1. Full citation. Vogel, David. The Politics of Precaution: Regulating Health, Safety, and Environmental Risks in Europe and the United States. Princeton [N.J.: Princeton UP, 2012. Print.
2. Where did/does the author work, what else has s/he written about, and what are her/his credentials? David Vogel is professor at the Haas School of Business and in the Department of Political Science at the University of California, Berkeley. His books include The Market for Virtue: The Potential and Limits of Corporate Social Responsibility.
3. What are the topics of the text?
This chapter compares European and American regulatory policies toward several additional non-food-related health and safety product risks, namely those posed by pharmaceuticals, and chemicals in children's toys and cosmetics
4. What is the main argument of the text?
Two of the three areas in the chapter show that the EU and the US regulations have converged, though the dynamics are different. With pharmaceuticals, the most important exception to increased transatlantic divergence is the political salience in the EU and in the US, phthalate softeners converged in EU and the US due to time lag, and in cosmetics, safety shows increased transatlantic divergence: many substances permitted in cosmetics sold in the United States are now banned in the European Union.
5. Describe at least three ways that the argument is supported.
Pharmaceuticals - Stringency of US regulation led to drug lag - in the 1960s nearly 4 times as many new medicines were introduced in GB as in the US and between 1963-1975 the drug lag was 2.1 years - Americans were upset that medicines that could save lives were being withheld from them.
Phthatlates - EU's response similar to beef hormones (public pressure led to highly stringent risk regulation), however the US case study is unusual because of the politics (Senator Feinstein's ability to persuade Congress to restrict phthalates)
Cosmetics - (successful) - firms are anxious to protect reputations and industry is highly integrated (Revlon, Unilever, and L'Oreal all conform to EU standards while Estee Lauder manufactures 95% according to one safety standard. Avon also announced plans to reforumulate to remove phthalate DBP (and did in all nail products, as have 3 other major nail polish manufacturers)
6. What three quotes capture the message of the text?
In 1986, the chairman of the CSD emphasized that "drug regulatory authorities should be immune from political and public pressure." He subsequently described the Committee's work as "concerned strictly with scientific issues," in marked contrast to the more politicized environment, owing to increased public risk awareness and pressures from Congress, in which the FDA now functioned. (p 193)
Between 1972 and 1994, the percentage of drugs removed from the market in Great Britain was four times higher than in the United States, while several drugs removed from the British market had not been approved for use in the United States. (p 194)
The US and the EU arrived at comparable policies through very different means, namely public pressures by those who wanted more drugs to be made available more quickly (US), and an interest in giving pharmaceutical firms more rapid access to a single European market in the latter (EU. (p 202)
7. What three questions about environmental risk and precaution does this article leave you with?
How are the EU and the US moving forward? What new approaches are being brought under consideration?
In what kinds of cases is public pressure more effective and in which kinds of cases are policies more effective? If two sides are arguing two different things (risk of phthalates), how do people choose which side to support?
Why was the cosmetics industry never an industry anyone thought to regulate? What NGOs or other such organizations are trying to do something about it?
8. What three points, details or references from the text did you follow up on to advance your perspective on environmental risk and precaution? (Provide citations, with a brief explanation of what you learned. One of these should be fully annotated, as your second required reading for each week.)
"Six Chemicals in Soft Plastic Toys Banned Across Europe," Environment News Service, July 6, 2005. <http://www.ens-newswire.com/ens/jul2005/2005-07-06-05.asp>
The European Parliament voted to impose a permanent ban on six chemicals used in plastic toys and childcare articles to soften the plastics. Young children can ingest the toxic chemicals when they suck or chew on the soft plastic items. Industry representatives are outraged, however, because previous testing has shown that the chemicals were below harmful standards.
"China to Ban 1,200 Substances from Cosmetics Production," Xinhua News Agency, December 19, 2006.<http://news.xinhuanet.com/english/2006-12/19/content_5507541.htm> China is expected to issue a new set of regulations at the end of this month banning more than 1,200 substances in cosmetics.
Notes
Consumer Safety - This chapter compares European and American regulatory policies toward several additional non-food-related health and safety product risks, namely those posed by pharmaceuticals, and chemicals in children's toys and cosmetics (2 of the 3 cases show that EU and US regulations have converged, though the dynamics are different). -> pharmaceuticals: most important exception to increased transatlantic divergence: distinctive is political salience (public pressures on policy makers to change how risk regulations are being made) increased in the US and not in EU so the US was brought into closer alignment than those of the EU (which were stable even after harmonized) - EU policies did affect those in the US (b/c of the drug lag) and also to expedite drug approvals. -> Phthalate softeners also converged in EU and the US (time lag)
-> cosmetics safety shows increased transatlantic divergence: many substances permitted in cosmetics sold in the United States are now banned in the European Union
Pharmaceuticals
-1960s - sedative thalidomide was taken by pregnant women for morning sickness (sold over the counter in Germany from 1957) - 1961 children were born with defects and died by their first birthday (10,000 children in EU with 4,000 in Germany were born with flippers instead of arms and legs) - only 40 in the US because it was not approved by the FDA (US responded by enacting the world's most comprehensive and stringent drug regulations)
-In the US: Legislation was first introduced to promote price competition but with the thalidomide scandal in the EU was amended to become the Pure Food and Drug Act (JFK)
-> Legislation's most important provision required manufacturers to provide "substantial evidence" that a new drug was "effective" before it could be approved (also applied retroactively to previously approved drugs, and involved the FDA). -> Before testing any drugs on humans, a firm was required to submit a drug investigation plan that included the results of animal testing as well as its plans for human tests. The FDA could then deny permission for further testing, request additional info, or modify terms for proposed plan -In the EU:
-> Germany enacted legislation requiring federal registration of all new medicines (strengthened in 1964 - but not with formal pre-market requirements until 1971). German legislation strengthened controls over manufacturing practices, clinical investigationss, and protection of human subjects but were weaker than in the US. German authorities preferred to leave improvements to industry (has the most direct interest in insuring the safety and effectiveness of its profits)
-> GB: 1963 - Voluntary Committe on the Safety of Drugs (pre-market safety reviews), 1971 required formal proof of efficacy. -> EU in 1965 established common criteria for quality, safety, and efficacy before new drug approval, but weaker than in the US. -> Through the 1980s drug manufacturers continued to seek approvals at the national level and drug regulation remained unharmonized Differences - After 1962 US had the most stringent drug requirements. More fearful of the political consequences of permitting the marketing of a drug that turned out to be unsafe, than in delaying approval of a drug that turned out to be both safe and effective, US regulatory officials demanded extensive pre-marketing testing (p 193) -> took 10 years to approve a drug -> Germany and GB used peer review
-In 1986, the chairman of the CSD emphasized that "drug regulatory authorities should be immune from political and public pressure." He subsequently described the Committee's work as "concerned strictly with scientific issues," in marked contrast to the more politicized environment, owing to increased public risk awareness and pressures from Congress, in which the FDA now functioned. (p 193) -US focused on preventing harmful effects before they occurred and EU emphasized reducing harms to public health after they occurred (yellow card schemes) - led to withdrawal of previously used drugs -> Between 1972 and 1994, the percentage of drugs removed from the market in Great Britain was four times higher than in the United States, while several drugs removed from the British market had not been approved for use in the United States. (p 194)
Stringency of US regulation led to drug lag - in the 1960s nearly 4 times as many new medicines were introduced in GB as in the US and between 1963-1975 the drug lag was 2.1 years - same as Sweden, Denmark, and Norway (strictest drug approvals in EU) - GB had fastest approval times followed by Germany
1979 - FDA accused of being overly cautions instead of insufficiently risk-averse in approving new drugs, drug lag could have saved lives
1980s - AIDS+public pressure to reform FDA policies: people wanted immediate access to drugs that might possibly prolong lives or suffering - fee to pay for more testers and faster times
1997 - user fee program was renewed in the FDA Modernization Act (FMA) - required substantial evidence of drug effectiveness, safety, and quality from just one clinical test, later 3rd party approval was also granted
-> Ironically reduction in the FDA's review time meant Americans could no longer observe how patients in European countries were responding to a new drug before deciding whether or not to approve it
EU also standardized process so there was 1 app instead of 15 with EMEA (saved money on testing, advertising, and marketing)
So while standards are roughly comparable between EU and the US, the EU also has post-monitoring drug performance after approval (5 years) - co-equal even though the US is half of all global sales (bigger than EU)
The US and the EU arrived at comparable policies through very different means, namely public pressures by those who wanted more drugs to be made available more quickly (US), and an interest in giving pharmaceutical firms more rapid access to a single European market in the latter (EU. (p 202)
Phthalates (children's products)
because they are a family of existing chemicals, they are not subject to the screening for toxicity that is required for new chemicals
cars, floor tiles, shower curtains, cosmetics, medical devices such as tubing and fluid containers, as well as products for children such as bath toys, books, rattles, teethers, bibs, dolls, and plastic figures
loose chemical bond - leach into human body through mouth or skin, where they can interfere with reproductive hormones and are suspected to be endocrine disrupters
-> EPA classified one phthalate, DEHP as a potential carcinogen in the 1980s and in 1986 under a voluntary agreement between the toy industry and the Consumer Product Safety Commission switched to DINP (no testing was done though, and it presented similar risks)
first emerged as a political issue in EU in 1997 when Danish authorities issued emergency warnings for teething rings made in China for an Italian company (firm voluntarily withdrew them to study even though it met EU safety standards)
1990s Greenpeace had a successful campaign in EU about health effects of PVC toys (cancer and reproductive abnormalites) - linked to increased skepticism about industry and gov't claims about product safety (esp after the BSE crisis)
naming and shaming campaigned by Greenpeace led to removal of soft PBC toys in many retailers - Mattel announced it would make its plastic toys out of organically based materials rather than plastics. LEGO, IKEA, and the Body Shop also went PVC free
-> studies in Europe and in Dutch and Austria and the US then showed that leaching through teething toys were too rare to be statistically modeled
Concerned about impending regulatory action in Europe, Vernon Weaver, the American Ambassador to the EU, warned the European Commission that "sudden bans on products which have been sold for years and which is based on incomplete and perhaps erroneous information could cause a trade misunderstanding between the US and the EU" (p 205)
Dec 1999 the European Comission issued a temprorary ban that was extended until becoming permanent in 2004 for no PVC (6 types) in things intended for mouth placement under 3 years - ban was criticised by European Council for Plasticizers, which blamed Greenpeace for misguiding stories and creating anxiety on the part of parents
According to a chemist - EU's ban was prompted by the politicians' desire to appear to be protecting their constituents from scientifically unproven risks -> Protests by vinyl manufacturers
Restriction was slower in the US - one phthalate (DEHP) had already been voluntarily removed and most pacifiers sold in the US were made of latex instead. In 1998 Toys R Us and McDonalds announced they would phase out after public pressure from Greenpeace
Dec 1998 DINP study concluded that amounts ingested don't even come close to a harmful level
nevertheless firms were requested (voluntary) to stop selling as a precuationary measure (intended for oral use) - only significant risk if they placed soft toys in their mouth for more than 75 mins a day (but that few children did so)
-> no regulation on internet sold items
-> China sold phthalate free items to EU but the same versions with phthalates to the US
Oct 2007 California banned phthalates on their own
In Aug 2008 - lead scare by toys from China - 45 million toys recalled (30 mil from China) - led the US to strengthen consumer safety standards (The Consumer Product Safety Act) - more risk-averse statute than the EU
ExxonMobil Chemical (major manufacturer of DINP) noted that in 2003 CPSC had determined that soft plastic toys posed no threat to children's health and that the risk of removing DINP will result in weaker or more brittle plastics that may pose a choking hazard
EU's tolerance levels for lead are essentially the same as that of the US, but EU's toy protection standard also bans 55 allergenic substances and whild hazardous substances in electronic toys are not covered by any federal regulation in the US, in EU they are restricted by the Restriction of Hazardous Substances (RoHS) directive, which applies to all electrical products
Analysis - EU's response similar to beef hormones (public pressure led to highly stringent risk regulation), however the US case study is unusual because of the politics (Senator Feinstein's ability to persuade Congress to restrict phthalates) -> Politics? Democratic party having majority of both houses? Taking advantage over led scare gave Feinstein the opportunity to include a phthalate provision in the CPSC?
Cosmetic Safety
Safety of the ingredients used in cosmetics and other personal care producs demonstrates steadily increasing European regulatory stringency after 1990 (p 211)
US: safety is the responsibility of the manufacturers. The Cosmetics Ingredients Review only assesses the safety of the more commonly used ingredients and bases its assessments on scientific journals. It has no legal authority and the FDA is not obligated to act on its findings (US has weak regulatory structure, monitoring, and enforcement) - 11% of 10,500 ingredients have been assessed for safety by CIR
EU: 1997 creates Scientific Committee on Cosmetic Products (now Consumer) - indpendent group of scientists with expertise in risk assessment - 3 major classes of toxicity (cancer, hormonal/reproductive disturbances, genetic damage) -> Negative and positive lists
Europe is the undisputed international regulatory hegemon - increase in its regulatry expertise, control over market access, stringency of standards, and size of its market for cosmetics (EU: 29% in 2006, US: 21)
In his 2007 book, Exposed, Mark Schapiro reported the results of a study conducted by a non-government organization that found that hundreds of varieties of skin and tanning lotions, nail polish, mascara, and other personal care products were being sold in the United States that contained known or possible carcinogens, mutagens, and reproductive toxins. (p 213)
According to the Campaign for Safe Cosmetics, "the FDA does not review what goes into cosmetics before they are marketed, cannot compel companies to provide data - including health effects data - and cannot recall products." The Environmental Action Working Group claims that of the more than 10,000 ingredients used in cosmetics and personal care products, 80% have never been subjected to a safety evaluation by the FDA. (p 213)
-> California made their own regulations
Faced with their inability to change federal cosmetics regulations, and inspired by the adoption of more stringent regulations by both the EU and California, the Campaign for Safe Cosmetics has attempted to pressure cosmetics firms to voluntarily adopt restrictions on their chemical ingredients
-> Success - firms are anxious to protect reputations and industry is highly integrated (Revlon, Unilever, and L'Oreal all conform to EU standards while Estee Lauder manufactures 95% according to one safety standard. Avon also announced plans to reforumulate to remove phthalate DBP (and did in all nail products, as have 3 other major nail polish manufacturers) -> be wary of unlabeled products
EU policy reform - public pressure, US - claims to have not found any credible evidence that EU banned cosmetics ingredients were unsafe, activist pressures in the US and California have affected practices of many firms (more responsive to alarm bells by activists than by the US gov't)
-> dynamics of private "trading up" have reduced the divergence between EU and US in this example
1. Full citation.
Vogel, David. The Politics of Precaution: Regulating Health, Safety, and Environmental Risks in Europe and the United States. Princeton [N.J.: Princeton UP, 2012. Print.
2. Where did/does the author work, what else has s/he written about, and what are her/his credentials?
David Vogel is professor at the Haas School of Business and in the Department of Political Science at the University of California, Berkeley. His books include The Market for Virtue: The Potential and Limits of Corporate Social Responsibility.
3. What are the topics of the text?
This chapter compares European and American regulatory policies toward several additional non-food-related health and safety product risks, namely those posed by pharmaceuticals, and chemicals in children's toys and cosmetics
4. What is the main argument of the text?
Two of the three areas in the chapter show that the EU and the US regulations have converged, though the dynamics are different. With pharmaceuticals, the most important exception to increased transatlantic divergence is the political salience in the EU and in the US, phthalate softeners converged in EU and the US due to time lag, and in cosmetics, safety shows increased transatlantic divergence: many substances permitted in cosmetics sold in the United States are now banned in the European Union.
5. Describe at least three ways that the argument is supported.
6. What three quotes capture the message of the text?
7. What three questions about environmental risk and precaution does this article leave you with?
8. What three points, details or references from the text did you follow up on to advance your perspective on environmental risk and precaution? (Provide citations, with a brief explanation of what you learned. One of these should be fully annotated, as your second required reading for each week.)
The European Parliament voted to impose a permanent ban on six chemicals used in plastic toys and childcare articles to soften the plastics. Young children can ingest the toxic chemicals when they suck or chew on the soft plastic items. Industry representatives are outraged, however, because previous testing has shown that the chemicals were below harmful standards.
Consumer organisations and NGOs are relieved with the phthalates ban, but while the toy industry points to a "misuse of the precautionary principle".
China is expected to issue a new set of regulations at the end of this month banning more than 1,200 substances in cosmetics.
Notes
Consumer Safety - This chapter compares European and American regulatory policies toward several additional non-food-related health and safety product risks, namely those posed by pharmaceuticals, and chemicals in children's toys and cosmetics (2 of the 3 cases show that EU and US regulations have converged, though the dynamics are different).
-> pharmaceuticals: most important exception to increased transatlantic divergence: distinctive is political salience (public pressures on policy makers to change how risk regulations are being made) increased in the US and not in EU so the US was brought into closer alignment than those of the EU (which were stable even after harmonized) - EU policies did affect those in the US (b/c of the drug lag) and also to expedite drug approvals.
-> Phthalate softeners also converged in EU and the US (time lag)
-> cosmetics safety shows increased transatlantic divergence: many substances permitted in cosmetics sold in the United States are now banned in the European Union
Pharmaceuticals
-1960s - sedative thalidomide was taken by pregnant women for morning sickness (sold over the counter in Germany from 1957) - 1961 children were born with defects and died by their first birthday (10,000 children in EU with 4,000 in Germany were born with flippers instead of arms and legs) - only 40 in the US because it was not approved by the FDA (US responded by enacting the world's most comprehensive and stringent drug regulations)
-In the US: Legislation was first introduced to promote price competition but with the thalidomide scandal in the EU was amended to become the Pure Food and Drug Act (JFK)
-> Legislation's most important provision required manufacturers to provide "substantial evidence" that a new drug was "effective" before it could be approved (also applied retroactively to previously approved drugs, and involved the FDA).
-> Before testing any drugs on humans, a firm was required to submit a drug investigation plan that included the results of animal testing as well as its plans for human tests. The FDA could then deny permission for further testing, request additional info, or modify terms for proposed plan
-In the EU:
-> Germany enacted legislation requiring federal registration of all new medicines (strengthened in 1964 - but not with formal pre-market requirements until 1971). German legislation strengthened controls over manufacturing practices, clinical investigationss, and protection of human subjects but were weaker than in the US. German authorities preferred to leave improvements to industry (has the most direct interest in insuring the safety and effectiveness of its profits)
-> GB: 1963 - Voluntary Committe on the Safety of Drugs (pre-market safety reviews), 1971 required formal proof of efficacy.
-> EU in 1965 established common criteria for quality, safety, and efficacy before new drug approval, but weaker than in the US.
-> Through the 1980s drug manufacturers continued to seek approvals at the national level and drug regulation remained unharmonized
Differences - After 1962 US had the most stringent drug requirements. More fearful of the political consequences of permitting the marketing of a drug that turned out to be unsafe, than in delaying approval of a drug that turned out to be both safe and effective, US regulatory officials demanded extensive pre-marketing testing (p 193) -> took 10 years to approve a drug
-> Germany and GB used peer review
-In 1986, the chairman of the CSD emphasized that "drug regulatory authorities should be immune from political and public pressure." He subsequently described the Committee's work as "concerned strictly with scientific issues," in marked contrast to the more politicized environment, owing to increased public risk awareness and pressures from Congress, in which the FDA now functioned. (p 193)
-US focused on preventing harmful effects before they occurred and EU emphasized reducing harms to public health after they occurred (yellow card schemes) - led to withdrawal of previously used drugs
-> Between 1972 and 1994, the percentage of drugs removed from the market in Great Britain was four times higher than in the United States, while several drugs removed from the British market had not been approved for use in the United States. (p 194)
Stringency of US regulation led to drug lag - in the 1960s nearly 4 times as many new medicines were introduced in GB as in the US and between 1963-1975 the drug lag was 2.1 years - same as Sweden, Denmark, and Norway (strictest drug approvals in EU) - GB had fastest approval times followed by Germany
1979 - FDA accused of being overly cautions instead of insufficiently risk-averse in approving new drugs, drug lag could have saved lives
1980s - AIDS+public pressure to reform FDA policies: people wanted immediate access to drugs that might possibly prolong lives or suffering - fee to pay for more testers and faster times
1997 - user fee program was renewed in the FDA Modernization Act (FMA) - required substantial evidence of drug effectiveness, safety, and quality from just one clinical test, later 3rd party approval was also granted
-> Ironically reduction in the FDA's review time meant Americans could no longer observe how patients in European countries were responding to a new drug before deciding whether or not to approve it
EU also standardized process so there was 1 app instead of 15 with EMEA (saved money on testing, advertising, and marketing)
So while standards are roughly comparable between EU and the US, the EU also has post-monitoring drug performance after approval (5 years) - co-equal even though the US is half of all global sales (bigger than EU)
The US and the EU arrived at comparable policies through very different means, namely public pressures by those who wanted more drugs to be made available more quickly (US), and an interest in giving pharmaceutical firms more rapid access to a single European market in the latter (EU. (p 202)
Phthalates (children's products)
because they are a family of existing chemicals, they are not subject to the screening for toxicity that is required for new chemicals
cars, floor tiles, shower curtains, cosmetics, medical devices such as tubing and fluid containers, as well as products for children such as bath toys, books, rattles, teethers, bibs, dolls, and plastic figures
loose chemical bond - leach into human body through mouth or skin, where they can interfere with reproductive hormones and are suspected to be endocrine disrupters
-> EPA classified one phthalate, DEHP as a potential carcinogen in the 1980s and in 1986 under a voluntary agreement between the toy industry and the Consumer Product Safety Commission switched to DINP (no testing was done though, and it presented similar risks)
first emerged as a political issue in EU in 1997 when Danish authorities issued emergency warnings for teething rings made in China for an Italian company (firm voluntarily withdrew them to study even though it met EU safety standards)
1990s Greenpeace had a successful campaign in EU about health effects of PVC toys (cancer and reproductive abnormalites) - linked to increased skepticism about industry and gov't claims about product safety (esp after the BSE crisis)
naming and shaming campaigned by Greenpeace led to removal of soft PBC toys in many retailers - Mattel announced it would make its plastic toys out of organically based materials rather than plastics. LEGO, IKEA, and the Body Shop also went PVC free
-> studies in Europe and in Dutch and Austria and the US then showed that leaching through teething toys were too rare to be statistically modeled
Concerned about impending regulatory action in Europe, Vernon Weaver, the American Ambassador to the EU, warned the European Commission that "sudden bans on products which have been sold for years and which is based on incomplete and perhaps erroneous information could cause a trade misunderstanding between the US and the EU" (p 205)
Dec 1999 the European Comission issued a temprorary ban that was extended until becoming permanent in 2004 for no PVC (6 types) in things intended for mouth placement under 3 years - ban was criticised by European Council for Plasticizers, which blamed Greenpeace for misguiding stories and creating anxiety on the part of parents
According to a chemist - EU's ban was prompted by the politicians' desire to appear to be protecting their constituents from scientifically unproven risks -> Protests by vinyl manufacturers
Restriction was slower in the US - one phthalate (DEHP) had already been voluntarily removed and most pacifiers sold in the US were made of latex instead. In 1998 Toys R Us and McDonalds announced they would phase out after public pressure from Greenpeace
Dec 1998 DINP study concluded that amounts ingested don't even come close to a harmful level
nevertheless firms were requested (voluntary) to stop selling as a precuationary measure (intended for oral use) - only significant risk if they placed soft toys in their mouth for more than 75 mins a day (but that few children did so)
-> no regulation on internet sold items
-> China sold phthalate free items to EU but the same versions with phthalates to the US
Oct 2007 California banned phthalates on their own
In Aug 2008 - lead scare by toys from China - 45 million toys recalled (30 mil from China) - led the US to strengthen consumer safety standards (The Consumer Product Safety Act) - more risk-averse statute than the EU
ExxonMobil Chemical (major manufacturer of DINP) noted that in 2003 CPSC had determined that soft plastic toys posed no threat to children's health and that the risk of removing DINP will result in weaker or more brittle plastics that may pose a choking hazard
EU's tolerance levels for lead are essentially the same as that of the US, but EU's toy protection standard also bans 55 allergenic substances and whild hazardous substances in electronic toys are not covered by any federal regulation in the US, in EU they are restricted by the Restriction of Hazardous Substances (RoHS) directive, which applies to all electrical products
Analysis - EU's response similar to beef hormones (public pressure led to highly stringent risk regulation), however the US case study is unusual because of the politics (Senator Feinstein's ability to persuade Congress to restrict phthalates)
-> Politics? Democratic party having majority of both houses? Taking advantage over led scare gave Feinstein the opportunity to include a phthalate provision in the CPSC?
Cosmetic Safety
Safety of the ingredients used in cosmetics and other personal care producs demonstrates steadily increasing European regulatory stringency after 1990 (p 211)
US: safety is the responsibility of the manufacturers. The Cosmetics Ingredients Review only assesses the safety of the more commonly used ingredients and bases its assessments on scientific journals. It has no legal authority and the FDA is not obligated to act on its findings (US has weak regulatory structure, monitoring, and enforcement) - 11% of 10,500 ingredients have been assessed for safety by CIR
EU: 1997 creates Scientific Committee on Cosmetic Products (now Consumer) - indpendent group of scientists with expertise in risk assessment - 3 major classes of toxicity (cancer, hormonal/reproductive disturbances, genetic damage)
-> Negative and positive lists
Europe is the undisputed international regulatory hegemon - increase in its regulatry expertise, control over market access, stringency of standards, and size of its market for cosmetics (EU: 29% in 2006, US: 21)
In his 2007 book, Exposed, Mark Schapiro reported the results of a study conducted by a non-government organization that found that hundreds of varieties of skin and tanning lotions, nail polish, mascara, and other personal care products were being sold in the United States that contained known or possible carcinogens, mutagens, and reproductive toxins. (p 213)
According to the Campaign for Safe Cosmetics, "the FDA does not review what goes into cosmetics before they are marketed, cannot compel companies to provide data - including health effects data - and cannot recall products." The Environmental Action Working Group claims that of the more than 10,000 ingredients used in cosmetics and personal care products, 80% have never been subjected to a safety evaluation by the FDA. (p 213)
-> California made their own regulations
Faced with their inability to change federal cosmetics regulations, and inspired by the adoption of more stringent regulations by both the EU and California, the Campaign for Safe Cosmetics has attempted to pressure cosmetics firms to voluntarily adopt restrictions on their chemical ingredients
-> Success - firms are anxious to protect reputations and industry is highly integrated (Revlon, Unilever, and L'Oreal all conform to EU standards while Estee Lauder manufactures 95% according to one safety standard. Avon also announced plans to reforumulate to remove phthalate DBP (and did in all nail products, as have 3 other major nail polish manufacturers)
-> be wary of unlabeled products
EU policy reform - public pressure, US - claims to have not found any credible evidence that EU banned cosmetics ingredients were unsafe, activist pressures in the US and California have affected practices of many firms (more responsive to alarm bells by activists than by the US gov't)
-> dynamics of private "trading up" have reduced the divergence between EU and US in this example