Tag Archives: REACH

CLP Next Steps Include Public Inventory Lists

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CLP Regulation passed a major CLP deadline on January 3, 2011.  CLP stands for Classification, Labeling and Packaging of chemicals. It’s a legal obligation affecting manufacturers and distributors doing business in Europe.

The European Chemicals Agency, ECHA, said that 3,114,835 notifications of 24,529 substances for the Classification and Labelling Inventory, either hazardous or subject to REACH registration, were submitted by the midnight Jan. 3 deadline, as reported by Occupational Health & Safety Magazine.

For this January 2011 deadline, the most notifications came from:

  1. Germany: over 800,000.
  2. United Kingdom: over 500,000.
  3. France: nearly 300,000.

Together over 6,600 companies were notified of at least one substance.

“It went extremely well,” said Geert Dancet, Executive Director of ECHA.  “We got over three million submissions of classifications in time by the deadline [midnight, Jan. 3, 2011].  I think it’s a real success.”

Jack de Bruijn, director of risk management, said, “We will put all the information which we have received into a public version of the inventory, which we hope to have available by May of this year.  And the main aim of that inventory is actually for companies to check whether they can better self-classify their chemicals.”

The C&L inventory. The collected data will be held in a central inventory called the C&L inventory. The public version of the inventory will also include substance identifiers and any relevant specific concentration limit or multiplying factor for each substance.

According to the REACH Regulation (Article 119.1), the C&L inventory will contain

  • The classification and labeling information on substances submitted to ECHA through REACH registrations and CLP notifications.
  • A list of substances that have harmonized classification in the EU.

ECHA says that the full database will be accessible to Member State Competent Authorities, and non-confidential information in the inventory will be made public on the ECHA’s website.

“And with that increased transparency,” said de Bruijn, “we hope that we will contribute considerably to the safer use of chemicals in Europe, in particular the chemicals which are used in workplaces and by the general public.”

Again, the classification and labeling inventory will be published in spring/summer 2011.

If a company has flagged the IUPAC name confidential, and where relevant, the Agency will publish an alternative name in the public inventory.

Missed deadline. Companies that missed the deadline and are not sure what to do may contact an advisor such as Chris Nowak at Actio for ideas that are particular for each unique business situation.  To handle the situation directly — use the CLP notification web page, which is what you would use whether you’re late notifying or not.

If you missed the deadline but act quickly, penalties may be minimal or nonexistent.  ECHA wants you to notify.  There is every impetus for ECHA to make CLP notification as reasonable as possible.  Remember: this is a relatively new mind-set as well as project to manage, so no question is too small or naive.  There are few experts, so start where you are, ask questions, and share what you learn with others who are probably wondering, too.

Background on CLP. Classification, Labeling and Packaging regulation relates to chemical substances and mixtures. It introduces into the EU the criteria of the United Nations Globally Harmonised System — also known as GHS conversion — toward classifying and labeling chemicals.

One aim of the CLP regulation is to improve the protection of human health and the environment. One way of protecting human health is by publishing criteria for defining when a substance or mixture displays properties that lead to its classification as “hazardous.”

It’s too bad the CLP Regulation has such a complicated name — the concept is quite simple.

The CLP big picture is that hazardous chemicals and mixtures, when registered under REACH Regulation, require some sort of uniform classification system; this way all participants are using consistent terms, measurement units, and pictographs. Simple.

CLP is a legal obligation, yes, but it’s also common business sense.  Of course we would would want uniform communication standards in terms of classification, labels, and packaging when it comes to hazardous materials. It sounds cost-effective, too.  OSHA estimated last year that GHS, for instance, would result in time-to-market ROI, international trade cost reduction, and savings resulting from greater job safety and less injury.

Also, we should consider cost savings from lean operations resulting from streamlined processes; never mind cost-savings in time, paper and clerical labor, and the priceless ease-of-reporting to stakeholders such as the EPA, REACH agencies, any regulatory bodies, customers, board members, the public at large.

Finally,  in standard communication documents, there are significant risk management returns to consider. No entity is really resisting CLP or GHS because it makes sense from an Environment, Health and Safety or EHS angle, as well as from the business side.

Long live the green!  Both sides of it: for the environmental stewardship folks and for the Finance department.

EPA, ECHA Enter Partnership for Chemical Data Sharing

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Arguably the two top environmental acronymn heavyweights, the US Environmental Protection Agency (EPA) and the European Chemicals Agency (ECHA) have just announced a partnership that will promote enhanced technical cooperation on chemical management activities.  This is another sign that America’s revamping of chemical regulation known as TSCA reform will likely become more REACH-like and more solidified.  The question is, how soon?

ECHA is the agency that implements the European Union’s chemical management program known as REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals).  The REACH regulation has taken the world by storm.  EPA said in a release that the newly-announced partnership is part of EPA’s commitment to “improve chemical safety.”

One of the major anticipated areas of collaboration, say the agencies, will be on the exchange of data and information.

For example, the statement of intent will promote the exchange of non-confidential information on hazards, uses, and substance identification between ECHA and EPA, including data collected under REACH and by REACH software.  The two agencies will also share criteria for managing confidential business information with the goal to increase the availability of chemical information to the public.

Overall this joining of efforts and sharing of best practices is probably a good idea.  We just hope for more efficiency rather than another dimension of beurocracy.  For more on this, see details at the EPA page.

Green Chemistry Status in California and All US States

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Green Chemistry simply means: using chemistry to reduce or eliminate the use and generation of hazardous materials. Below, we’ve provided a table itemizing which states have stages of green chemistry laws implemented.  Just scroll down.  We all need an overview sometimes.  You can download the Green Chemistry Status pdf version here.

The California Green Chemistry Initiative may be a great idea, but it started an environmental regulatory trend whereby the state regulates chemicals in manufactured products. It applies to goods made or sold in the state. The green chemistry initiatives are similar to, in particular, DfE or Design for Environment and REACH. Often, Green Chemistry focuses on children’s products. This sparks the public interest, makes legislation easier to pass, and let’s face it, it appears children are more vulnerable and susceptible to the maleffects of toxic substances, largely because of toxic attacks on youth in critical developmental stages.

Would it be ideal to have Green Chemistry be some kind of standard at the federal level? Absolutely. Manufacturers, associations, regulatory bodies and the public agree on that. In theory. But then you get the politics, infighting, lobbying, special interest groups on both the left and right — and we’re back to state and local regulations. Of course these are all different, in different stages of implementation. This spells disaster for manufacturers trying to abide by the law.

To solve the problem, we’ve created an up to date Status Table that shows the status of Green Chemistry laws, state by state.

If you have trouble seeing the table below, view and print a high-resolution pdf version. Data are current as of December 2010.

Reuters recently ran an article that pointed out:

“In addition to the health and environmental safety of these greener chemicals, green chemistry brings a competitive advantage to companies:

1. Less risk of product recalls and potential damage to company reputation
2. Cost savings gained when hazardous materials are removed to reduce the costs associated with handling, transportation, disposal and compliance of hazardous materials
3. Improved chances of greater stakeholder engagement from customers, employees, managers, and investors are achieved when a company demonstrates initiatives to reduce their negative impact on the environment
4. Cost savings from greater efficiencies in manufacturing process.”

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China RoHS Regulation Overview

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China RoHS phase I entered into force in 2007.  Phase II hasn’t really fired up yet.  MIIT – which is China’s Ministry of Industry and Information Technology — has indicated that RoHS 2 will be notified to the World Trade Organization (WTO) Technical Barriers to Trade (TBT) Committee following the current public comment period, as reported by Holland & Knight; that period ended without ado in August 2010.  The stated MIIT goal is to finalize RoHS 2 by the end of 2010. It is possible, per recent MIIT feedback, that MIIT will endeavor to have RoHS 2 enter into effect within one year of promulgation.

This means that if RoHS 2 were finalized by the end of 2010, we could possibly see RoHS 2 in effect – with labeling and information disclosure requirements applicable to the new scope of products – by the end of 2011 or early 2012.  Interestingly, Taiwan put up a new web site earlier this year to present an English-speaking version of its toxic substances control initiatives and laws.  And China released an updated version of its REACH-like chemical law earlier this year.
One requirement of China RoHS Phase I was that companies indicate on product labels whether a product contain specific restricted materials. The second phase will restrict specific substances in products.  In fact, according to China RoHS, all items shipped to China must be marked to indicate whether items contained therein are compliant or noncompliant with China RoHS.  No small order.

The Electronic Information Products (EIP) logo or other label is used to mark parts and assemblies that do not contain unacceptable amounts of substances identified by the regulations, and that are environmentally safe. (Units that do contain hazardous substances are marked with the EIP logo including an Environment Friendly Use Period [EFUP] value in years.)

There are six substances now considered environmentally hazardous by China RoHS:

* Lead
* Mercury
* Cadmium
* Hexavalent Chromium
* Polybrominated Biphenyls
* Polybrominated Diphenyl Ethers

EU RoHS vs. China RoHS. In 2006, the China’s Ministry of Industry and Information Technology or MIIT circulated the long-awaited “Management Methods for Controlling Pollution Caused by Electronic Information Products Regulation” (usually called “China RoHS”). China RoHS was developed separately from the EU regulations and is, as written, more strict in many ways. Manufacturers, importers, and some retailers fall under its scope.

China RoHS is similar to EU RoHS in that it restricts certain hazardous substances in consumer products and in packaging materials. However, the China RoHS is different from its EU counterpart in a few significant ways.

China RoHS takes on:

  1. automotive medical devices
  2. manufacturing equipment
  3. components
  4. electronics
  5. radar equipment
  6. certain raw materials
  7. packaging materials

However, China RoHS doesn’t take on home appliances and toys (although components of these products often have to comply).
China RoHS labels. However, the exact time-frame for this second phase has not yet been revealed. So far, there are four types of marks or labels required on products:

  1. A label indicating whether any of the six hazardous substances – lead, mercury, cadmium, hexavalent chromium, PBB, or PBDE – are present in the product. If they are present, another label is needed that indicates the “Environment-Friendly Use Period” (EFUP) – the date until which the hazardous substances will not leak or cause environmental pollution.
  2. A table in the manual, packaging, or documentation of the product that shows which hazardous materials are in the product and which components contain the materials. This is a much stricter requirement than the EU RoHS and may require additional testing and product research to determine.
  3. The type of packaging material used needs to be described on the outside packaging.
  4. If a EFUP label is needed, a date of manufacture must be clearly marked on the product.

There are differences between the EU and China RoHS regulations. The China regulations make everyone in the supply chain responsible for noncompliance, while only importers, manufacturers and some retailers are subject to penalties in the EU version. The China RoHS also requires more disclosure – the Certificates of Compliance from suppliers adequate under EU regulations may not be enough. If you ship affected products into China, the product will need to be tested by one of the approved labs in China and will need CCC accreditation (China Compulsory Certification). Testing for compliance might be very extensive, too; you may need to test not only every component of your product, but also the materials in every component.

Some companies are wondering if China RoHS will really be enforced. China’s record of enforcing anti-counterfeiting and intellectual property laws, for instance, isn’t the highest rated in the global landscape. And yet, it’s risky to assume that China RoHS won’t be enforced. China RoHS is written as more strict than its EU counterpart — and enforcement is random — but how thoroughly it is thus far being enforced is difficult to assess.

Timing of China RoHS Phase II. The first phase of China RoHS compliance – a phase which involves “mark and disclosure” processes for products – was implemented in February 2007. China’s Ministry of Information Industry (MII) is defining RoHS compliance in that country and may head the RoHS compliance testing. So far, the MII has not mentioned any exemptions for RoHS compliance, which means that medical and military equipment may also be tested and forced to comply with RoHS definitions.

It looks as though China will define RoHS compliance differently than the EU.  China requires all components and products that meet RoHS compliance regulations to carry a logo – a green “e” in a circle. Products and components which fail to meet RoHS compliance regulations will carry a different logo and are required to clearly list all the hazardous substances in the product. Each product not meeting RoHS compliance definitions also needs to list its Environmental Protection Use Period (EPUP), or the number of years that the hazardous substances will not leak or cause any damage or injury (under normal use of the product).

The sheer size of the Chinese tech market will make training, compliance testing, and enforcement challenging.

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