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Environmental

What are the guidelines for New Jersey Department of Environmental Protection (DEP) Air Pollution Investigations?

The New Jersey DEP established guidelines for the investigation of air pollution.  The citation is 28 NJR 198, originally published January 2, 1996.  The purpose of the Guidelines is to ensure consistency and that investigations objectively ascertain relevant facts and discern whether a violation has been committed.  The Guidelines are for use by Department Personnel performing air pollution investigations. http://www.nj.gov/dep/enforcement/sub_5_guidlines_39njr912.pdf

Export, Import & Transportation

Are GHS pictograms acceptable for IATA, IMDG and/or ADA or are separate transport labels necessary?

The obligations for transport labels must be followed independently from GHS.  In the EU CLP regulation, there is facilitation for GHS labeling if the packaging has been labeled according to transport legislation but not vice versa.

Does DEA support disposing of DEA controlled substances by mixing List I chemicals with non-controlled substances to amounts less than 20% thus removing the mixture from DEA jurisdiction?

Does such disposal eliminate the need to contact DEA?    

Under the DEA regulations, chemical mixtures are exempt as long as they are a combination of two or more chemical substances, at least one of which is not a List I or List II chemical.  In addition, to be an exempt mixture, the listed chemical must not be present at a concentration higher that what is permitted in the mixture rule.  The final mixture rule from 12/15/04  contains the concentration limits at the end of the publication.  Additional concentration limits were set for GBL in a separate rulemaking.

21 U.S.C. 802(40) defines the term "chemical mixture'' as "a combination of two or more chemical substances, at least one of which is not a List I chemical or a List II chemical, except that such term does not include any combination of a List I chemical or a List II chemical with another chemical that is present solely as an impurity.''   Therefore, a chemical mixture contains any number of listed chemicals along with any number of non-listed chemicals. A combination of only listed chemicals is, therefore, not a chemical mixture pursuant to CSA definition. Based on the regulations, this would appear to be an appropriate way to make these substances exempt from DEA regulation.

Flavor Labeling

For flavor labeling purposes, are use of the terms “nature identical flavor” or “natural identical flavor” appropriate in the United States?

No.  Information on the FDA definition of natural and artificial flavors can be found in the U.S. Code of Federal Regulations at 21 CFR 101.22.  In the United States, there is no classification for “nature identical” and “natural identical” flavors although the term has been used elsewhere, including Europe, for individual flavoring substances that are synthetically produced but that are identical chemically to their natural counterparts.  In the United States the appropriate term for labeling purposes of such synthetically derived (natural) flavoring substances is “artificial flavor” as called for by FDA at 21 CFR 101.22(a)(1).  For further information on flavor labeling questions you may wish to purchase the U.S. Flavor Labeling From Concept to Consumer Meeting Materials.  More information can be found here.

Food Safety/Supply Chain Integrity

Question on Sample Retention Under FSMA

The Preventative Controls Rule states:

  • Required records must be retained for at least 2 years after the date they were prepared
  • Records relating to general adequacy of equipment/processes being used by the facility (e.g., results of scientific studies used for validation) must be retained for 2 years after their use is discontinued.

Does this apply to retain samples? Does the FDA have a recommended size and time frame for retain samples?

Answer: The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC)/Technical Assistance Network (TAN) response:

For food products, FDA does not mandate collection and retention of retain samples.  The records requirements pertain only to records that must be established and maintained to demonstrate compliance with the preventive controls rules (e.g., records required in a food safety plan, and records documenting implementation of a food safety plan including monitoring of preventive controls, corrective actions, verification activities, supply-chain preventive controls, and training) were met.

Are registration requirements under the Food Safety Modernization Act (FSM) the same as that under The Bioterrorism Act, or is FDA going to have a second registration process?

Under FSMA the registration is the same as under the Bioterrorism Act however it has changed in the sense that it must be renewed. When the BT Act was passed, registration was originally a one-time requirement.  FSMA amends that provision and requires facilities to re-register every 2 years. The statute specifies that the re-registration period is between October 1 - December 31 every other year.  We expect that the re-registration obligations will begin in 2012, but FDA hasn’t announced specifics yet.  If a company registered under the BT Act, they will need to re-register every 2 years going forward. FSMA’s language modifies FFDCA section 415(a) (the Bioterrorism Act registration provision.

Does the Food Safety Modernization Act in any way dilute the protections of the Bioterrorism Act provisions that safeguard formulas, or does it require disclosure of ingredient concentrations?

The existing formula protections in the Bioterrorism (BT) Act are not affected by the new law.  The Food Safety Modernization Act (FSMA) amends the BT Act to provide FDA with access to: "[A]ll records relating to such article, and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals."  Essentially, this just expands the scope of the existing access to additional food products (e.g., other foods made on the same line).  However, it does not affect the existing protections in the BT Act. Under the BT Act, the records access provisions are expressly limited such that they do not extend to "recipes for food." With the addition of the new language, access would still be limited in such a manner so that formulas are still protected.

Does FDA have an emergency number should I ever need to get in touch with someone after hours about a supply chain issue?

Yes.  The U.S. FDA recently reported the new numbers for the Office of Emergency Operations at 1.866.300.4374 or 301.796.8240.  These numbers can be used to report a serious, life-threatening event involving FDA-regulated products including food and dietary supplements.

General

I have a new employee and need to get them signed up for access to the FEMA website and to receive FEMA alerts. How do I do this?

It’s easy.  You can contact Samantha Lee at [email protected] and make sure to provide the new employee’s name, title, email address, phone number and mailing address.  Be sure to include what committee updates/alerts if any you would like them to receive (for example, Alcohol Tax & Trade Committee, Flavor Labeling, FRAC, etc).  Once you have a member login, you can easily join a committee by clicking the button on the bottom of the Member Dashboard.

What is the FEMA GRAS™ Program?

The Expert Panel of the Flavor and Extract Manufacturers Association (FEMA) has served as the primary body for the safety evaluation of food flavorings for the flavor industry, and the public through its "generally recognized as safe" (GRAS) assessment of flavoring substances. Flavoring substances are determined to be GRAS by the FEMA Expert Panel pursuant to the authority granted in Section 201(s) of the U.S. Federal Food, Drug, and Cosmetic Act, which is administered by the FDA.

The FEMA GRAS™ assessment program continually incorporates the latest scientific advances for evaluating the safety of flavoring substances. The Expert Panel has operated continuously since it was first appointed in 1960. The Expert Panel's primary goal is to ensure that flavoring substances added to foods are safe for their intended use -- the conclusions of the Expert Panel on GRAS status apply only to the use of a flavoring substance in food. The Expert Panel is comprised of experts in the fields of chemistry, toxicology, pharmacology, medicine, pathology, and statistics; all are also experts in flavor safety assessment.

A critical part of the FEMA GRAS™ assessment program is the dissemination of the Expert Panel's decisions. Since 1965, lists of flavoring substances that have been determined to be GRAS have been published in a series of publications in the journal Food Technology. A comprehensive list of all the FEMA GRAS™ flavor ingredients and a list of (GRAS publications) is available. A small number of other flavoring substances are also permitted for use in the U.S. under separate authority as provided for in the U.S. Code of Federal Regulations (CFR); these substances, as well as a comprehensive list of all flavor ingredients listed in the CFR are available. Please note that the vast majority of the substances listed in the CFR are FEMA GRAS substances.

A number of articles have been published on the FEMA GRAS™ program. These include descriptions of the legal and scientific bases for the program (Hallagan and Hall, 1995); the history and operations of the Expert Panel (Oser and Ford, 1991); and scientific criteria employed by the Expert Panel (Oser and Hall, 1977, Woods and Doull, 1991 and Smith et al., 2005).

In addition to evaluating new substances for GRAS status, the Expert Panel carries out comprehensive, periodic reviews of all FEMA GRAS™ flavoring substances to reaffirm GRAS status. Recent publications on the GRAS reaffirmation of flavoring substances include reviews of alicyclic sustances, and lactones. Reviews of additional groups of substances will be published as the Expert Panel continues the GRAS reaffirmation program.

Based on the conclusions of the Expert Panel, FEMA GRAS™ flavoring substances are accepted as safe food ingredients in many countries around the world. 

Recent developments in the safety assessment of flavoring substances are reviewed by Munro, et al. 1998, who note the consistent application of safety assessment principles by the FEMA Expert Panel and other groups that perform safety assessments of flavoring substances. Another important publication is a review of the role of flavoring substances in food allergy and intolerance.

Additional information on the FEMA GRAS™ assessment program is available from Christie Gavin or Sean Taylor in the FEMA office.

There are a total of 23 FEMA GRAS™ publications referred to as "GRAS 3" through "GRAS 25" . The "GRAS 1" and "GRAS 2" publications were notices that did not contain lists of GRAS substances or other relevant information. All FEMA GRAS™ publications are available.

GRAS

Is quinine free base considered GRAS? Could you please clarify the following differences in the two data bases? We have received an MSDS from a new supplier that has CAS# 130-95-0 and named Quinine Base Anhydrous. Is this acceptable for use in the U.S.?

FEMA #

FEMA GRAS Database

IOFI Database

2976

CAS# 130-89-2-Quinine Hydrochloride-Quinine Chloride

Not Listed

2977

CAS# 6119-70-6-Quinine Sulphate

Cas# 130-95-06’-methyoxycinchonidineOnly approved for Mexico

The FEMA Expert Panel has not evaluated quinine free base (free amine quinine) so it itself is not considered GRAS.  FEXPAN evaluated the sulfate and chloride salts and since they do impart differing flavors, they were assigned two different FEMA numbers 2976 and 2977, respectively.  The quinine salts are part of GRAS 3 so they had been in common flavor use well before passage of the 1958 Food Additive Amendment.  Quinine free base is not readily soluble in aqueous systems and therefore represents a different specification profile than the sulfate or hydrogen chloride forms.  The attached report from the Merck Index as a reference regarding the solubility of quinine and its various salts.  From a chemical perspective one would have to titrate the free base down to a pH where the quinine would actually go into solution thus creating the salt.   

Quinine sulfate and quinine hydrochloride both have monographs prepared in the Food Chemicals Codex (FCC), which is recognized in the US Code of Federal Regulations .  No such monograph was prepared for quinine free base.  

In the United States, the first edition was given quasi-legal recognition in July 1966 by means of a letter of endorsement from FDA Commissioner James L. Goddard, which was reprinted in the book. The letter stated that “the FDA will regard the specifications in the Food Chemicals Codex as defining an ‘appropriate food grade’ within the meaning of Sec. 121.101(b)(3) and Sec. 121.1000(a)(2) of the food additive regulations, subject to the following qualification: this endorsement is not construed to exempt any food chemical appearing in the Food Chemicals Codex from compliance with requirements of Acts of Congress or with regulations and rulings issued by the Food and Drug Administration under authority of such Acts.”  

Subsequently, various additional specifications from previous FCC editions were also incorporated by reference, in the U.S. Code of Federal Regulations to define specific safe ingredients under Title 21, in various parts of Sections 172, 173, and 184. It is anticipated that FDA will from time to time continue to update its regulatory references to the FCC.  (FCC 7th ed., 2010)

Quinine chloride and quinine sulfate are part of the EU register.  They are included in the “Flavouring Substances Database” operated by the EU.  There is no entry for quinine free base.

Intellectual Property

What if I have a question that could be answered by those FEMA members knowledgeable on items such as flavor labeling or regulatory issues but I want to remain confidential?

That is not a problem.  FEMA staff is happy to assist you with your inquiry. For regulatory questions please contact Kelley Poole at [email protected].  We will reach out on your behalf in a confidential nature to get information and then report back to you.

International Regulations

If we use an only representative for REACH, how do we make the required classification notifications to ECHA?

According to the law, manufacturers and importers or a group of manufacturers and importers have the obligation to notify into the EU C&L inventory. EU based importers can do this on their own or with the help of a consultant. 

Does the IOFI notification to ECHA for CLP cover member companies or does each member company need to notify? Is there a mechanism by which a non-EU entity can perform the notification?

IFRA/IOFI did not make a notification ECHA – member companies or their representative must notify.

Is the two year extension for CLP only for single substances actually physically in the trade or is it for single substances that have been on the market in the EU and that will continue to be in the market and placed in trade channels after Dec 2010?

In the EU CLP regulation Art 61, paragraph 4 states that “ … substances….already placed on the market before 1 Dec 2010 are not required to be relabeled and repackaged… until 1 Dec 2010. …” This should apply also to substances that have been on the market and will remain after December 2010.

How should a supplier using a mixture in a preparation to be sold in the EU classify the preparation?

They should know the identity and concentration of all hazardous substances in the mixture so they can properly classify the preparation.

What is the best source for the proper labeling and pictogram information for a chemical for if its flavor or fragrance ingredient data sheet (FFIDS) has not been updated?

If the FFIDS has not been updated, or an updated classification is not in the FEMA/RIFM Database, then it has not been reviewed by the IFRA/IOFI GHS Committee.  The best source would then be the supplier.  If you are a supplier, then it is your responsibility to review the testing you’ve done on the material and make the proper classifications.

Is annatto allowed for use in Japan?

Yes, it is allowed. The following information is the Japanese Food Additive Official Standard for Water Soluble Annatto.

Annatto, Water-soluble Definition:  Water-soluble Annatto is prepared from the red pericarp of seeds of the annatto tree Bixa orellana Linné by hydrolysis. The coloring principle is the potassium or sodium salt of norbixin.

Content:Water-soluble Annatto contains the equivalent of 100C125% of the labeled content of norbixin (C24H28O4=380.48).

Description:  Water-soluble Annatto occurs as a red-brown to brown powder, lumps, liquid, or pasty substances having a slight characteristic odor.

Identification
(1) Dissolve 0.5 g of Water-soluble Annatto in 20 ml of water, add 2 ml of diluted sulfuric acid (1 in 20), shake, and filter. Wash the residue on the filter paper three times with 20 ml of water each time.
(i) Dissolve a little portion of the residue in sodium hydroxide solution (1 in 2,500). The solution exhibits absorption maxima at wavelengths of approximately 452C456 nm and 480C484 nm.
(ii) Dissolve a little portion of the residue in 10 ml of ethanol. Apply one drop of the solution on a filter paper, and air-dry. Drip 2C3 drops of 5% sodium nitrite and then 2C3 drops of 0.5 mol/L sulfuric acid on it. The yellow color on the filter paper disappears.
(2) To 1 g of Water-soluble Annatto, add 50 ml of water, shake, and filter. Add 2 ml of diluted hydrochloric acid (1 in 4) to the filtrate. A red-brown to yellow-brown precipitate is formed.

Purity
(1) Free alkali Dissolve 10 g of Water-soluble Annatto in 100 ml of water, shake, add 8 ml of 1 mol/L hydrochloric acid, stir thoroughly, and allow to stand for 30 minutes. The pH of the filtrate is not more than 7.0.
(2) Heavy metals Not more than 10 μg/g as Pb.
Test Solution:  Weigh 2.0 g of Water-soluble Annatto, and evaporate to dryness if necessary on a water bath.
Control Solution: Use 2.0 ml of Lead Standard Solution.
Procedure: Proceed as directed in Method 2.
(3) Arsenic Not more than 4.0 μg/g as As2O3 (Coloring Matter Tests).
(4) Absorbance ratio Proceed as directed under Identification
(1)(i). When the absorbances at the maximum absorption wavelengths around 480C484 nm and 452C456 nm are A1 and A2, respectively, A2/A1 is 1.11C1.25.

AssayWeigh accurately 0.1 to 1 g of Water-soluble Annatto, add 0.01 mol/L sodium hydroxide solution to make exactly 100 ml, and mix thoroughly. Measure exactly 1 ml of the solution, and add 0.01 mol/L sodium hydroxide solution to make exactly 100 ml. Measure the absorbance (A) of this solution at the maximum absorption wavelength of approximately 454 nm, and calculate the content of norbixin by the formula:

Content (%) of norbixin ( C24H28O4)
 A   x   100  (  x 100 ) =   3,473   weight(g) of the sample

Are there any other foreign country regulations resources available to me in the public domain?

Yes.  The USDA Foreign Agricultural Service (FAS) Global Agricultural Information Network (GAIN) online catalogues the latest GAIN reports from around the world.  You can also search by categories, countries and posts. GAIN Country reports are periodically updated and provide useful information on food regulations, government contacts and various other resources.  If your company is interested in a particular area of the globe, this is a wonderful resource to have at your fingertips.

Where can I go to get information on foreign country regulations pertaining to flavors?

FEMA members have access to an International Regulatory Resources List.  There you will find links to The FEMA GRAS Country Acceptance List, FEMA Allergen Global List and FEMA Regional Reporting Task Forces.  These documents are periodically updated so it is best to check this site for the latest and most up to date versions.  Learn more about becoming an FEMA member

Tax & Trade

Will formulas that were adopted be visible in the new TTB Formulas Online system under the current company/ownership?

Eventually, all of them.  TTB will have to manually associate the predecessor company with the current owner.  The previous database did not allow for that.  Making those changes will not be a high priority for TTB right away.

What is the difference between the role of submitter and approver in the new TTB Formulas Online system?

The roles are preparer and submitter.  The preparer can’t click the “submit” button.

How much history will be loaded from the old system to the new TTB online system and what information from the old sytem will still be available?

All of the history from the old system will be available back to late 1990 but, anything in pending status will not be visible.

The old information will not include box 13; only date received, date completed, eligible alcohol, alcohol content of finished product and new + recovered (current box #11 on form) if filled in.

Is the user manual for TTB Formulas Online available prior to go-live and/or registration?

It is currently available on the TTB website: http://www.ttb.gov/foia/fonl-docs/fonl_oim_um.pdf

Is a particular species of oak chips, Quercus sessile, allowed for use in the United States and Canada?

The United States CFR citation for oak chip is for use in alcoholic beverages only – specifically 21 CFR 172.510 - Natural flavoring substances and natural substances used in conjunction with flavors.   The CFR states: “Natural flavoring substances and natural adjuvants may be safely used in food in accordance with the following conditions. (a) They are used in the minimum quantity required to produce their intended physical or technical effect and in accordance with all the principles of good manufacturing practice. (b) In the appropriate forms (plant parts, fluid and solid extracts, concentrates, absolutes, oils, gums, balsams, resins, oleoresins, waxes, and distillates) they consist of one or more of the following, used alone or in combination with flavoring substances and adjuvants generally recognized as safe in food, previously sanctioned for such use, or regulated in any section of this part.”  Only the particular species “Oak, English, wood .... Quercus robur L ..... Do.” is listed and the limitation specifies use in alcoholic beverages only.  

In Canada, there is a short negative list (of prohibited plants) but no Canada positive list as such.  The authorities there recognize FDA, FEMA or even Council of Europe referenced materials in any company's defense of the argument that a material is "safe for human consumption" under the general terms of Canadian law.   Unable to find the "sessile" species on the FDA or CoE lists, it’s not likely allowed based on not finding any citation in the above references. The "proof" of safety would be fully in the hands of the user if challenged by CFIA or Health Canada.

Workplace Safety

Would an essential oil, such as lemon oil, be classified as a substance or a mixture under GHS?

Essential oils are natural complex substances: if you don’t have test data for those substances as such you have to consider its constituents and apply the mixture rules.

Do “not for sale” samples need labeling?

The Hazard Communication Standard currently requires hazardous samples to be labeled, and it will likely remain when HCS is rewritten to accommodate GHS.

The HCS is a right-to-know law and employees have the right to know what they are handling.  It doesn’t matter whether it’s for sale or not for sale.  If it’s hazardous by OSHA definition, it not only is required to be labeled, but it is required to have an MSDS, too.    {29 CFR 1910.1200(f)(1)}