notify ECHA if both of the following conditions apply: (i) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year and (ii) the substance is present in those articles above a concentration of 0.1% weight by weight.

REACH-SVHC-LIST-DOWNLOAD

Download available here.

There are exemptions from the notification obligation if the substance is already registered for the use or when exposure can be excluded. Information on the notification of substances in articles and related submission tools, as well as a manual with instructions on how to create and submit a notification dossier are available on ECHA´s website. A webform to facilitate the submission of substances in articles notifications is also available. Nevertheless, datasets are also provided for submission of the notifications via REACH-IT. “Silver bullet” technology for REACH and similar material disclosure compliance challenges in a supply chain is also available.

The Candidate List now contains 138 substances.

China Chemical Registration

As of March 1, 2013, the following must obtain an appropriate Registration Certificate for Environmental Management Registration for Hazardous Chemicals in China:

  • newly established companies that produce hazardous chemicals
  • companies using hazardous chemicals for production purposes
  • companies importing or exporting hazardous chemical.

Registration Certificates will be issued by China’s Environmental Protection divisions and will be valid for three years. Existing companies that produce or use hazardous chemicals for production purposes have a three-year transition period to complete registration— this registration is separate from the registration required by the State Administration of Work Safety and it is said to aim at better tracking of the environmental impact caused by hazardous chemicals, rather than the health and safety impact.

Perhaps the biggest concern with the new Chinese chemical policies overall is how they add to the larger international weave of chemical restrictions, standards and regulations. The way to handle China’s hazcom rules— all of them, new and future— is to make sure that the way your company handles REACH, RoHS, Prop 65, GHS and TSCA also handles any Asian restrictions as well, from South Korea to Japan to India and China.

Newbies, look out. Newly established manufacturers must register their hazardous chemicals before completion and final acceptance of their project, while importers must register before they import a hazardous chemical for the first time. And the Registration must be complete before the final acceptance of any new construction projects or expansion projects of hazardous chemical manufacturers and users.

Legacy. Entities in China that manufacture or import hazardous chemicals must register their hazardous chemicals with China’s State Administration of Work Safety and China’s Ministry of Environmental Protection (MEP), while entities that use hazardous chemicals must register with China’s Ministry of Environmental Protection (MEP). Hazardous chemical manufacturers and users must also engage in material disclosure, that is, public disclosure of information regarding their hazardous chemicals production and use.

Information to submit when registering includes:

  1. classification and labeling information
  2. physical and chemical properties
  3. primary use
  4. hazardous characteristics
  5. safety information for storage, use and shipment
  6. emergency response measures.

In addition, hazardous chemical manufacturers must maintain a 24-hour domestic telephone hotline to provide users with emergency consulting services and technical instructions and other assistance with respect to hazardous chemical accidents. Another option is to assign the hotline to the Chinese government.

Action. In light of these regulations, the legal firm Baker & McKenzie suggests that entities in China who are manufacturing, importing, or using hazardous chemicals should consider: Designating certain employees, or creating a specific department, to be in charge of hazardous chemical registration and ongoing compliance requirements Conduct due diligence on suppliers in China who may be subject to these requirements as part of

Supply Chain Management (SCM). Rather than setting up an entire department to manage these changing compliance requirements in Asia, we would suggest subscribing to a secure SaaS software that manages compliance for you. In the end, it’s the most cost-effective way to manage fluctuating global regulations and supplier relations around them.

ECHA Modifies REACH Tonnage Calculations

In REACH news, the European Chemicals Agency (ECHA) has modified its methodology for calculating “total tonnage” bands. Make a note of it if you haven’t already.

The shortcomings in the legacy calculation methodology, ECHA is saying, arose from the fact that the REACH Regulation is based on the concept of legal entities rather than companies. To make a long story short, in some situations the old way could lead to involuntary disclosure of confidential business information.

So the agency has decided to modify the envisaged methodology for calculating aggregated tonnages.

The modification removes the “four registrants rule” before publication of tonnage band data on the ECHA website. As it was, the tonnage data— claimed confidential by a given registrant— would still be included in the calculation of aggregated tonnages if there are four or more registrants in a joint submission. This would threaten the Confidential status.

Tonnage amendment already in place  The publication of tonnage bands on ECHA’s registered substances database that took place for the first time in June.  Repeat: ECHA already took the modifications in the calculation method into account.

The “total tonnage band” is published together with other substance-specific information on ECHA’s website.

Total tonnage bands will be displayed for substances on ECHA’s registered substances database from those listed in the following table:

Tonnage chart REACH new
Table source: courtesy ECHA

 

Tonnage data will be extracted from the latest disseminated dossier of each full (non-intermediate) registration, aggregated, converted to a total tonnage band, and published on ECHA’s registered substances database. The total tonnage bands will be published for joint submissions and for inpidual submissions. Tonnage data will not be extracted from dossiers for intermediate registrations under REACH Articles 17 or 18. Tonnage data will also not be extracted from dossiers for full (non-intermediate) registrations where the tonnage band is claimed to be confidential in accordance with REACH Article 119(2)(b).

Claiming confidential Registrants have had the facility to claim their tonnage band confidential in accordance with REACH Article 119(2)(b) since June 2008. If registrants have not done so but wish to claim confidentiality for their tonnage band, they should submit an updated dossier with a confidentiality claim on the tonnage band as soon as possible.

For confidentiality claims under REACH, please note that the claim must be justified in accordance with Data Submission Manual 16, and will attract a fee. Confidentiality will only be granted where the claim is accepted as valid by ECHA. Notably, tonnage data will not be extracted from dossiers where the tonnage band is claimed confidential while the confidentiality claim is under assessment.

India’s Environmental Policy for Chemicals

Last April we wrote about India’s new manufacturing policy. They needed one then, and some say still do. Manufacturing in the land of cumin and curry has stalled. But don’t be fooled into thinking that means manufacturing is not happening at all in India — it means growth has stalled, not production.

Some wonder, rhetorically, how could Indian manufacturing have kept growing…?

Answer: by finding new markets.

Maybe you saw the news (India GDP news May 31, 2012) that India’s GDP growth slowed to 5.3% in Q1. This represents a three-year low for the nation. However, let’s not count India out just yet. Not even close. The nation, like many of its neighbors, is pausing, looking for new markets to pour its tremendous energy into.

One of those markets looks like it might be the chemicals industry.

Let’s take a look at the chemical industry (and related policy) in India.

India industrial sector growth: chemicals. In India, the chemical industry is said to be one of the oldest in the nation. It’s essential to any nation’s economic development that is based on manufacturing. In years past, India has had to import and almost-embarrassing amount of raw materials, including chemicals. Still, the Indian chemical sector is growing, estimated now to be worth about $108 billion.

Asia itself is a rising star in chemical sales. For example, over the last 10 years, Asia’s share of global chemical sales has increased by ~14%. Currently, the Indian chemical industry accounts for approximately 7% of India’s GDP. The share of industry in national exports hovers near 11%. Despite its large size and significant GDP profile, India’s chemicals industry represents only about 3% of global chemicals.

The Indian chemical industry is one of the most diversified sectors touching thousands of commercial products. As the raw materials engine in a booming manufacturing ship, the chemical industry is central to industrial and the agricultural development. The chemical industry provides essential building blocks for multiple downstream industries, such as textile, paper, paint, soap, detergent, pharmaceutical, varnish, etc. In India, the chemical sector is known to be largely based on feed stock derivatives from cracking of naphtha in oil refineries providing the building blocks, such as benzene, toluene, xylene, cresols, etc.

India environmental policy: chemical policy like REACH? India’s Ministry of Chemicals and Fertilizers has declared the need to invigorate the chemicals aspect of its environmental policy. Holding out for REACH-like* legislation might be a stretch in the near future (someday maybe). But the Ministry is talking in the direction of the safer use of chemicals. “For the protection of human health and the environment, and in order to reduce the current number of chemical-related laws,” authorities are saying.

*REACH is a European regulation, a pioneer initiative in the world on that deals with the registration, evaluation, authorisation and restriction of chemical substances, which entered into effect on June 1, 2007 in the European Union.

However, in India, the Department of Chemicals and Petrochemicals did begin a consultation process of the draft national chemicals policy in April of this year (2012). The resulting document includes a wide range of objectives and proposals.

Included in the documentation is the stated need to consolidate the “multiple legislations in India governing the chemicals industry that fall under the purview of different ministries.”

Also, according to the draft, India lacks legislation that addresses the following:

  1. the registration of substances
  2. preparation of a national inventory
  3. restrictions on hazardous substances
  4. banning of certain substances
  5. detailed classification and labeling criteria
  6. transport classification

The draft policy also calls for the creation of a “National Chemical Centre” (NCC). They would perform functions such as:

  1. draft legislation
  2. monitor its implementation
  3. monitor international trade practices
  4. identify opportunities for innovation and technology

The NCC would have a role in disseminating information about hazardous chemicals and create and maintain a chemicals inventory, which would include data on production, consumption and toxicological properties.

A second new body which the document states should also be set up under the guidance of the department is a “Chemical Standard Development Organisation”, or CSDO. They would “drive consensus regarding national requirements, including safety norms.”

Sound like REACH?  Yes — ish — in theory.  In reality though it’s light years away, in miles, sure, but mostly in time.

Resources besides those referenced above, as links:
International Labor Assn for Sustainable Development ILASD
Subscription / fee based: Chemical Watch

Green Chemistry, Oregon

Green Chemistry simply means: using chemistry to reduce or eliminate the use and generation of hazardous materials.

The California Green Chemistry Initiative is where it all began.  It applies to goods that are made or sold in a particular US state.  The green chemistry initiatives are similar to, in particular, Design for Environment and REACH.  It may be a great idea. But it has ignited a trend whereby chemicals in manufactured products are regulated at a state level. Enter Oregon.

On April 27, 2012, Oregon Gov. John Kitzhaber signed a “green chemistry” executive order.  It’s listed as Number 12-05 and is titled “Fostering environmentally-friendly purchasing and product design.”

So add this to your working list of US Green Chemistry laws, state by state.

This green chemistry order directs the Oregon Department of Environmental Quality (DEQ) to coordinate a statewide toxics reduction strategy and to build general awareness in the business community about the benefits of green chemistry.

This initiative is another sequin in the Green Chemistry gown.  There are many others.  More US states are adopting the “green” way of developing safer and more environmentally-friendly products.  The problem is that each state has its own focus, lists, and penalties.

Oregon toxic chemicals strategy

DEQ completed a draft of its Toxics Reduction Strategy in December 2011.  DEQ hopes to finalize the strategy in fall 2012.

The strategy includes a list of priority toxic chemicals.  Here’s the list:

Combustion & petroleum by-products:

  1. Polycyclic Aromatic Hydrocarbons (PAHs)
  2. Dioxins and Furans Napthalenes

Consumer product constituents:

  1. Phthalates
  2. Triclosan
  3. 4-Nonyphenol (and Nonyphenol Ethoxylates)
  4. Bisphenol A
  5. DEET

Pesticides:

  1. Diazinon
  2. Chlorpyrifos
  3. Atrazine
  4. Trifluralin
  5. Chlorothalonil
  6. Malathion
  7. Permethrin
  8. Carbaryl
  9. Pentachlorophenol
  10. Diuron
  11. Glyphosate
  12. Hexachlorocyclohexane
  13. (HCH), gamma- (Lindane) 2,4-D
  14. Propoxur (Baygon)
  15. Pendamethalin

Legacy pesticides:

  1. Dieldrin DDT (and metabolites)
  2. Chlordane (and metabolites)
  3. Aldrin
  4. Methoxychlor
  5. Heptachlor (& Heptachlor epoxide)
  6. Hexachlorocyclohexane, beta- (beta-BHC)
  7. Hexachlorobenzene
  8. Hexachlorocyclohexane, alpha- (alpha-BHC)

Flame retardants and industrial intermediates:

  1. Polybrominated Diphenyl Ethers (PBDEs)
  2. Polychlorinated Biphenyls (PCBs)
  3. Ammonia

Metals:

  1. Mercury (and methylmercury)
  2. Copper
  3. Cadmium
  4. Chromium
  5. Arsenic
  6. Lead
  7. Nickel
  8. Manganese
  9. Silver

Volatile organic compounds (VOCs):

  1. Tetrachloroethylene
  2. Benzene
  3. Ethylbenzene
  4. Trichloroethylene
  5. Dichlorobenzene, 1,4- (Dichlorobenzene-p)
  6. Toluene
  7. Formaldehyde

Oregon DEQ says it takes an integrated approach to reducing toxic chemicals and pollutants in the environment. The organization points out that chemicals can readily transfer from one part of the environment to another (e.g. mercury, which can be released to the air, deposited on the land, and run off into water bodies).

Thus, DEQ’s Toxics Reduction Strategy is a four-pronged attack:

  • Making the most efficient use of agency resources by focusing on the highest-priority toxic chemicals in a coordinated way
  • Implementing actions that reduce toxics at their source whenever feasible
  • Establishing partnerships with other agencies and organizations to increase effective use of public and private resources
  • Using environmental outcome statistics to measure the effectiveness of strategy implementation where feasible

With one more prong: The Governor’s new Green Chemistry Order.

REACH News: 8 New SVHC Intentions

In REACH related news, the European Chemicals Agency (ECHA) announced recently that the Registry of Intentions of Substances of Very High Concern has been updated with eight new intentions.  The list of intentions lets companies prepare for commenting.  It also indicates it’s time to start internal process prep in the event that a listed chemical does become regulated.

The eight new intentions of SVHCs and their CAS numbers are:REACH-ECHA-SVHC-list

  1.     Heptacosafluorotetradecanoic acid, CAS 376-06-7
  2.     Pentacosafluorotridecanoic acid, CAS 72629-94-8
  3.     Henicosafluoroundecanoic acid, CAS 2058-94-8
  4.     Tricosafluorododecanoic acid, CAS 307-55-1
  5.     Methoxy acetic acid, CAS 625-45-6
  6.     Cadmium sulphide, CAS 1306-23-6
  7.     Cadmium, CAS 7440-43-9
  8.     Cadmium oxide, CAS 1306-23-6

Obviously, cadmium is a featured intention for this, Europe’s influential chemical blacklist.  Interestingly, cadmium (along with lead) is also one of the most often requested exemptions under RoHS directive for electronics.  Just worth mentioning; may serve as reference if you’re thinking of commenting on the candidacy of cadmium for later in the process.

Pending SVHCs

As a rule, it’s important to know what is on tomorrow’s list of Substances of Very High Concern.  Best practice is know what’s pending as well as you know what’s certain.  Especially in times like these, when regulations are made bona fide and updated seemingly each week.

ECHA’s page on SVHC Intentions is here if you would like more information:  http://echa.europa.eu/registry-of-current-svhc-intentions.  Another possible action is to forward this blog post to your company’s risk management team — they will want to know.