Today we are remembering the men and women of the United States military who paid the ultimate price for our great nation.

To the brave men and women who served our great country with honor and courage, may you rest in peace, for you are not forgotten!

In this article, I will examine the highly-vaunted “Precautionary Principle” (PP) so often invoked in discussions on the safety of cosmetics. The basis of this principal seems to be that, if there is any doubt over the safety of a substance, it should be banned – period. If this is not the actual basis of the principal, it is certainly the basis on which it is being evoked in the discussions in which I have been involved. I believe that there are several issues with this type of thinking, and some important questions should be raised:

1)      What are the causes of the doubts over the safety?

• Are the doubts raised as a result of sound scientific studies?

• Are they due to misinterpretation of sound scientific studies?

• Are the studies that form the basis for concern sound in the first place?

2)      Who actually doubts the safety – scientists or lobby groups?

• Do the lobby groups have sufficient evidence for doubt – to the extent that a ban could be justified?

• Do the scientists have any vested interest in sowing the seeds of doubt (i.e. gaining funding for more work on the substance in question)?

3)      Has the relationship between the hazard identified and the potential human exposure been fully assessed?

• Does the Precautionary Principle allow for any type of risk assessment?

These are all important considerations, because it is very difficult to know where to draw the line in terms of assessing a substance as being “dangerous”, or “unsafe”. What may be unsafe in one application may be perfectly safe in another. It is becoming something of a cliché, but water can be a dangerous substance – there are many documented cases of long-distance athletes dying from drinking excessive quantities.

Should we invoke the PP in the case of water? Clearly, the answer is “no”, but where should the line be drawn? How much anecdotal evidence should be required before a substance should be banned in the absence of firm scientific evidence? Salt (sodium chloride) has clearly been shown to be linked to high blood pressure, yet low doses are essential to survival. Who makes the decision on the risk/benefit calculation?

In 1996, the legendary toxicologist, Professor Bruce Ames (as in the Ames Test for mutagenicity) made the following statement:

Of the 1000 natural chemicals in a cup of coffee, 28 have been tested for carcinogenicity [in rodents] and 19 of them came out positive.

At least 19 carcinogens (possibly more have been identified in the subsequent 16 years since that statement was made) would appear to present a very strong case for invoking The Precautionary Principle, but I am not aware of any of the lobby groups calling for coffee to be banned.

A study conducted by the University of Heidelberg in Germany and the University of Milan indicates that just one alcoholic drink per day can increase a woman’s risk of developing breast cancer by 5%. Those women who are heavy drinkers, consuming three or more drinks each day, increase their risk of the disease by up to 50%. It is believed that alcohol affects oestrogen levels, which can trigger certain forms of breast cancer. Although the link between alcohol and breast cancer is already known, until now it has been unclear whether there was an increased risk with low levels of consumption or a ‘safe’ threshold, below which there was no effect on breast cancer. The full findings are published in the journal Alcohol and Alcoholism. The link between alcohol consumption and breast cancer is well-established and yet, again, the groups who take such a keen interest in consumer health are not calling for alcohol to be banned.

From The Ecologist:

Dangerous dining?
But the most controversial part of the soya debate is that surrounding its impact on human health. The main reason for concern is the isoflavones, a type of phyto-oestrogen, present in significant quantities in soya. According to Kate Arthur, a spokesperson for the British Dietetic Association (BDA), the issue is that these phyto-oestrogens are often confused with human oestrogen. ‘There have been studies done on soya isoflavones, or plant oestrogens, and fertility but all those studies have been on animals or in test tubes,’ she explains. ‘All the human data out there suggests that soya is safe to consume.’  Dr Kaayla Daniel, nutritionist and author of The Whole Soy Story is more concerned. ‘Thousands of studies link soy to malnutrition, digestive distress, thyroid problems, cognitive decline, reproductive disorders, immune system breakdown, even heart disease and cancer,’ she argues. ‘Possible benefits are far outweighed by proven risks.’ The Vegan Society’s Amanda Baker says that soya needs to be looked at in a more level-headed way. ‘What we do know is that soya is a good source of protein and including a moderate amount of soya protein can help to reduce cholesterol levels,’ she comments. ‘Really, other claims both positive and negative are almost entirely controversial – they’re not proven.’

In 2003, the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment released a report identifying three groups of people who, evidence suggested, were potentially at risk. These were infants fed on soy-based formula, people with hypothyroidism and women with breast cancer. With babies, the fear is that the high levels of isoflavones may affect development. The BDA says soya is fine from the age of six months but before that, breast milk is best. Arthur also says soya is a good option for those avoiding dairy as it contains amino acids and is often fortified with things like calcium and vitamin D. The Department of Health agrees but says breast milk it better up to a year old and that people should speak to their GP about alternatives.

For the full article, see ‘The dark side of soya: how one super crop lost its way‘

The fact that there is controversy over soy suggests that human consumption should be banned, according to the Precautionary Principle.

On a lighter note, there is surely an argument to ban babies – their breath contains measurable levels of formaldehyde – a known carcinogen: ‘Toxic Baby Alert‘

So the question seems to be:

“Why are some materials a target for the Precautionary Principle, whereas others (coffee, alcohol, soy, babies) appear to be immune from attack”?

This is totally inconsistent, especially when the link to dangers are much stronger (for alcohol especially) than for many of the cosmetic ingredients under attack.

The real issue seems to be one of bias. If something is a “chemical” (i.e. a synthetic substance) then it is acceptable to invoke the Precautionary Principle, but if the material occurs “naturally” (coffee, soy, etc.), then the PP doesn’t matter. The basic problem appears to be an attack of chemophobia – it’s as simple as that! The Precautionary Principle is a weapon used/misused to promote the agenda of those who believe all/most synthetic chemicals are bad. It should be ignored and decisions on the banning of ANY substance should be taken on the basis of sound science; not on the ill-informed speculation of those with an agenda who neither consider nor understand the science.

2 years ago today, Kristin and I launched Personal Care Truth. It’s been a fast flying 2 years, full of truthful information about personal care products and cosmetics, based on scientific facts. Our experts have provided a plethora of useful information to our readers and there have been lively discussions.

Kristin and I would like to thank you for your support of our efforts to bringing truth to the cosmetic industry. Without you, Personal Care Truth would not have survived!!! Kristin and I continue to fund PCT with personal money and greatly appreciate donations from people who support our efforts.

We look forward to what the future brings and hope you will continue to support and contribute to the dialogue. We are still over the moon excited at the response we continue to receive.

Thank you bunches!!

Image via ‘I do” it yourself

Selling personal care products in the European market is about to become quite a bit more challenging for manufacturers across the globe, especially if they are located outside the EU. In a little over 1 year, the new European Cosmetic Regulation, EC 1223/2009, will go into force on July 11, 2013, requiring all manufacturers selling any product in the 27 countries that make up the European Union to follow a new set of guidelines if they want to keep their products on the EU shelves…

I had the pleasure of meeting and interviewing Doram Elkayam, COO of Obelis, at The In-Cosmetics conference in Barcelona last week. Doram explained the intricacies of how his company acts as the Responsible Person for cosmetics manufacturers around the globe. Doram outlined that in order to be in compliance and keep your products on EU shelves come July 2013, you must meet the mandatory requirement to complete a Pre-Market Notification of a Cosmetic product. This entails:

• Pre-market notification must be completed and filed by a designated Responsible Person (RP), who is located in the EU, for each and every product you make. This includes scent variations of a product.
• For example, if you make 4 scents of body lotion using the same base formula, each of the 4 scent variations must be registered individually.
• The Responsible Person is a mandatory requirement and must be listed at the address (located within the EU) specified on the label.
• The RP must be valid for 10 years after the last batch was put on the market.

The RP’s main duty is to ensure compliance with the requirements of the European Cosmetic Regulation and hold the evidence of compliance, the Product Information File (PIF), for each product, readily available for inspection by the Authorities. The PIF includes but is not limited to:

• product description & categories
• Safety Report: information & assessment
• Method on Manufacturing including statement of compliance with GMP outlined by Coplia or Council of Europe Guidelines
• the exact formula for the product: both quantitative and qualitative composition
• data on animal testing, batch & micro testing
• data on serious undesirable effects
• label info and labeling claims (Doram pointed out that 99% of problems start with the label….)

• The PIF, while being a “live document” requiring constant care and update, lasts for the life of the product, as long as the product is not changed.

The Responsible Person, as the official “Cosmetovigilance” contact point in Europe also:

• should take immediate corrective measures in the case of non-conformity- withdrawal/recall if appropriate
• should provide the requested information and documentation to demonstrate conformity as per requests by competent & national authorities.
• Should ensure communication & dissemination of information between all the economic operators (manufacturer, importer, distributors, producers, raw material suppliers, authorities and users);
• should keep the PIF readily accessible to the CA for 10 years after the last batch was placed on the market.

The new portal that will house this info in the EU has already “opened its doors” as of January 11, 2012. Companies have just over 1 year (until July 11, 2013) to notify what products they currently have on the market in the portal and to designate and comply with the Responsible Person requirements and PIFs. Companies located within the EU can appoint someone within the company or act as their own RP, but those located outside Europe will have to comply with appointing a RP located in the European Union if they want to continue selling products on EU shelves.

Doram helped clarify many areas I was either unsure or unaware of when it comes to the new regulation requirements for manufacturers. Like Personal Care Truth, Obelis believes strongly in education. Obelis focuses on their job of educating clients on how to comply and what they need to do to keep their products on the shelves in Europe. You will find Obelis listed under our European Union Resources in the “resources” tab above or you can visit their site to learn more.

In the 4th and final post in the Spotlight on Sun Protection series, we’ll take a look at Australia, New Zealand & India and wrap up with some final thoughts on this series and manufacturing sunscreens. If you’ve just discovered the spotlight on sun protection series, you can click the links to take a look at part 1, where we covered sunscreen regulations in the USA, part 2: the EU and part 3: Asia. Australia and India were presented by Alain Khaiat, Ph.D. of Seers Consulting during a very informative half day scientific seminar I attended at In-Cosmetics Barcelona. Australia and India both have rigidly outlined stability data requirements when compared to other regions of the world, most likely due to the fact that both areas of the world can experience extreme heat.

Australia has a maximum SPF rating of 30+. There are 2 different classifications for sunscreens depending on the SPF rating. If the sunscreen has an SPF less than 15, it is considered a cosmetic; if it’s greater than 15, it’s listed as a medicine. The registration lead time is 1 month and requires the complete formulation and manufacture process, which must be conducted in a TGA approved site that has GMP (good manufacturing practice) pre-clearance. While the lead time is only a month, Australia requires a very specific stability testing report be completed first. The report needs to show the product is stable for anywhere from 6 months to a 3-year shelf life, and has rigid requirements as to the temperatures the sunscreen must be exposed to for the shelf life claim. Any accelerated testing the formulator uses for this specific data must also be confirmed by real-time testing. Since all data is required for submission to complete the 1 month registration process, the manufacturer needed to begin collecting the data over 3 years prior in order to obtain a 3 year shelf life rating. The manufacturer does not need to provide a product sample unless it’s requested, but must submit final packaging along with any proprietary ingredients (this usually means the fragrance) which also need to be registered with TGA. A separate SPF certificate is also required.

You may recall that we discussed Hong Kong’s lack of requirements in part 3… Like Honk Kong, New Zealand does not have a registration or notification process for bringing sunscreen to market. There is also no limit on the SPF factor that can be claimed on the label. So if you happen to find an SPF of 70 over there, it does not mean it’s any more powerful than the SPF 30+ you may have picked up in Australia, it’s solely the labeling claims that the country is allowed to print by law.

In India, sunscreen is considered a cosmetic and there is no maximum SPF rating. India has different registration lead times for sunscreens depending on if the product is made locally (3 months), or for import (9 months). India requires the manufacturer to release the full product formulation, including the quantitative formula with declaration and disclosure of functions of ingredients. All label text must be disclosed during the registration process along with the product specs, manufacturing process, chemical and microbiological testing methods and any data supporting product claims. India requires the manufacture to run a minimum of 2 pilot batches before registering a sunscreen. India requires specific stability testing requirements to show shelf life of the sunscreen. Testing may be done using accelerated methods of exposure to extreme heat. However, any data that is accelerated also needs to be confirmed by real time testing, so the process takes longer than the 3 or 9 months since the real time data (for up to a 3 year shelf life) needs to be available to register.

If you’ve followed this 4-part series, you’ll see that while there is no global harmonization in sunscreen or SPF ratings the different areas of the world do have one thing in common… It’s a very expensive, involved and a time consuming process to bring a sunscreen to market! As the owner of a small cosmetic company located in sunny Southern California that manufactures products, we are often asked why we don’t make sunscreen. The answer is simple; small and indie manufacturers simply cannot afford to manufacture their own sunscreen. The only way for a small or indie manufacturer could sell a sunscreen under their brand name is through a private label process where a registered lab has gone through what I’ve outlined in the past 4 posts (depending on the region of the world) and is manufacturing the sunscreen for their brand. You should be able to decipher this by looking at the “manufacturer information” on the product label which is required in most regions of the world. Hopefully this series has enlightened you a bit when it comes to sunscreens… remember, the higher the SPF # rating does not always mean the “better” sunscreen; there are so many factors due to consider the different laws and lack of continuity across the globe.

Rep Lance, Leonard [NJ-7] , introduced on 4/18/2012, H.R. 4395 To amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the registration of cosmetic product manufacturing establishments, the submission of cosmetic product and ingredient statements, and the reporting of serious and unexpected cosmetic product adverse events, and for other purposes. The bill reads as follows:

HR 4395 IH

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE AND REFERENCES.

(a) Short Title- This Act may be cited as the `Cosmetic Safety Amendments Act of 2012′.

(b) References to the Federal Food, Drug, and Cosmetic Act- Except as otherwise specified, whenever in this Act an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

SEC. 2. TABLE OF CONTENTS.

Sec. 1. Short title and references.

Sec. 2. Table of contents.

Sec. 3. Registration of cosmetic manufacturing establishments.

Sec. 4. Cosmetic and ingredient statement.

Sec. 5. Serious and unexpected adverse event reporting for cosmetics.

Sec. 6. Good manufacturing practice for cosmetics.

Sec. 7. Tolerances for nonfunctional constituents in cosmetics.

Sec. 8. Cosmetic ingredient review.

Sec. 9. Cosmetic ingredient safety.

Sec. 10. National cosmetic regulatory databank.

Sec. 11. Cosmetic records inspection.

Sec. 12. Rules of construction.

Sec. 13. Conforming amendments.

Sec. 14. National uniformity for cosmetics.

Sec. 15. Importation.

Sec. 16. Authorization of appropriations.

Sec. 17. Effective dates.

SEC. 3. REGISTRATION OF COSMETIC MANUFACTURING ESTABLISHMENTS.

Chapter VI is amended by adding at the end the following:

`SEC. 604. REGISTRATION OF COSMETIC MANUFACTURING ESTABLISHMENTS.

`(a) In General-

`(1) The Secretary shall by regulation require that every domestic and foreign establishment engaged in the manufacture of a cosmetic intended to be marketed in the United States be registered with the Secretary within 60 days after beginning such manufacture. If a cosmetic is processed in more than one establishment, registration shall be required only for the establishment that performs the final portion of the manufacturing operation. The registration shall state the name of the company or other organization, the city, street address, State, and country of the establishment, and the title, email address, and telephone number for the office within the establishment that is responsible for submitting and maintaining the registration.

`(2) The Secretary shall establish and provide to the registrant a unique cosmetic establishment registration number within 15 business days after receiving the registration. Where more than one person registers the same manufacturing establishment, the Secretary shall provide only one unique establishment registration number for the establishment.

`(b) Maintenance- The information required in a registration under subsection (a) or in an existing registration under subsection (e) shall be maintained as current and accurate by the registrant by withdrawing or amending the registration within 60 days after the information becomes no longer current and accurate.

`(c) List- The Secretary shall compile and maintain an up-to-date and publicly available electronic list of establishments that are registered under this section.

`(d) Definitions- For purposes of this chapter the following definitions apply:

`(1) The term `establishment’ is a place of business where a cosmetic is manufactured, without further processing outside or within the United States.

`(2)(A) The term `domestic establishment’ means an establishment location in any State.

`(B) The term `foreign establishment’ means an establishment location outside the States from which a cosmetic is exported to the United States.

`(3) A cosmetic shall not be considered to have undergone further processing for purposes of paragraph (1) solely on the basis that packaging or other labeling was added or that any similar activity of a de minimis nature was carried out with respect to the cosmetic.

`(e) Exemptions- Registration under subsection (a) shall not be required for any establishment that as of the date of enactment of this section is registered as a cosmetic establishment under part 710 of title 21, Code of Federal Regulations.

`(f) Suspension of Registration-

`(1) IN GENERAL- The Secretary may suspend the registration of any facility under this section for a violation of this Act that presents a significant risk of serious adverse health consequences or death to humans.

`(2) NOTICE OF SUSPENSION- Suspension of a registration under this section shall be preceded by–

`(A) notice to the establishment of the intent to suspend the registration; and

`(B) an opportunity for an informal hearing concerning the suspension.

`(3) REINSTATEMENT- A registration that is suspended under this section may be reinstated by the Secretary.

`(4) PROCEDURES- The Secretary shall by regulations establish procedures for the implementation of this subsection.

`(g) Cancellation of Registration-

`(1) IN GENERAL- Not earlier than 10 days after providing notice under paragraph (2), the Secretary may cancel a registration under this section if the Secretary determines that the registration was not updated in accordance with this section or otherwise is not current and accurate.

`(2) NOTICE OF CANCELLATION- Cancellation shall be preceded by notice to the establishment of the intent to cancel the registration and the basis for such cancellation.

`(3) TIMELY UPDATE OR CORRECTION- If the registration for the establishment is updated or corrected no later than 7 days after notice is provided under paragraph (2), the Secretary shall not cancel the registration.’.

SEC. 4. COSMETIC AND INGREDIENT STATEMENT.

Chapter VI, as amended by section 3, is amended by adding at the end the following:

`SEC. 605. COSMETIC AND INGREDIENT STATEMENT.

`(a) In General- The Secretary shall by regulation require that every domestic and foreign establishment engaged in the manufacture of a cosmetic intended to be marketed in the United States submit to the Secretary, for each cosmetic manufactured in the establishment, within 60 days after beginning manufacture of the product, a cosmetic and ingredient statement containing–

`(1) the unique establishment registration number of the manufacturing establishment where the cosmetic is manufactured or, if the same cosmetic product is manufactured in more than one establishment, the unique establishment registration number of each establishment where it is manufactured;

`(2) the brand name or names for the cosmetic;

`(3) the applicable cosmetic category or categories for the cosmetic;

`(4) the ingredients in the cosmetic (in accordance with section 701.3 of title 21, Code of Federal Regulations, and using the name of each ingredient established under subsection (b), if any), in descending order of predominance by weight, except that–

`(A) flavors and fragrances may be designated as such; and

`(B) all variations in color, flavor, or fragrance may be included in one statement; and

`(5) the title, email address, and telephone number for the office within the establishment that is responsible for filing and maintaining the statement.

The Secretary shall establish and provide to the person submitting the statement a unique cosmetic and ingredient statement number within 15 business days after receiving the statement.

`(b) Name of Ingredient- For purposes of this section and cosmetic ingredient labeling under section 701.3 of title 21, Code of Federal Regulations, the name of a cosmetic ingredient shall be the name, if any, in the most recent edition of the International Cosmetic Ingredient Dictionary, unless the Secretary, after public notice and an opportunity for public comment, by regulation or guidance establishes a different name for the ingredient.

`(c) Maintenance- The information required in a statement submitted to the Secretary under subsection (a) or in an existing statement under subsection (e)(1) shall be maintained as current and accurate by the person who filed the statement by withdrawing or amending the statement within 60 days after the information becomes no longer current and accurate, except that no amendment shall be required for a change in the order of predominance of the ingredients or for any other type or category of change for which the Secretary determines that the costs of amending the statement exceed the benefits.

`(d) List- The Secretary shall compile and maintain an up-to-date and publicly available electronic list of cosmetics and ingredients for which statements are submitted under this section. A statement submitted pursuant to this section shall not be subject to disclosure under section 552 of title 5, United States Code. The Secretary may make publicly available information derived from such statements that discloses the names of ingredients used in cosmetic products and the number of cosmetic products in which a specific ingredient is used but may not make publicly available any information that relates to any ingredient that is exempt from public disclosure under section 720.8 of title 21, Code of Federal Regulations, or that discloses at what establishment a cosmetic is manufactured. At the request of the director of a State agency responsible for regulating the safety of cosmetics, the Secretary may disclose to such official confidential business and trade secret information contained in a statement and such official and other State employees who have access to such information shall then be subject to the provisions of section 301(j), subsection 552(b) of title 5, United States Code, and section 1905 of title 18, United States Code, with respect to such information.

`(e) Exemptions- Submission of a statement under subsection (a) shall not be required for–

`(1) a cosmetic for which as of the date of enactment of this section a cosmetic ingredient statement has been submitted to the Secretary under part 710 of title 21, Code of Federal Regulations; or

`(2) a cosmetic ingredient exempt from public disclosure under section 720.8 of title 21, Code of Federal Regulations.’.

SEC. 5. SERIOUS AND UNEXPECTED ADVERSE EVENT REPORTING FOR COSMETICS.

Chapter VI, as amended by sections 3 and 4, is amended by adding at the end the following:

`SEC. 606. SERIOUS AND UNEXPECTED ADVERSE EVENT REPORTING FOR COSMETICS.

`(a) In General- The Secretary shall by regulation require that a domestic or foreign manufacturer, packer, or distributor whose name appears on the label pursuant to section 602(b)(1) of a cosmetic marketed in the United States submit to the Secretary under subsection (b) a report containing information received concerning a serious and unexpected adverse event in the United States allegedly associated with the use of the product.

`(b) Submission of Reports- A serious and unexpected adverse event report shall be submitted to the Secretary no later than 15 business days after information concerning the adverse event is received at the place of business labeled on the product under section 602(b)(1).

`(c) Contents- No such report shall be submitted unless the person submitting the report has been able to verify–

`(1) an identifiable patient;

`(2) an identifiable reporter;

`(3) a suspect cosmetic product; and

`(4) a serious and unexpected adverse event.

The person submitting the report may include in the submission any additional pertinent information and may supplement the report with additional information at a later time.

`(d) Definitions-

`(1) A `serious’ adverse event is one that–

`(A) results in–

`(i) death;

`(ii) a life-threatening experience;

`(iii) inpatient hospitalization;

`(iv) a persistent and significant disability or incapacity; or

`(v) congenital anomaly or birth defect; or

`(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).

`(2) An `unexpected’ adverse event is one that is not identified in the current labeling for the cosmetic.

`(e) Rules of Construction-

`(1) A serious and unexpected adverse event report (including all information submitted in the initial report or added later) submitted to the Secretary under subsection (a) is–

`(A) a safety report under section 756 that is subject to the provisions of that section;

`(B)(i) a record about an individual under section 552a of title 5, United States Code; and

`(ii) a medical or similar file the disclosure of which would constitute a violation of section 552(b)(6) of such title 5, and shall not be publicly disclosed.

`(2) The submission of a serious and unexpected adverse event report in compliance with subsection (a) shall not constitute an admission that the cosmetic involved caused or contributed to the adverse event.

`(f) The label of a cosmetic shall bear the domestic telephone number through which the person whose name and place of business appear on the label may receive a report of a serious and unexpected adverse event.’.

SEC. 6. GOOD MANUFACTURING PRACTICE FOR COSMETICS.

Chapter VI, as amended by sections 3, 4, and 5, is amended by adding at the end the following:

`SEC. 607. GOOD MANUFACTURING PRACTICES FOR COSMETICS.

`The Secretary shall, after public notice and an opportunity for public comment, by regulation establish good manufacturing practices for the methods used in, or the facilities or controls used for, the manufacture, processing, filling, or packaging of cosmetics. In issuing such regulations or guidance, the Secretary shall review international standards for cosmetic good manufacturing practices to ensure that such regulations or guidance are consistent, to the extent the Secretary determines practicable and appropriate, with such standards.’.

SEC. 7. TOLERANCES FOR NONFUNCTIONAL CONSTITUENTS IN COSMETICS.

Chapter VI, as amended by sections 3, 4, 5, and 6, is amended by adding at the end the following:

`SEC. 608. TOLERANCES FOR NONFUNCTIONAL CONSTITUENTS IN COSMETICS.

`(a) In General- The Secretary may on the Secretary’s own initiative, and shall in response to a petition submitted by an interested person, including a State, under subsection (b) or in accordance with the provisions under subsection (c), after public notice and an opportunity for public comment, establish by regulation or guidance a tolerance level for a nonfunctional constituent in cosmetics. For purposes of this section, a `nonfunctional constituent’ in a cosmetic is any substance that is an ancillary part of an ingredient or the manufacturing process, has not been added as a separate substance, and serves no cosmetic function in the cosmetic. The Secretary shall establish such a tolerance at a level that is necessary for the protection of the public health using generally recognized principles of scientific risk assessment. In issuing such a regulation or guidance, the Secretary shall take into consideration the level that is reasonably achievable through good manufacturing practices and shall review tolerance levels for such nonfunctional constituent established by authoritative scientific or regulatory organizations to ensure that such regulation or guidance is consistent, to the extent the Secretary determines practicable and appropriate, with such other tolerance levels.

`(b) Procedure-

`(1)(A)(i) If the review of a nonfunctional constituent is being conducted on the Secretary’s own initiative or under subsection (c), the Secretary shall initiate the proceeding by publishing in the Federal Register a proposed regulation or guidance. The Secretary shall provide 180 days for public comment.

`(ii) Not later than 180 days after the end of the period for public comment, the Secretary shall publish in the Federal Register a final regulation or guidance.

`(B)(i) If the review of a nonfunctional constituent is being conducted in response to a petition submitted by an interested person, the Secretary shall publish the petition in the Federal Register for public comment not later than 60 days after receipt of the petition. All appendices to the petition shall be made available on the Secretary’s website. The Secretary shall provide 180 days for public comment.

`(ii) Any such petition shall specify the nonfunctional constituent, the proposed tolerance level, and the scientific data and information on which the proposed tolerance level is based.

`(iii) Not later than 180 days after the end of the period for public comment, the Secretary shall publish in the Federal Register a proposed regulation or guidance for public comment. The Secretary shall provide 90 days for public comment.

`(iv) Not later than 90 days after the end of the period for public comment, the Secretary shall publish in the Federal Register a final regulation or guidance.

`(C) The Secretary may on the Secretary’s own initiative, and shall in response to a petition submitted by an interested person, reconsider any tolerance level established under subparagraph (A) or (B), using the same procedure established in this paragraph (1).

`(D) Any regulation or guidance, including any revised regulation or guidance, shall apply to cosmetics first shipped in interstate commerce beginning two years after the date of issue of the regulation or guidance, unless the Secretary determines, after public notice and an opportunity for public comment, that an earlier effective date is required to prevent serious adverse health consequences or death.

`(2) The failure of the Secretary to comply with any applicable time period requirement under paragraph (1) shall constitute final agency action for purposes of judicial review. If the court conducting such review determines that the Secretary has failed to comply with the requirement, the court shall order the Secretary to comply within a time period determined by the court to be appropriate, but in no event later than 90 days following the court’s order.

`(c) Priority List- Within 180 days after the date of enactment, the Secretary shall establish a publicly available electronic priority list of nonfunctional constituents in cosmetics for review under this section. The Secretary shall begin and complete a review of at least one such priority nonfunctional constituent every 365 days.

`(d) Application- A tolerance level established by the Secretary under this section shall apply in every State.’.

SEC. 8. COSMETIC INGREDIENT REVIEW.

Chapter VI, as amended by sections 3, 4, 5, 6, and 7, is amended by adding at the end the following:

`SEC. 609. COSMETIC INGREDIENT REVIEW.

`(a) Panel’s Recommendation- The Cosmetic Ingredient Review Expert Panel determination in an approved final report that a cosmetic ingredient–

`(1) is safe for use in cosmetic products without the need for specified conditions of use;

`(2) is safe for use in cosmetic products under specified conditions for use;

`(3) is not safe for use in a cosmetic product under any conditions of use;

`(4) requires more information in order to make a determination whether the ingredient is safe for use in a cosmetic product under any conditions of use; or

`(5) is the subject of any other type of determination by the Cosmetic Ingredient Review Expert Panel, shall be deemed to constitute a recommendation that the Secretary accept that determination for purposes of implementing and enforcing this chapter in accordance with the effective dates established under subsection (d).

`(b) Secretary’s Determination- The Secretary shall be deemed to accept that determination and recommendation unless the Secretary at any time determines, by regulation or guidance, after public notice and an opportunity for public comment, to make a different determination. A determination and recommendation described in subsection (a) that is deemed to be accepted by the Secretary shall be implemented and enforced by the Secretary by banning any use of any ingredient that does not conform to the specified safe conditions of use under subsection (a)(2) and any ingredient described under subsection (a)(3) or (4).

`(c) Proprietary Data- The determination described in subsection (a)(4) shall not apply to a person using the ingredient who has adequate safety substantiation and provides that substantiation to the Secretary as confidential business or trade secret information that shall not be publicly disclosed under section 301(j) of this Act or sections 552(b)(4) of title 5 or 1905 of title 18, United States Code.

`(d) Effective Dates- Subsection (b) shall be effective–

`(1) three years after the date of enactment for ingredients that are the subject of an approved final report as of the date of enactment of this subsection; and

`(2) two years after the date of approval of the final report for ingredients that are the subject of an approved final report after the date of enactment of this subsection.

`(e) Secretary’s Representative- The Secretary shall appoint a representative who shall be a member of and shall participate in the deliberations of the Cosmetic Ingredient Review Expert Panel.

`(f) Application- A safety determination accepted or made by the Secretary under this section shall apply in every State.’.

SEC. 9. COSMETIC INGREDIENT SAFETY.

Chapter VI, as amended by sections 3, 4, 5, 6, 7, and 8, is amended by adding at the end the following:

`SEC. 610. COSMETIC INGREDIENT SAFETY.

`(a) In General-

`(1) The Secretary may on the Secretary’s own initiative, and shall in response to a petition submitted by an interested person, including a State, under subsection (b) or in accordance with the provisions under subsection (c), evaluate the safety of any ingredient intended for use as or in a cosmetic product and, after public notice and an opportunity for public comment, establish by regulation or guidance the conditions, if any, under which the ingredient is safe for human use.

`(2) In evaluating the safety of any such ingredient, the Secretary shall apply generally recognized principles of scientific risk assessment and shall take into account–

`(A) the conditions of use recommended or suggested in the labeling;

`(B) any relevant safety evaluation conducted by the Cosmetic Ingredient Review Expert Panel; and

`(C) all relevant unpublished and published safety data and information, including human exposure during marketing.

The Secretary shall determine the conditions for the use of the ingredient that are necessary for safe use, or that the ingredient is safe for use without the need for specified conditions of use, or that there are no conditions under which the ingredient can be safely used.

`(b) Procedure-

`(1)(A)(i) If the review of an ingredient is being conducted on the Secretary’s own initiative or under subsection (c), the Secretary shall initiate the proceeding by publishing in the Federal Register a proposed regulation or guidance. The Secretary shall provide 180 days for public comment.

`(ii) Not later than 180 days after the end of the period for public comment, the Secretary shall publish in the Federal Register a final regulation or guidance.

`(B)(i) If the review of an ingredient is being conducted in response to a petition submitted by an interested person, the Secretary shall publish the petition in the Federal Register for public comment not later than 60 days after receipt of the petition. All appendices to the petition shall be made available on the Secretary’s website. The Secretary shall provide 180 days for public comment.

`(ii) Any such petition shall specify the ingredient, the uses for which the ingredient is intended, any proposed conditions of safe use, and the scientific data and information, including human exposure during marketing, on which the proposed conditions are based.

`(iii) Not later than 180 days after the end of the period for public comment, the Secretary shall publish in the Federal Register a proposed regulation or guidance for public comment. The Secretary shall provide 90 days for public comment.

`(iv) Not later than 90 days after the end of the period for public comment, the Secretary shall publish in the Federal Register a final regulation or guidance.

`(C) The Secretary may on the Secretary’s own initiative, and shall in response to a petition submitted by an interested person, reconsider any conditions for safe use established under subparagraph (A) or (B), using the same procedure established in this paragraph (1).

`(D) Any regulation or guidance, including any revised regulation or guidance, shall apply to cosmetics first shipped in interstate commerce beginning two years after the date of issuance of the regulation or guidance, unless the Secretary determines, after public notice and an opportunity for public comment, that an earlier effective date is required to prevent serious adverse health consequences or death.

`(2) The failure of the Secretary to comply with any applicable time period requirement under paragraph (1) shall constitute final agency action for purposes of judicial review. If the court conducting such review determines that the Secretary has failed to comply with the requirement, the court shall order the Secretary to comply within a time period determined by the court to be appropriate, but in no event later than 90 days following the court’s order.

`(c) Priority List- Within 180 days after the date of enactment, the Secretary shall establish a publicly available electronic priority list of cosmetic ingredients. The Secretary shall begin and complete a review of at least one such priority cosmetic ingredient every 365 days.

`(d) Application- A safety determination accepted or made by the Secretary under this section shall apply in every State.’.

SEC. 10. NATIONAL COSMETIC REGULATORY DATABANK.

Chapter VI, as amended by sections 3, 4, 5, 6, 7, 8, and 9, is amended by adding at the end the following:

`SEC. 613. NATIONAL COSMETIC REGULATORY DATABANK.

`In order to consolidate all information pertaining to regulation of the safety of cosmetics in one place for use by State officials responsible for the regulation of cosmetics and by the general public, the Secretary shall establish and maintain in the Center for Food Safety and Applied Nutrition (or any successor organization of such Center) of the Food and Drug Administration an electronic National Cosmetic Regulatory Databank that shall contain the information submitted to the Secretary under sections 604, 605, and 606, and such other information pertaining to the regulation of cosmetics as the Secretary shall deem appropriate. Information in the National Cosmetic Regulatory Databank that is not subject to public disclosure under section 552 of title 5, United States Code, may be disclosed on request to the director of a State agency responsible for regulating the safety of cosmetics, and such official and other State employees who have access to such information shall then be subject to the provisions of section 301(j), subsection 552(b) of title 5, United States Code, and section 1905 of title 18, United States Code, with respect to such information. Information available in the National Cosmetic Regulatory Databank shall not be subject to State laws on submission of that information, whether in the same or a different format.’.

SEC. 11. COSMETIC RECORDS INSPECTION.

Chapter VI, as amended by sections 3, 4, 5, 6, 7, 8, 9, and 10, is amended by adding at the end the following:

`SEC. 614. COSMETIC RECORDS INSPECTION.

`If the Secretary has a reasonable belief that a cosmetic product, and any other related cosmetic product that the Secretary reasonably believes is affected in the same manner, is adulterated and presents a threat of serious adverse health consequences or death to humans, each person who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person setting forth the basis for the Secretary’s belief, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy records that are needed to assist the Secretary in determining whether the cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans. The Secretary shall prevent the disclosure of trade secret or confidential information obtained by the Secretary pursuant to this section. This section does not extend to cosmetic product formulas, financial data, pricing data, personnel data, research data, or sales data other than shipment data.’.

SEC. 12. RULES OF CONSTRUCTION.

Chapter VI, as amended by sections 3, 4, 5, 6, 7, 8, 9, 10, and 11, is amended by adding at the end the following:

`SEC. 615. RULES OF CONSTRUCTION.

`(a) Cosmetic Products- Whenever the term cosmetic or cosmetics is used in sections 604, 605, 606, or 607, it shall be deemed to refer only to a cosmetic product or cosmetic products. A cosmetic product that is subject to the caution legend in section 601(a) shall not be subject to the provisions of sections 608, 609, or 610.

`(b) Contractors- A requirement for registration of a cosmetic establishment under section 604, submission of a cosmetic and ingredient statement under section 605, or submission of a serious and unexpected adverse event report for a cosmetic under section 606, may be satisfied by a person who contracts to perform that function for the person who is required to register or make the submission.

`(c) Exemptions- The Secretary may, in the Secretary’s discretion, establish exemptions from the requirements in this title for the efficient and cost-effective implementation of these provisions.

`(d) Safety- For purposes of chapter VI, a cosmetic shall be deemed to be safe if it does not present a risk of significant illness or injury to humans under the conditions of use recommended or suggested in the labeling.’.

SEC. 13. CONFORMING AMENDMENTS.

(a) Section 301 is amended by adding at the end the following:

`(aaa) The failure to register a cosmetic establishment required to be registered under section 604 or to maintain the registration current and accurate.

`(bbb) The failure to submit a cosmetic and ingredient statement required under section 605 or to maintain the statement current and accurate.

`(ccc) The failure to submit a serious and unexpected adverse event report or to include on a label the domestic telephone number through which a report of a serious and unexpected adverse event may be received, as required under section 606.

`(ddd) The failure to comply with cosmetic good manufacturing practices established under section 607.

`(eee) The failure to comply with a tolerance for a nonfunctional constituent in cosmetics established under section 608.

`(fff) The failure to comply with a determination with respect to the safety of a cosmetic ingredient under section 609 or section 610.

`(ggg) For a cosmetic product that is being imported or offered for import, the failure of the importer to present both the unique cosmetic establishment registration number established by the Secretary under section 604(a) and the unique cosmetic and ingredient statement number established by the Secretary under section 605(a).’.

(b) Section 301(j) is amended by inserting `605, 609, 613,’ after `573,’.

SEC. 14. NATIONAL UNIFORMITY FOR COSMETICS.

Section 752 is amended–

(1) by amending the section heading to read as follows: `national uniformity for cosmetics’;

(2) in subsection (b), by inserting `or (f)’ after `subsection (a)’; and

(3) by adding at the end the following:

`(f) Cosmetic Safety-

`(1) IN GENERAL- Subject to paragraphs (2) and (3), no State or political subdivision of a State may establish or continue in effect any law, regulation, order, or other requirement relating to cosmetic constituents, cosmetic ingredients, or cosmetic products–

`(A) that is different from, in addition to, or otherwise not identical to, the provisions of chapter VI and the requirements and determinations established or accepted by the Secretary thereunder; or

`(B) relating to registration, listing, or fees for establishments, products, ingredients, or constituents, or to submission of reports.

`(2) STATE PETITIONS- Not later than 180 days after the date of the enactment of this subsection, a State may petition the Secretary under section 609 or 610 to establish as a national standard a tolerance for a nonfunctional constituent or a safety requirement for a cosmetic ingredient that exists in a State law or a duly promulgated State regulation that is effective on the date of enactment of this subsection. Pending completion of the process established under section 608 or 610, the State requirement shall remain in effect for that State. Upon completion of the process established under section 608 or 610, the final regulation or guidance published by the Secretary in the Federal Register shall be the national safety standard for the constituent or ingredient.

`(3) REQUIREMENTS ADOPTED BY STATE PUBLIC INITIATIVE OR REFERENDUM- This subsection shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to the enactment of this subsection.’.

SEC. 15. IMPORTATION.

Section 801(a) is amended by adding at the end the following:

`If a cosmetic product is being imported or offered for import into the United States and the importer does not present both the unique cosmetic establishment registration number established under section 604 and the unique cosmetic and ingredient statement number established under section 605, or the registration number or statement number is not correct and accurate, the cosmetic product shall be denied entry.’.

SEC. 16. AUTHORIZATION OF APPROPRIATIONS.

Chapter VI, as amended by sections 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12, is amended by adding at the end the following:

`SEC. 616. AUTHORIZATION OF APPROPRIATIONS.

`To carry out this chapter and section 752, there is authorized to be appropriated $11,700,000 for each of fiscal years 2014 through 2018. The Secretary shall annually allocate for personnel and functions for the regulation of cosmetics during the period of such fiscal years at least $11,700,000 out of the total funds appropriated for the Food and Drug Administration, 10 full-time equivalent personnel in the Office of Regulatory Affairs, and 1 full-time equivalent lawyer in the Office of Chief Counsel.’.

SEC. 17. EFFECTIVE DATES.

(a) Sections 3, 4, 5, 6, and 15 of this Act shall be effective on the later date of–

(1) one year after the Secretary of Health and Human Services promulgates final regulations or guidance implementing these sections; or

(2) one year after the Secretary of Health and Human Services publishes a notice in the Federal Register determining that an effective electronic system has been established and is operational for the submission of cosmetic manufacturing establishment registrations, cosmetic and ingredient filings, reports of serious and unexpected cosmetic adverse events, good manufacturing practices for cosmetics, and the National Cosmetic Regulatory Databank.

(b) The remaining sections of this Act shall be effective on the date of the enactment of this Act.

END

Review original bill text The Library of Congress

In the past few days we’ve looked at sunscreen regulations in the USA and EU; today we will examine Asia. As I mentioned in part 1, there is no continuity in regulating sunscreen around the world. As a continent, Asia’s various countries have different regulations, SPF ratings and registration requirements and guidelines to bring sunscreens to market. This information was presented by Alain Khaiat, Ph.D. of Seers Consulting during a very informative half day scientific seminar I attended at In-Cosmetics Barcelona. Let’s break things down by specific countries, taking a look at maximum SPF, how sunscreens are classified, and the process of  bringing product to market:

1. In China, sunscreens fall under the category of specialty cosmetics. They have capped the maximum allowed SPF rating at 30+. The process to bring a new sunscreen to market takes about a year, which includes testing at a Chinese government recognized lab. China requires a final product formulation, specs, manufacturing process and claim support documents for SPF and clinical testing reports to be on file with the government. They also require a safety assessment on any product that is considered to contain a risky substance as well as 3 dozens of product samples provided for testing. The product must have a Chinese name, and all artwork on the packaging must also be in Chinese.

2. Korea classifies sunscreen as “Functional Cosmetics” and caps the maximum SPF at 50+. Korea requires a product sample for registration, and reports on tests methods for both active ingredients and finished product. This includes the background of origin, development and final formulation. In addition, Korea requires any SPF or efficacy data and testing info to be provided by a test supervisor with more than 5 years experience in a respective field. If the manufacturer is introducing a new sunscreen active ingredient, they must provide additional safety data for any and all new actives. In Korea the manufacturer must also provide all fragrance information, including a components list of the fragrance. The registration process is 6 months.

3. In Taiwan, sunscreens are “Medicated Cosmetics” with a maximum SPF of 50+. The registration lead time is 4 months and requires a “Free Sales Certificate” which needs to be notarized by a cosmetic association. This notarization is not necessary if the certificate was issued by the FDA. The final formulation must include percentages by INCI name. They do not require any product samples for registration, only a photocopy of the primary packaging. All artwork on the packaging must be in Chinese with a Chinese product name.

4. In Japan and ASEAN* (Association of Southeast Asian Nations), there is “notification” rather than a registration process to bring a sunscreen to market. This notification process entails a 2 week lead time where companies must provide specific information on product formulation, including ingredients, name, level and function, along with their stability testing and a special certificate if amy animal derived material* is used in the formula. Japan allows a maximum SPF of 50+.

*ASEAN is similar to Japan, but there is not a special certificate required for animal derived materials, and they do not have a maximum allowed SPF rating.

Hong Kong has no regulations for bringing sunscreen to market or limits on maximum SPF ratings.

In the fourth and final post in this series, we’ll be wrapping up and shining the spotlight on Sun Protection in Australia and India.

References

Scientific seminar presentation at In-Cosmetics Barcelona by Alain Khaiat, Ph.D.,  Seers Consulting

In part 1, we looked at the current regulations on sunscreens and SPF ratings in the USA presented by Anne-Gael Glaverec. Part 2 will examine the European Union (EU) which was also covered in Anne’s very informative presentation. Sunscreens in the EU are considered cosmetics and currently regulated by the European Cosmetic Directive (76/768/ECC)*. After July 11, 2013, they will fall under the new European Cosmetic Regulation (EC 1223/2009)* which I have learned a great deal about here at In-Cosmetics and will be covering in a upcoming post.

The EU has 26 registered UV filters that are allowed in specific concentrations in sunscreens. Currently, zinc oxide and titanium dioxide are not considered approved filters in the EU. Any individual ingredient claiming sunscreen protection also has to be registered and approved in the EU before being incorporated in to a sunscreen formulation. On top of this, specific UV filters need to be in compliance with a separate Chemical Legislation called REACH (EC 1907/2006). Due to this, the process of bringing a new sunscreen to market is very expensive and time consuming. It can take anywhere from ~4-7 years to complete the safety doser and SCCS safety evaluation process before bringing the UV protectant ingredient to market to be used in sunscreens. The good news is these specific ingredients are generic, not brand specific, so once the filter is approved it may be used in other formulations without the ~4-7 year process. The sunscreen must meet the EU industry guidelines for Evaluation of Water Resistance which was released in 2005. ISO tests must be conducted to evaluate the SPF rating and UV protection through in-vivo and in-vitro testing.

The EU has a minimum SPF rating of 6, with UVA protection being at least 1/3 of the SPF. The EU has developed testing categories that determine the SPF value. For example:

~if the sunscreen performs in tests with an SPF of 6-14.9, it must be labeled with an SPF value of SPF 6-10, considered “Low Protection“.

~”Medium Protection” tests at levels of SPF 15-29.9 and will be given the SPF ratings of 15, 20, or 25 according to the test results.

~”High Protection” tests must show ratings of 30-59.9 and may claim a SPF of 30-50 on the product.

~”Very High Protection” must test in at > or = to 60, but are only allowed to carry the maximum SPF rating of  50+ (like the US) on the label.

The EU has also instituted banned labeling claims such as “total protection”, “100% protection”, “sunblock” and “all day prevention” on any marketing info associated with the sunscreen. The EU has taken this one step further by instituting pictograms* for labeling to help the consumer understand the SPF rating and safety.

The biggest change to come in the EU will happen when the implementation of the EU Cosmetic Regulation 1223/2009 goes into effect in July 2013. Nano labeling will be required at that point for sunscreens in the EU, and approval of both zinc oxide and titanium dioxide are expected to be passed by 2013 in the EU.

*please see references for more info

References:
Anne-Gael Glaevic – presentation on EU and US regulatory status for sunscreen at In-Cosmetics 2012 Barcelona

EU Cosmetic Directive 76/768/EEC: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1976L0768:20100301:en:PDF

EU Cosmetic Regulation No 1223/2009 (goes into effect July 11, 2013): http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32009R1223:EN:NOT

Pictogram’s to inform consumers on dangers linked to sun exposure created by the EU Commission: http://ec.europa.eu/health-eu/news/sun_uv_en.htm

EU Commission Consumer information: http://ec.europa.eu/consumers/citizen/my_holidays/sunscreens_en.print.htm

When it comes to sunscreen, standards and regulation around the globe, there is no global harmonization. However, sunscreen is highly regulated in each country. Sunscreens are considered cosmetics, but fall under their own regulation categories. Each country has their own approved methods for testing efficacy; this includes approved UV filters, SPF ratings, and any label claims or warnings. Part 1 will provide an overview of the US regulations, presented by Anne-Gael Glaevic, a group leader in Global Regulatory Affairs in Personal Care. I’ll review the differences in EU and Asia regulations in following posts.

Bringing a Sunscreen to Market in the United States

In the US, sunscreens are considered OTC (over the counter) drugs that are regulated by the FDA. Any products with a sunscreen claim must be registered prior to use to be in compliance. There are 2 ways to bring a new sunscreen to the market in the US:

1. Ingredients must be in compliance with the OTC sunscreen monograph which was released in 1999. This includes following the regulatory standards set up by the FDA; active ingredients, labeling and marketing claims must comply. Only registered UV filters are allowed through this method. There are 16 approved filters at a given maximum concentration listed in the 1999 OTC monograph. Companies may use a combination of these approved filters in their products, but the combos must be registered as well. There are also specific regulations on how these filters can be combined, and in what percentage the various combinations are allowed.

2. New Drug Application (NDA) is for finished products with new UV filters, or a new combination of filters that are outside of the already approved percentages in the OTC monograph. NDA is a year and a half process to get reviewed and approved for the finished product. There is one other option, TEA (time and extended application) that falls under NDA for sunscreens that already have 5 years of safe sales in another country. This is a slightly longer process to get approved by the FDA with a 2 year registration process with no pending issues.

Anne pointed out that both processes are very time consuming and expensive. It’s important to also acknowledge that when compared to other areas of the world, the USA is not as strict in the area of bringing new sunscreens to market!

In 2011, the US passed new sunscreen labeling claim guidelines that companies must abide with this year in order to be in compliance. Here are the main changes:

1. The verbiage used in claims “waterproof” “100% protection” “sweatproof” “sunblock” are no longer allowed on product packaging or marketing claims. “Water Resistant” must be used instead, and specifically designated as 40 or 80 minutes in the water.
2. Limit SPF to 50+
3. Broad spectrum claims for SPF 15+: The US is the only country that has approved this verbiage for broad spectrum claims on UVA and UVB protection that must be listed under the “drug facts” on the back of the label “If used as directed with other sun protection measures this product reduces the risk of skin cancer and early skin aging as well as helps prevent sunburn”
4. Any sunscreen under SPF 15 may only make this claim “This product has been shown only to prevent sunburn, not skin cancer and early skin aging

Apparently there will be a future publication of the US Final Sunscreen Monograph to come…

References:

Anne-Gael Glaevic – presentation on EU and US regulatory status for sunscreen at In-Cosmetics 2012 Barcelona

Final Ruling on Labeling and Testing: http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14766.pdf

Understanding Over-the-Counter Medicines > Sunscreen: http://1.usa.gov/IJmFUK

Labeling and Effectiveness Testing http://www.regulations.gov/#!documentdetail;D=FDA-1978-N-0018-0698

Rulemaking History for OTC Sunscreen Drug Products http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-counterOTCDrugs/StatusofOTCRulemakings/ucm072134.htm

Right now, I’m on the plane to Barcelona reviewing the wealth of information that will be presented on April 17-19 at the In-Cosmetics conference. Here’s a preview of what’s in store at the largest global platform for cosmetics ingredients this year:

The Innovation Zone will host presentations on the latest ingredients, raw materials, technologies and formulation techniques. The most innovative ingredients from sun care actives to anti-aging will be showcased and competing for the Best Ingredient Award. The Award honors the development of a functional ingredient that combines innovative science and product features in a way that demonstrates substantial benefits to manufacturers and consumers when compared with existing ingredients. You can view a list of the finalists for this award here. In addition, over 500 suppliers will be showcasing their ingredients and innovations at the conference.

A series of Scientific Seminars will cover the intricacies on everything from the EU ban on animal testing to the latest in sun care formulation and Cosmetogenomics – the cutting edge of cosmetic science focused the latest gene expression studies. I’ll be attending the Spotlight on Sun Protection and sharing the wealth of info and innovation in posts to come.

There will be over a dozen presentations, live discussions and interviews throughout the conference on Marketing Trends led by industry experts and market researchers who will analyze the current cosmetic ingredient markets while examining areas for potential growth.

I’ll be speaking on a panel the opening day at noon on Reinventing Beauty: Breaking with Traditional Dimension for Growth. We’ll examine the Euromonitor’s findings including the future of the beauty industry, looking at new product positioning, the competitive landscape, innovation, evolving patterns of retail and new growth models.

I’ll be covering In-Cosmetics 2012 throughout this week and after the conference to share the innovative presentations, panels and discussions with our readers. You can interact throughout the 3-day conference by asking questions to @prsnalcaretruth or @grapeseedco on twitter, or leaving your questions or comments on our PCT Facebook page, posting a discussion to the In-Cosmetics Group on linked-in or commenting on posts.

You can still register (for free!) to attend In-Cosmetics 2012 here. I look forward to your questions and sharing this experience with you!