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CHEMICALS – FORMALDEHYDE

 

Summary Arbete och Hälsa 2003:11

The Nordic Expert Group for Criteria Documentation of Health Risks from Chemicals and The Dutch Expert Committee on Occupational Standards 132. Formaldehyde

A Wibowo

Formaldehyde is a colourless, flammable, reactive gas, which readily polymerises, and forms explosive mixtures with air and oxygen. It is used as a raw material in chemical reactions, and as an intermediate in the manufacture of numerous products. It has also a medical application as a disinfectant or preservative.

Inhaled formaldehyde is almost completely absorbed in the upper respiratory tract in rodents. Formaldehyde is a normal metabolite in mammalians and is rapidly metabolised to formate, which may be further oxidised to carbon dioxide. Final elimination occurs via exhalation and via the kidneys.

The target organs of formaldehyde vapour are the eyes, nose, and throat. The effects of concern are sensory irritation and cytotoxicity-induced regenerative hyperplasia and metaplasia of the nasal respiratory epithelium accompanied by nasal carcinomas in rats. Weighting the total body of data 0.25 ppm formaldehyde is the LOAEL at which sensory irritation may occur in a low but significant percentage of exposed workers. The majority of short- and long-term inhalation animal studies reveal a NOAEL of 1-2 ppm. However, in a few studies slight histopathological changes of the nasal respiratory epithelium were observed at 0.3-2 ppm.

Formaldehyde is genotoxic in a variety of experimental systems, including rodents in vivo. There is overwhelming evidence that high, cytotoxic formaldehyde vapour concentrations (>=10 ppm) can induce nasal cancer in rats. A large body of data suggests an association between the cytotoxic, genotoxic, and carcinogenic effects of formaldehyde. The crucial role of tissue damage followed by hyperplasia and metaplasia of the nasal respiratory epithelium in formaldehyde carcinogenesis has been demonstrated in a convincing way. Thus, formaldehyde in non-cytotxic concentrations most probably cannot act as a complete carcinogen. However, if human exposure to formaldehyde is accompanied by recurrent tissue damage at the site of contact, formaldehyde may be assumed to have carcinogenic potential in man.

Formaldehyde-induced allergic contact dermatitis has been estimated to occur in 3-6% of the population, and skin sensitisation by direct skin contact has been induced with formaldehyde solutions. There is no consistent evidence of formaldehyde being a respiratory sensisitiser.

http://www.arbetslivsinstitutet.se/publikationer/detaljerad.asp?ID=1370

http://www.arbetslivsinstitutet.se/publikationer/en/samm_en.asp?ID=1370

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List of Issues: January 2004 issue

Persistent asthma following accidental exposure to formaldehyde

O. Vandenplas, P. Fievez, J. P. Delwiche, J. Boulanger, J. Thimpont

Online publication date: 12-Dec-2003

http://www.blackwell-synergy.com/servlet/useragent?func=showIssues&code=all

http://www.blackwell-synergy.com/servlet/useragent?func=synergy&synergyAction=showTOC&journalCode=all&volume=59&issue=1&year=2004&part=null

 COUNTRIES – EU - COSMETICS

Cosmetics Legislation Updates. The updates are available in several languages.

The Cosmetics Directive was amended, official date March 11, 2003.  The new directive text comes into force on March 11, 2005.  On this page there is a link to the new directive text. 

Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, Outcome of discussions: From this page there is a link e.g. to the PDF-file on 'perfume and aromatic raw materials' http://europa.eu.int/comm/food/fs/sc/sccp/outcome_en.html

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COUNRIES – EU – REACH (NEW CHEMICAL POLICY)

News on REACH

(Medicines and cosmetics (incl. fragrance chemicals) don't belong under the REACH)

The Commission's  proposals for the new chemical policy (REACH) have been the battleground for fierce lobbying from the chemicals industry and NGOs. The intensity of the debate was shown by the number of responses to the 8-week Internet consultation organized by the Commission. More than 6,000 contributions were received. 42 per cent of them were sent by industry. 142 NGOs participated. Five Member State governments and 10 public authorities as well as lots of important international trading partners (such as Canada, Japan, the USA and others) sent their comments and position papers.

In short: industry fears that the proposed new chemicals policy will undermine the competitiveness of the European chemicals industry and will cost many thousands of jobs. For the industry and some governments (especially the German government), the outcome of this chemicals review will determine how serious the EU is in its Lisbon ambitions to become the world's most competitive knowledge society by 2010. NGOs claim that the revision will be good for the environment and public health and see the chemicals review as the ultimate test for the sustainable development strategy of the Union.

Below we summarize some of the activities and positions.

Bush administration blasted by American NGOs

The US chemical industry and the Bush administration have also lobbied hard against the Commission's plans. The US administration stated that "the European Commission's draft chemicals regulation appears to adopt a particularly costly, burdensome, and complex approach, which could prove unworkable in its implementation, adversely impact innovation and disrupt global trade."

In a report released on 9 September, 70 health and environmental NGOs in the United States accuse their government of "intervening in the regulatory process of sovereign nations at the behest of the industry". In a letter to the Bush administration, the NGOs urge their government "to recognize the potential benefits (of REACH) to American consumers and businesses and cease all efforts to undermine EU chemicals policy reforms" and request "that the Administration solicit public comments from the American people to formulate a forward-looking position on chemicals policy to prepare for new economic realities of the 21st century".

Source: EurActiv News, September 12, 2003

German position

The German industry has opposed the REACH proposals from the start. It has asked corporate consultants Arthur D. Little for a second economic assessment of the Commission's proposals. The results of the new study indicate that the current proposals in the Commission's consultation paper would lead to a gross value added loss of 4.7 per cent. More than 1.7 million jobs would be at risk if the proposals were to become law. In its press conference in Brussels on 16 September, the German industry federation BDI called for "a new REACH", which should consist of three elements:

the new REACH should focus on the "most problematic" substances, instead of targeting all substances at the same time; communication in the supply chain between producers and users of chemical substances should be better organised; the Commission should conduct pilot projects in order to test how the major elements of its proposals would function in practice.

(Scherrmann: The German governmental agency for environment (UBA) made a study that the sight of the BDI is incorrect, but the government is hearing on BDI not at UBA)

The French government has also been warning that the Commission proposals would undermine the competitiveness of the European chemicals industry and lead to job losses

In the UK, Trade and Industry Secretary Patricia Hewitt announced on 16 September that her country is ready for a showdown with the Commission on this legislation as it would "destroy the European chemicals industry".

Environment NGOs have repeatedly questioned these economic impact assessments, accusing the industry of scaremongering over job losses and forgetting about positive effects for health and the environment. For the NGOs, the chemicals debate has also become a test case, but then on the commitments of the EU concerning its sustainable development strategy. In a reaction to the new Arthur D. Little report presented by the BDI, the Greens in the European Parliament accused the report of being "detached from economic reality". They criticised the methodology of the study.

Source: EurActiv, September 18, 2003

Main points of the revised proposal

The revised proposal drafted by the Commission demonstrates that the participants in the stakeholder consultation had a real impact on the final outcome of the future legislation. The Consultation Document from May 2003 was revised in several areas. The most important changes are the following:

Scope of the system:

Polymers have been exempted from registration, but may still be subject to authorisation and restriction; the Commission can amend this provision once sound scientific criteria have been developed to define which polymers should be registrered; The requirements for substances in articles have been watered down; The requirement to undertake chemical safety assessments has been considerably reduced;

Legal certainty

The "duty of care" provision for industry has been more clearly defined as companies feared they would be confronted with open-ended liability claims; The European Chemicals Agency (to be set up) will have a Board of Appeal;

Costs

For downstream users, the obligation to undertake chemical safety assessments and produce chemical safety reports has been strictly limited; Registration obligations for production of 1-10 tonnes have been simplified; Intermediates transported under strict control face less severe requirements;

Bureaucracy / Powers of the Agency

Streamlined legislation: the Agency will be the sole responsible;

Evaluation: the Agency has more and clearer responsibility;

The system of chemicals safety reports has been better coordinated with the existing system of safety data sheets; The Agency will have more powers as to decisions on data sharing, R&D exemptions and confidentiality;

Confidentiality

Stricter protection for sensitive and confidential business information ; all information that is non-confidential will be available on request;

Substitution

Stronger provision for substitution: companies will be encouraged to present substitution plans; this may influence decisions on authorisations;

Animal testing

No increased animal testing.

Together with the legislative proposals, the Commission will present a new impact assessment, which will, according to sources in the Commission, be more accurate than the industry studies prepared in France and Germany.

The following documents related to the revised proposal are available:

* Commission draft document: www.euractiv.com/ndbtext/environ/reach1.doc " Proposal for a Regulation concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH) - Volume I

Commission draft document: www.euractiv.com/ndbtext/environ/reach2.doc" Proposal for a Regulation concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH) - Volume II

Commission draft document: www.euractiv.com/ndbtext/environ/reach3.doc" Proposal for a Regulation concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH) - Volume III

Commission draft document: www.euractiv.com/ndbtext/environ/reach4.doc" Proposal for a Regulation concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH) - Volume IV

Commission draft document: www.euractiv.com/ndbtext/environ/reach5.doc" Proposal for a Regulation concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH) - Volume V

Commission draft document: www.euractiv.com/ndbtext/environ/reach6.doc" Proposal for a Regulation concerning the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH) - Volume VI

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Wednesday, 29 October, 2003  EU launches chemicals crackdown

Chemicals will be subject to more stringent testing

Chemicals found in many household items will be more tightly regulated, if plans put forward by the European Commission become law.

Under the draft proposals, which were published on Wednesday, companies will have to disclose basic data on all the chemicals they produce.

Around 30,000 chemicals will undergo tests to prove their safety if the proposals are enforced in 2005.

But some campaigners say the regulations do not go far enough. … http://news.bbc.co.uk/1/hi/sci/tech/3222319.stm

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BELGIUM: October 31, 2003 - EU launches controversial "user-safe" chemicals law

BRUSSELS - Hidden health risks from chemicals lurking in everything from carpets to car interiors should be spotted and stopped under controversial environmental legislation proposed by the European Commission this week.

Story by Robin Pomeroy http://www.planetark.org/dailynewsstory.cfm/newsid/22716/story.htm

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DISEASE – ALLERGY – ASTHMA

European Union meets the challenge of the growing importance of allergy and asthma in Europe http://www.blackwell-synergy.com/links/doi/10.1111/j.1398-9995.2004.00425.x/abs/

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DISEASE – BREAST  CANCER

From http://www.womensenews.org

New Front Opens in Fight Against Breast Cancer

By Molly M. Ginty - WeNews correspondent

WOMENSENEWS)-- …  Science has yet to explain why 1 in 8 U.S. women develops breast cancer, a figure that hovered at 1 in 22 back in 1940. For the past 60 years, the incidence of breast cancer has risen steadily in the United States. Researchers note that this coincides with the use of synthetic chemicals that have not been fully tested for safety. …

According to Breast Cancer Action, of the 85,000 synthetic chemicals in use today, only 7 percent have been screened for complete toxicological data. According to the Centers for Disease Control and Prevention in Atlanta, the average American carries 116 synthetic chemicals in his or her body, including dioxin, PAHs and other toxins proven to cause mammary cancer in lab animals. Tests on rats and mice have implicated 45 separate chemical compounds in breast cancer formation. But outside the lab, it is difficult to gauge how and when these chemicals affect living, breathing women. …

For more information:

The Breast Cancer Fund-- - "State of the Evidence: What is the Connection between - Chemicals and Breast Cancer?": - http://www.breastcancerfund.org/environment_evidence_main.htm

Breast Cancer Action: - http://www.bcaction.org/

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 DISEASE – MCS

Environmental Health Perspectives, Volume 111, Number 12, September 2003

Environmental Medicine Review

Stanley M. Caress1 and Anne C. Steinemann2, 1State University of West Georgia, Carrollton, Georgia, USA; 2Georgia Institute of Technology, Atlanta, Georgia, USA

A Review of a Two-Phase Population Study of Multiple Chemical Sensitivities

Abstract

In this review we summarize the findings of a two-phase study of the prevalence, symptomatology, and etiology of multiple chemical sensitivities (MCS). We also explore possible triggers, the potential linkage between MCS and other disorders, and the lifestyle alterations produced by MCS. The first phase of the study consisted of a random sampling of 1,582 individuals from the Atlanta, Georgia, metropolitan area to determine the reported prevalence of a hypersensitivity to common chemicals. In this phase, 12.6% of the sample reported a hypersensitivity. Further questioning of individuals with a hypersensitivity indicated that 13.5% (1.8% of the entire sample) reported losing their jobs because of their hypersensitivity. The second phase was a follow-up questioning of the respondents who initially reported hypersensitivity. In this phase, we found that individuals with hypersensitivity experience a variety of symptoms and triggers. A significant percentage (27.5%) reported that their hypersensitivity was initiated by an exposure to pesticides, whereas an equal percentage (27.5%) attributed it to solvents. Only 1.4% had a history of prior emotional problems, but 37.7% developed these problems after the physical symptoms emerged. This suggests that MCS has a physiologic and not a psychologic etiology. Key words: chemical injury, environmental illness, MCS, multiple chemical sensitivities, TILT, toxicant-induced loss of tolerance. Environ Health Perspect 111:1490-1497 (2003). [Online 9 April 2003]

You can read this entire article in HTML or PDF.

http://ehp.niehs.nih.gov/members/2003/5940/5940.html

http://ehp.niehs.nih.gov/docs/2003/111-12/toc.html

http://ehp.niehs.nih.gov/members/2003/5940/5940.pdf (ONLINE) (full article)

http://ehp.niehs.nih.gov/docs/2003/5940/abstract.html

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LAW

From Joseph W. Cherner

Sweden to Become World's 5th Smokefree Country

Smokefree workplace legislation happening throughout the world

Sweden, 12/17/03... Sweden's Health Minister, Morgan Johansson, announced today that Sweden will implement smokefree workplace regulations, including restaurants and bars, on July 1, 2005.  The plan has the backing of Sweden's ruling Social Democrats, the Green Party, and the Left Party.

 "Smokefree workplace laws are happening for a good reason," says Joe Cherner, founder of BREATHE-- Bar and Restaurant Employees Advocating Together for a Healthy Environment.  "Tobacco smoke causes cancer, respiratory illness, and heart disease.  No one should have to breathe it to hold a job."

Sweden will join Ireland, Norway, New Zealand, and Bhutan as the world's first smokefree workplace countries.

To send a letter of congratulations to Sweden, go to www.smokefree.net/Sweden

To send a letter of congratulations to Ireland, go to www.smokefree.net/Ireland

To send a letter of congratulations to New Zealand, go to www.smokefree.net/NZ

To send a letter of support for smokefree workplaces where YOU live, go to www.smokefree.net/alerts.php
 

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 SCIENCE

Environmental Health Perspectives is now available on-line for free (no subscription needed anymore). 

Environmental Health Perspectives is a publication of the National Institutes of Health (NIH), peer reviewed and dedicated to research on the effects of the environment on human health. http://ehp.niehs.nih.gov/docs/admin/openaccess.html  

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SCIENCE – NANOTECHNOLOGY

By Alex Kirby, BBC News Online environment correspondent
Microscopic pollutant particles given off by traffic and industry can enter the bloodstream and the brain after being inhaled, scientists have found.

The particles are known to cause lung damage in susceptible patients, and are implicated in cardiovascular disease.

Story from BBC NEWS: http://news.bbc.co.uk/go/pr/fr/-/1/hi/sci/tech/3379759.stm

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end of newslettter /English/25