BPA – The Data Game

Over in Europe, the Member State Committee (MSC) has agreed that the European Chemicals Agency (ECHA) should request further information on six substances. This is the first batch of substance evaluations agreed on by the MSC.

Of particular note is the now infamous BPA. BPA is a carbon-based synthetic compound. It belongs to the group of diphenylmethane derivatives and bisphenols. BPA is used to make certain plastics and epoxy resins. The MSC has determined that more information is needed in order to properly assess the world’s most notorious plastic ingredient. In the US, the FDA has reached similar conclusions.

So why did the MSC agree that ECHA should request more information on six substances? This is essentially because the currently available information is insufficient to enable adequate health and environmental risk assessments. These particular six substances listed in the Community Rolling Action Plan (CoRAP) were evaluated by Germany, France, Denmark, the United Kingdom, Belgium and Spain.

Further information on Bisphenol-A (BPA) will be requested to clarify a number of concerns. First, the MSC agreed to request a new in vitro skin absorption study to assess the risk to consumers from, for example, toys and PVC articles. Second, information on the emissions and environmental exposure of BPA will be requested in order to assess the impact on the environment. The information will help to finalize the risk assessment. It will also help to determine whether further risk management measures are needed. There are on-going studies on BPA in the US which the German authority will also take into account in the next step of the assessment on endocrine disrupting properties for humans. See also BPA and California thresholds.

Other chemicals on the list

The MSC also agreed to request further information on the reproductive toxicity of carbon tetrachloride in an extended one generation reproductive toxicity study (EOGRTS, OECD 443). (More information on worker exposure to carbon tetrachloride will also be necessary).

The MSC agreed to request further information on oligomerisation and alkylation reaction products of 2-phenylpropane and phenol (previously registered as Phenol, methylstyrenated). The information requested is a bioaccumulation study in fish to clarify the concern for potential persistent, bioaccumulative and toxic properties. A combined repeated dose toxicity (90 day) and reproductive toxicity study is also requested (EOGRTS, OECD 443) to investigate endocrine disrupting effects.

The MSC agreed to ask for further information on worker exposure to imidazole and on its reproductive toxicity effects. Information will also be requested on short-term toxicity in the environment and on mutagenicity through an in vitro study.

The MSC agreed to request further information on N,N’-bis(1,4-dimethylpentyl)-p-phenylenediamine to clarify the concerns relating to persistent, bioaccumulative and toxic properties of the substance. A soil simulation test will be requested to look at aerobic and anaerobic transformation in soil.

Finally, information will be requested on a mixture of cis- and trans- tetrahydro-2-isobutyl-4-methylpyran-4-ol to clarify concerns relating to the environment. The requested study will be a short-term growth inhibition study, followed if necessary, by a long-term toxicity study in the aquatic environment.

EU Conflict Mineral Rule — Requires Attention

Reminder: time is slimming for public feedback on an EU conflict minerals initiative.

Here’s the European Commission info page. Insider comments and notes follow below.

Insider comments and notes. The Commission says it will use results to help decide whether – and how in a reasonable and effective manner – to complement and/or continue on-going due diligence initiatives and support for good governance in mineral mining, especially in developing countries affected by conflict.

The consultation is open until June 26, 2013.

The contributions received, together with the identity of the contributor, will be published on the Internet, unless the contributor objects to publication of the personal data by checking the appropriate box in the questionnaire (see question 1.1. in the EC’s questionnaire, scroll down).

IPC’s PoV. The North American electronics association IPC believes that it may be impractical to encourage the EU to take no action and that “the best strategy is to encourage a voluntary regimen based on the OECD process,” according to a recent comment from IPC’s frontperson, Fern Abrams.

OECD process. The OECD process was developed by a multi-national group with NGO and industry participation. Although the OECD process is far from perfect, IPC and others believe it’s more flexible than Dodd-Frank and other regulatory schemes. Therefore the OECD process may be the best option in terms of not having a new/competing regulatory regimen. If interested, IPC has drafted suggestions for industry in responding to the EU’s questioning.

In the US. The US conflict mineral rule was put into place in summer of 2012. Companies are required to collect data in 2013. The first deadline for reporting is in spring of 2014.

Companies who do not yet have a compliance initiative are encouraged to contact Actio or preferred vendor. Quickly. And weigh in on the EU’s possible initiative — especially if you agree that the OECD process is preferable to the Dodd-Frank compliance requirements. Take action tout de suite. Schnell. Vlug. Rapidamente.


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

A Single European Railway: On The Right Track

A locomotive rolling down the track (photo by Migro)

The Council of the European Union (the Council) announced last week that it has reached agreement toward a directive that would establish a single European railway area.

This would-be directive is a recast of the so-called “first railway package.”  The approach consists of three* directives:

  • The development of European railways.
  • Licensing of railway undertakings.
  • Management of railway infrastructure.

“The purpose of this recast is to simplify, clarify and modernise the regulatory framework for Europe’s railway sector so as to improve conditions for investments, increase competition and strengthen market supervision in that sector,” said the Council in a statement.

Goals of the new EU railway directive. Goals of the new directive include:

  • All companies having equal access to rails.
  • Greater cooperation between regulatory bodies on cross-border issues.
  • Improved financing as a result of long-term planning/stability.
  • Incentives to modernize railway infrastructure.

In particular, the agreement reinforces the independence of railway infrastructure. This includes:

  • Railway stations.
  • Freight terminals.
  • Maintenance facilities.

The idea is to get to operational independence from the companies that use that infrastructure. The separation could be critical to allowing all companies to have nondiscriminatory access to railway-related services.

The agreement last week means that the Council agreed on basic rules for European railway and railway infrastructure companies. The basic rules would enhance investment and improve market supervision and — in theory — increase competitiveness.  The new legal act aims at improving competition between railway undertakings by making rail market access conditions more transparent.

Innovation vs. competitiveness. To wit, last month the U.S. Federal Railroad Association and U.S. Transportation Secretary Ray LaHood announced $2 billion in high-speed rail funds which would serve as an unprecedented high speed rail investment.  The money is intended to:

  • Speed up trains in the Northeast Corridor.
  • Expand service in the Midwest.
  • Provide new, state-of-the-art locomotives and rail cars.

In the first quarter 2011 there was a lot of rustling in Europe about innovations and vision, especially regarding for the railway (see High Speed Rail from London to Beijing in 19 Hours).

Suddenly the buzz has shifted in Europe to the subject of competitiveness.  In fact, on June 27, 2011 there will be an Extraordinary Council meeting on the subject of Competitiveness in the Internal Market, Industry and Research and Space. The meeting will be in Luxembourg (view agenda).

The new rail directive agreement: on the right track. Under the new Railway agreement, the rails would be more competitive with other transport options and national regulatory authorities would have more power. Specifically, regulatory authorities would have the power to impose sanctions/penalties and to audit implementations of the railway directive. Cooperation between regulators on cross-border issues would be a goal, not an exception.

This type of longer-term planning is the cornerstone of improving financing of rail infrastructure, as it will offer more certainty to investors. The directive will provide incentives to modernize infrastructure, which is the best way to make sure it happens — no one spends multiple-million euros unless provoked — at least, I probably wouldn’t.

The Recast is known in e’er-pleasant-but-airy EU-speak as the “general approach.” Last week’s agreement by the member states enables the Council to start negotiations with the European Parliament.

The European Parliament, whose approval is required for the adoption of the directive, has yet to establish its position. Parliament is expected to convene on this subject in July and September.

Again: in the last quarter there was a lot of rustling in Europe about innovations and vision, and there is now a lot of rustling on the subject of competitiveness in Europe. Are the two complementary? We’ll find out.

*For specifics on the three ingredient directives, see directives Nos. 12, 13 and 14 of 2001.
For more see http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/trans/122809.pdf

ECHA Enhances Enforcement of CLP

On Jan. 25, some 29 countries from the European Economic Area sent 70 participants to ECHA  headquarters in Helsinki to strengthen the national harmonized enforcement of CLP, reports Chris Nowak of Actio, makers of chemical management software.

“The idea is,” Nowak explained, “that if ECHA takes the time to create skilled trainers, they will cascade their knowledge through training events in their own countries.

“We’ll see how it goes.  Both the enforcement of and penalties for REACH are somewhat episodic so far. Certainly well-trained inspectors are the cornerstone for the effective enforcement of CLP and REACH; but consistent legislative parameters would be helpful, too.  Surely we’ll be discussing this in some detail in Houston next month,” Nowak said.

CLP stands for the EU Classification, Labeling and Packaging Regulation.

Look forward to seeing how the “trickle down” enforcement works out for ECHA.  Enforcement has been a tricky aspect as the Agency charges forth in its admirable efforts to manage chemicals in the marketplace.

We’ll see how it goes…”