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.