Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients That Are Color Additives; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives.” The guidance explains FDA's current thinking on the factors to be considered when determining whether changes in manufacturing process, including the intentional reduction in particle size to the nanoscale, for a food substance already in the market affect the identity of the food substance, impact the safety of the use of the food substance, change the regulatory status of the use of the food substance, or warrant a new regulatory submission to FDA.

DATES:

Submit either electronic or written comments on FDA guidances at any time.

ADDRESSES:

Submit written requests for single copies of the guidance entitled “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives” to the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy, College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance.

Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Teresa Croce, Center for Food and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1281.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a guidance entitled “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives.” The guidance is being issued consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of applicable statutes and regulations. This guidance represents FDA's current thinking on the factors to be considered when determining whether changes in manufacturing process, including the intentional reduction in particle size to the nanoscale, for a food substance already in the market affect identity of the food substance, impact the safety of the use of the food substance, change the regulatory status of the use of the food substance, or warrant a new regulatory submission to FDA.

In the Federal Register of April 25, 2012 (77 FR 24722), we made available a draft guidance entitled “Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives” and gave interested parties an opportunity to submit comments by July 24, 2012, for us to consider before beginning work on the final version of the guidance. We received several comments on the draft guidance and have modified the final guidance where appropriate. The guidance announced in this notice finalizes the draft guidance dated April 2012.

II. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in §§ 170.101, 170.106, and 171.1 have been approved under OMB control number 0910-0495; the collections of information in §§ 70.25, 71.1, 170.35, and 171.1 have been approved under OMB control number 0910-0016; the collections of information in § 170.39 have been approved under OMB control number 0910-0298; and the collections of information in proposed § 170.36 (62 FR 18938, April 17, 1997) has been approved under OMB control number 0910-0342.

III. Comments

Interested persons may submit either written comments regarding the guidance to the Division of Dockets Management (see ADDRESSES) or electronic comments regarding the guidance to http://www.regulations.gov. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/FoodGuidances or at http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance.