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!

My job is varied and interesting but it also does my head in.  Why?  Because everything is interesting, everything is an opportunity to learn more, be better, run faster, jump higher and solve world hunger (well, no it isn’t really but anyway) and that can become totally overwhelming.  Anyway……….

It just so happens that I’ve found myself in a surfactant bubble for the last four months  after having been invited to formulate quite a few products for quite a few different companies (8 in fact which is a nice neat number).  Anyway, not one to churn out the same old-same old day after day I’ve been playing and found a few rather fabulous combinations to tickle the taste buds and lick the dirt off even the most crusty of customers (and before you get excited that’s salt on the scales there. Table salt).

But I can’t tell you about all of that here because it’s top secret so instead I thought I’d share some basic overview notes with you about how surfactants work as believe it or not, there’s some science involved. No, really I’m serious about this science stuff………….

My notes on surfactant chemistry.

Too hard to read?  Try this:

Anionic Surfactants form charged micelles that act like little magnets picking up dirt. They pull the dirt from a surface and it is emulsified away from the surface. This is more of a physical reaction in-situ than a chemical one as the dirt isn’t changing form on the skin as such – it is emulsified in the rinse.

They can form sphere, rod or disk-shaped micelles and it is the spheres that form the thickest mixtures. 

They work best just above their CMC (Critical micelle concentration) as this is when the surface activity is highest   = largest surface area.

Bigger aggregates can form and these are otherwise known as liquid crystals (emulsifiers form these sometimes)

Salt decreases the surfactant CMC  which means that less irritating and more effective formulations can be created for a lower cost. They are also more efficient for the environment as less material needs to be used. Salt works best with anionics. 

Anionic and Cationic surfactants generally have higher CMC’s than non-ionics due to the interactions between the head groups. However, this can be dramatically reduced with the addition of amphoterics.

Glucosides are non-ionic and tend to remove dirt by emulsifying it.  This is a chemical reaction that occurs at the site of the dirt. You rinse off the emulsified oil.

 Glucosides have lower HLB’s as the chain length reduces so C8 has a high CMC (Caprylic) at 18 whereas C10 has only 1.8 (capric).  C12 has a CMC of 0.18.

Decyl and Cocoyl glucoside have the same range of chain lengths C8-C16 which is also known as a broad cut.

Zwiteronic surfactants such as cocamidopropyl betaine have smaller CMC’s than anionics.

Most but not all modern surfactant systems combine mixtures of all three types of surfactant to give highly effective cleaning solutions.  There are some useful synergies between different surfactant groups but some are good enough to use alone. Depends on what you want really. 

Getting my hands ‘dirty’ or thoroughly degreased (I only use mild surfactants but they are still potent – the dose makes the poison my dears).

I’ve been playing with surfactants for a good 13 years now after being lucky enough to work alongside some of Akzo Nobel’s greatest back in the 90′s. These years have been pretty interesting as the push to greener and more sustainable surfactants picked up its pace. When I joined the industry cleaning companies were still relying on nonyl phenol ethoxylates and harsh (and I mean harsh) solvents to clean our hard surfaces whereas nowadays most are using much more degradable and less polluting ingredients.  The cosmetics industry has also seen an evolution and although many of the multinationals are sticking with their SLES/ Betaine type shampoos and bubble baths (because they work, are cost-effective, relatively mild and are actually ‘greener’ than ever due to efficiencies in processing etc) more and more brands are playing with some newer stuff such as lactylates,  glucosides, amino-acid derived surfactants and natural saponins.

The point of showing you this is two fold. A) Because there is some really interesting science behind why I do what I do and I do think that it is important to share that and most importantly B) Because I want to encourage you, the product maker, the interested reader, the health provider, the hobbyist or the environmentalist to discuss the ingredients that we use in cosmetics in an intelligent and thoughtful way so that we can come up with bigger, better, faster, stronger, world-hunger curing solutions together.

That sound OK?  Great, let’s get cooking!

Last Wednesday, I posted the proposed bill, H.R.4262 Cosmetics Safety Enhancement Act of 2012. I’m not touching on the finer points of this legislation today, as we are still going through it with a fine tooth comb. However, Section 604 got me thinking about something we covered last year and I wanted to take it a step further.

`SEC. 604. REGISTRATION OF COSMETIC FACILITIES AND COSMETIC PRODUCT LISTING reminds me of what a great many companies are already doing in the Voluntary Cosmetic Registration Program (VCRP).

When I formulated products, I participated in the VCRP. It was remarkably easy and the information asked was very minimal. I registered my company, my individual products and the ingredients for those products. When listing ingredients with the VCRP, it’s no different than listing them on a website or a product label. They are listed the same way in the VCRP; in descending order of predominance.

While I am at it, I’d like to clear up a misconception being spread by many on the internet. Listing ingredients on a product is not an option, it is a requirement. There are rules and guidelines that must be followed. You can read more about the Federal Food, Drug and Cosmetic Act (FD&C Act), Fair Packaging and Labeling Act (FP&L Act).

Why is it important to register your company, products and ingredients? As I asked Don Havery in the VCRP post above, I will share this main questions again:

Why should a manufacturer register with the VCRP?

The VCRP helps FDA in its mission to protect consumers. It also helps cosmetic manufacturers and distributors make informed decisions about ingredient use in their products. For example, if it is determined that a cosmetic ingredient presently being used is harmful and should be removed from product use, FDA can notify the manufacturers and distributors of affected products. Since the VCRP is the only source of information about what products are on the market, firms that do not participate in the program won’t receive that information directly. Information from the VCRP database also assists the Cosmetic Ingredient Review (CIR) Expert Panel in determining its priorities for ingredient safety review. The CIR is an industry-funded panel of scientific experts that regularly assesses the safety of cosmetic ingredients. Since cosmetic manufacturers are responsible for assuring that their products and the ingredients in them are safe, participating in the VCRP is one way of supporting the safety review process since VCRP data is used to by the CIR safety review program (See http://www.cir-safety.org).

Now I’d like to share a scenario with you:

1. Manufacture A is formulating product X, using ingredient Z, and has registered their company, products and ingredients with the FDA.
2. Manufacturer B is formulating product Y, using ingredient Z, and has not registered their company, products and ingredients with the FDA.
3. The FDA recalls ingredient Z, and sends out an email alert telling all the companies that have registered their company, products and ingredients with the FDA, to stop using ingredient Z.
4. Manufacture A removes ingredient Z from their raw material inventory, and recalls all products that contain ingredient Z, that may be in the marketplace.
5. Manufacturer B is continuing to formulate using ingredient Z because they did not receive an email. Why? Because the FDA was unaware they were using ingredient Z.

Do you see where I am going with this? How is manufacturer B supposed to know that ingredient Z can no longer be used in formulating a product? Sure, manufacturer B can scour the FDA website, the Cosmetic Ingredient Review website or other sites that would post this information, but what if they miss it? Quite frankly, I wouldn’t want to take that chance of not being made aware of an ingredient recall.

I used to be a manufacturer. I’m still a consumer.

What are your thoughts on registration?

I am not against transparency in labeling. I think it’s a subject that could use a lot of discussion. But I am against ingredient obsession. In a society that allows alcohol, tobacco and firearms to be freely purchased, and that turns a blind eye to the widespread use of illegal drugs, why are we concerned about whether a consumer product might contain a few parts per million of chemical X? Should we not be concerned, rather about whether the product itself is safe?

Ingredient tunnel vision is seriously bad for your health. It will turn you into an obsessive, paranoid, vicious, spitting fireball of righteous indignation. You will write searing blog posts, develop gastritis or worse, lose sleep, and die young. And for what? Essential oils and their constituent chemicals are very frequent targets. Because essential oils contain chemicals, and because almost all chemicals are, to some people, toxic by definition, many bloggers in the green movement have become anti-fragrance and anti-essential oils. For a while I though that, when they realize that linalool is found in lavender oil, and that limonene is in lemon oil, they will relent. I was wrong. Obsession is, in fact, relent-less. It allows no release, no vacation, no light side. It is all-consuming!

Because essential oils are alleged to contain “allergens”, they are also favorite targets of regulators and legislators, especially in Europe. And, we in North America know full well that whatever happens in Europe must be good, because Europeans are more intelligent. Their accents prove this. Since I have been living in the US (12 years now) my accent has slowly become less English English, and more American English, and my mental faculitoes have detturiated protortionisely, as you kan see.

Peer-not
More on Europe soon. But first, a new study financed by Silent Spring Institute, written by Robin Dodson et al, and published in Environmental Health Perspectives. EHP claims to be peer-reviewed, but if this report is anything to go by, its reviewers need replacing. In fact, they might as well not bother with peering, since it clearly accomplished nothing. The report is entitled: Endocrine Disruptors and Asthma-Associated Chemicals in Consumer Products. Classes of chemicals that were tested for include UV filters, cyclosiloxanes, glycol ethers, parabens, phthalates, alkylphenols and fragrances. The “fragrances” tested for include these essential oil constituents:

For your edification, I have highlighted one essential oil and also some foods that naturally contain said chemical. No rationale is given for why these particular substances were selected. This is important, not only because they have now become what might be called “target chemicals of concern”, but because the list could have been so much longer. It could include almost every essential oil constituent in existence. Now, at a rough guess, this is in the region of 1,000. The above list is said to represent “asthma-related chemicals”. This is not defined anywhere, but the article begins with “Laboratory and human studies raise concerns about endocrine disruption and asthma from exposure to chemicals in consumer products” and it goes on to talk about “asthma-related chemicals.”

Fragrance chemicals do not cause asthma, but they can exacerbate asthmatic symptoms. Many fragrance chemicals have this potential because they are very mild respiratory irritants in concentration. It’s the nature of the beast. However, listing limonene, isobornyl acetate, terpineol etc., is not helpful. If you are asthmatic, and you tend to react badly to fragrances, then you stay away from fragrances. Mounting a new campaign to list particular fragrance ingredients on consumer labels will not accomplish anything. It will not meaningfully make fragrances safer, and if consumers need a warning that a product is fragranced, this can be accomplished in either one word: “FRAGRANCE”. Or two: “CONTAINS FRAGRANCE”.

The paper states that, if a compound is “available from plant materials”, it was described as natural, and if “commonly synthesized”, then it was described as synthetic. But there is no list! No classification! So we don’t know which they regard as natural, and which as synthetic! In the text, limonene is mentioned as being natural (correct), isobornyl acetate as synthetic (incorrect) and hexyl cinnamaldehyde as natural (incorrect, since it is always synthesized. It is also spelled wrongly throughout the article. I’m Just saying…).

No direct evidence is provided for any adverse health effects for any of these compounds, and there is no discussion of the factors involved, although several papers are cited: “Fragrances, particularly terpenes such as limonene, are associated with secondary chemical reactions in indoor air, and can contribute to the production of formaldehyde, glycol ethers, ultrafine particles, and secondary organic aerosols (Nazaroff and Weschler 2004; Singer et al. 2006). Exposure to fragrances has been associated with a range of health effects, including allergic contact dermatitis, asthma and asthmatic exacerbations, headaches, and mucosal symptoms (Heydorn et al. 2003; Kumar et al. 1995; Steinemann 2009).”

Dodson and friends do not mention that moderate-to-high levels of ozone are required for these reactions to take place, nor that cleaning products (which can also contain volatiles such as formaldehyde, benzene, toluene and xylene) are the only ones that have been reported to cause actual health problems (Nazaroff and Weschler 2004). Ozone-limonene reactions can produce hydroxyl radicals, and these in turn can contribute to formaldehyde formation (Fan et al 2003). However, this was only observed under conditions that were admitted to be not typical of “nonindustrial indoor environments.” And, the statement that terpenes such as limonene can contribute to the formation of glycol ethers is not true. Nazaroff and Weschler (2004) state that both terpenes and glycol ethers were found in some cleaning products, not that one is formed from the other! And while I’m on my soapbox,, ultrafine particles and secondary organic aerosols are the same thing. Now, if I can find this many holes in a research paper without breaking a sweat, where is the so-called “peer-review”? And how much credence can we give any of the findings?

The Kumar et al (1995) study did find exacerbation of respiratory symptoms in asthma patients when they smelled perfume scent strips, as used in magazine advertising. And other research shows that if you give asthma patients strong fragrances to inhale, they may react adversely. The same is true for people with multiple chemical sensitivity, but it is not true of the general population.

Under extreme conditions terpenes such as limonene and pinene do form particles that are respiratory irritants. These conditions require (a) moderate-to-high ozone, and (b) substantial quantities of vaporized terpenes. These may be hazardous for vulnerable individuals, such as babies, older people, or people with asthma. However, it’s a leap to assume that fragrances cause health problems. They don’t. Yes, a fragrance could trigger an asthma attack in a person with asthma. But it cannot cause asthma. In a mostly supportive Forbes blog post based on Dodson’s article, Amy Westervelt quotes the following lines:

“This study presents a clear example of biased, advocacy-based research,” says William Troy, Ph.D., Scientific Advisor the International Fragrance Association North America. “It is a repackaging of older information and the methodology used defies basic principles and standards of scientific protocols and investigations. The advice to consumers based on study findings is simply wrong,” said Dr. Troy.

“There’s been a lot of work done on exposure to these chemicals in average households, and we know that these chemicals are found in air and dust in peoples’ homes, and the CDC [Center for Disease Control] has shown that we find them in our bodies as well,” says the study’s lead author Dr. Robin Dodson. “Now we’re trying to understand where the chemicals are coming from, and how people are exposed to them.”

There is a degree of naivete in this last statement. As far as the fragrant compounds are concerned, they are naturally found in some common foods (see Table), so that could be one reason that they are found in our bodies. Limonene and pinene are ubiquitous simply because so many trees produce them. If you have pine furniture, it is giving off limonene and pinene vapors. If you have paint thinned with turpentine, same deal, because turpentine is made from pine trees. If you live near trees…basically, if you’re breathing, you are inhaling limonene and pinene. How much you are inhaling, what the ambient ozone level is, and whether or not you have asthma are all considerations in whether these vapors might present a hazard. Some advice:

• If you are asthmatic, beware of strong fragrances.
• In high-ozone conditions (usually hot weather combined with factory exhalations and/or much vehicular traffic) beware of exposure to high levels of fragrant molecules.
• When using cleaning products, paints, glues or varnishes, ventilation is important.
• Note that some types of office equipment, such as photocopiers and fax machines, give off ozone.

Dodson advises avoiding fragranced products, and looking for ones with plant-based ingredients. So would that include or exclude essential oils? I’m baffled.

References
Dodson R, Nishioka M, Standley LJ et al 2012 Endocrine Disruptors and Asthma-Associated Chemicals in Consumer Products.

Fan Z, Lioy P, Weschler C et al 2003 Ozone-initiated reactions with mixtures of volatile organic compounds under simulated indoor conditions. Environmental Science & Technology 37:1811-1821

Heydorn S, Johansen JD, Andersen KE et al. 2003 Fragrance allergy in patients with hand eczema – a clinical study. Contact Dermatitis 48:317-323

Kumar P, Caradonna-Graham VM, Gupta S et al 1995 Inhalation challenge effects of perfume scent strips in patients with asthma. Annals of Allergy Asthma & Immunology 75:429-433

Nazaroff WW, Weschler CJ 2004 Cleaning products and air fresheners: exposure to primary and secondary air pollutants. Atmospheric Environment 38:2841-2865

Steinemann AC 2009 Fragranced consumer products and undisclosed ingredients. Environmental Impact Assessment Review 29:32-38