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Life Sciences Alert – April 2019

ALERT – LIFE SCIENCES

1. Filing label in the food sanitary registry in the General Environmental Health Agency (DIGESA) is eliminated.

By virtue of Minister’s Order No. 250-2019/MINSA published on March 19, 2019, the Consolidated Text of Administrative Procedures (TUPA) of the Ministry of Health is amended, including changes in the requirements to industrialized food sanitary registry in DIGESA.

The amendment eliminates the requirement from the product label proposal being replaced by an affidavit ensuring that the product label complies with all regulatory information pursuant to Section 117 of the Supreme Executive Order No. 007-98-SA.

Therefore, from March 20, 2019, the product label proposal should not be attached to requests for industrialized food sanitary registry, but only an affidavit as indicated in the table above.

2. DIET PRODUCTS AND SWEETENERS WOULD BE SUPERVISED BY DIGESA

The Health and Population Commission of the Peruvian Congress approved unanimously the Bill No. 1717-2016-CR that proposes to amend Act No. 29459 under the followings terms:

  • Eliminate diet products and sweeteners from the pharmaceutical products classification and exclude them from the supervision of the General Medicine, Supplies and Drug Administration (DIGEMID).
  • Diet products and sweeteners will be supervised by the Environmental Health and Food Safety Division of DIGESA.

The aforementioned bill must be discussed and put to the vote in Plenary Session of the Congress. There is still no estimated date for the review of said bill to be included in the agenda of the Plenary Session. It should be mentioned that the act will not come into effect until its approval and publication in the Official Gazette “El Peruano”.

3.USING FOOD LABELS IN STOCK UP

DIGESA approved the “technical criteria to authorize the use of labels in stock for national industrialized food” by virtue of Director’s Order No. 067-2018/DIGESA/SA.

The regulation of industrialized food sanitary registry (Supreme Executive Order No. 007-98-SA) establishes that the products must be sold having certain regulatory information in the label referred to registry holder’s details and other health aspects of the product (i.e., list of ingredients, manufacturer, expiry date, etc.)

DIGESA recognizes that said information is subject to amendments or changes during the effective period of the registry (5 years). Changes may include amendments to the information contained in the label that not represent significant variations altering sanitary aspects of the registered product.

Therefore, upon a constantly changing reality of food label information, DIGESA considered necessary to approve the technical criteria to authorize the use of labels subject to changes, including an adhesive or a printout containing the updated information for a term of 1 year.

For further details, please contact Maritza Reátegui (mreategui@estudiorodrigo.com) and/or Solange Noriega (snoriega@estudiorodrigo.com ).