Category: Circular

FDA Memorandum Circular No. 2019-008 || REMOVAL OF AUTHENTICATION OF FOREIGN PUBLIC DOCUMENTS EXECUTED IN APOSTILLE-CONTRACTING COUNTRIES AND TERRITORIES BY THE PHILIPPINE EMBASSIES OR CONSULATES GENERAL BEGINNING 14 MAY 2019

In connection with the Department of Foreign Affairs (DFA) Public Advisory dated 07 May 2019 Re: Apostille Convention on Authentication of Documents Takes Effect in PH on 14 May 2019, all concerned stakeholders are hereby notified that foreign public documents executed in Apostille-contracting countries and territories (with the exception of Austria, Finland, Germany and Greece, all of which objected to the accession of the Philippines to the Apostille Convention) no longer have to be authenticated by the appropriate Philippine Embassy or Consulate General once they have been Apostillized in order to be recognized and accepted in the Philippines.

An Apostille is a document used in international law that is issued by a government in accordance with the Hague Convention Abolishing the Requirement of Legalization for Foreign Public Documents (otherwise known as the Hague Apostille Convention or simply the Apostille Convention). It is attached to a public document to certify the authenticity of the signature, the capacity in which the person signing the document has acted, and where appropriate, the identity of the seal or stamp which it bears.

Relative to certain documents submitted to the Food and Drug Administration presently requiring “authentication by the territorial Philippine Consulate” (e.g. Certificate of Free Sale, as per A.O. No. 67 s. 1989 and B.C. No. 5 s. 1997), this Office shall begin accepting such documents bearing an Apostille in lieu of the traditional red ribbon.

However, for countries and territories which are not Apostille-contracting parties, the requirement of authentication of foreign public documents by the appropriate Philippine Embassy or Consulate General shall still apply.

For reference purposes, the updated list of Apostille-contracting parties can be accessed using the following link: https://www.hcch.net/en/instruments/conventions/status-table/?cid=41.

Please be guided accordingly.

Attachment:-> FMC2019-008

/ In Circular / By Administrator / Comments Off on FDA Memorandum Circular No. 2019-008 || REMOVAL OF AUTHENTICATION OF FOREIGN PUBLIC DOCUMENTS EXECUTED IN APOSTILLE-CONTRACTING COUNTRIES AND TERRITORIES BY THE PHILIPPINE EMBASSIES OR CONSULATES GENERAL BEGINNING 14 MAY 2019

FDA Circular No. 2019-006 || GUIDELINES IN COMMERCIAL DISPLAY, SELLING, PROMOTION, AND ADVERTISING OF ALCOHOLIC BEVERAGES AND BEVERAGES THAT CONTAIN ALCOHOL

Pursuant to Article II, Section 15 of the 1987 Philippine Constitution to protect the right to health of the people and instill health consciousness among them; and in Section 15 (2), Chapter 4, Title IX, Book IV of the Administrative Code of 1987 authorizes the Food and Drug Administration (FDA) to act as the policy formulation and sector monitoring arm of the Secretary of Health on matters pertaining to food, drugs, traditional medicines, cosmetics and household products containing hazardous substances, and to formulate rules and regulations and standards in accordance with the FDA mandate in accordance with Republic Act No. 3720 as amended by Executive Order No. 175 and further amended by Republic Act No. 9711, and other allied laws for their proper and effective enforcement, this regulation is hereby promulgated for the information and compliance of all concerned.

Furthermore, Article III Section 5(f) on Food Safety Requirements under Republic Act No. 10611 or the Food Safety Act of 2013, states that “compliance of a food product with specific standards applicable to a specific food shall not prohibit the competent authorities to take appropriate measures or to impose restrictions on entry into the market or to require its withdrawal from the market, where there is reason to suspect that such food product shows food safety-related risks.”

Food packaging technology and market innovation concerning stand-up pouch, flexible, tetra pack and similar packaging materials are now evolving in both the international and local market, hence the FDA sets the following guidelines to protect the consumers, especially children:

  1. All alcoholic beverages, regardless of type of packaging, shall only be displayed in designated conspicuous area in all convenience stores, supermarkets, hypermarkets, groceries and other food retailing stores with prominent signage “ALCOHOLIC BEVERAGES.” Other beverages with alcohol regardless of level of alcohol content like alcopop (flavoured beverage with alcohol content) shall likewise be displayed in this same designated area. These beverages shall not bedisplayed together with other products like juice drinks and MUST NOT be accessible to children;
  2. Owners or operators of sari-sari stores which may not have enough space to designate an area for alcoholic beverages and other beverages with alcohol content shall be responsible to ensure that subject beverages as mentioned in Item no. 2 above are not sold to minors (below 18 years old); and
  3. Promotional and advertising materials on alcoholic beverages and beverages with alcohol content (regardless of amount) shall clearly state or inform consumers that such beverages contain alcohol, and therefore not to be promoted and advertised to be sold to and consumed by minors. Packaging and labelling materials shall not be appealing to children.Sanctions and penalties over violations of any of the provisions of this FDA Circular shall follow the Rules of Republic Act No. 10611 and its IRR, otherwise known as the Food Safety Act of 2013.The FDA is enjoining all concerned, including local government units having jurisdiction on sari-sari stores, convenience stores, groceries, hypermarkets, supermarkets and other similar food retailing stores to strictly implement these guidelines.

    This Circular shall take effect immediately.

    Attachment-> :  FDA Circular No. 2019-006

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2019-006 || GUIDELINES IN COMMERCIAL DISPLAY, SELLING, PROMOTION, AND ADVERTISING OF ALCOHOLIC BEVERAGES AND BEVERAGES THAT CONTAIN ALCOHOL

FDA Circular No. 2019-005 || Updates and Amendments of the ASEAN Cosmetic Directive (ACD) as Adopted During the 30th ASEAN Cosmetic Commitee (ACC) Meeting and Its Related Meetings

to continue reading, click the attachment below…

Attachment-> : FDA Circular No.2019-005

/ In Circular / By Administrator / Comments Off on FDA Circular No. 2019-005 || Updates and Amendments of the ASEAN Cosmetic Directive (ACD) as Adopted During the 30th ASEAN Cosmetic Commitee (ACC) Meeting and Its Related Meetings

FDA Circular No.2019-004 || Ban of Bisphenol A (BPA) from Infant Feeding Bottles and Sippy Cups as Child Care Article Products

I. RATIONALE

Consistent with the 1987 Philippine Constitution as a declared policy of the State to protect and promote the right to health of the Filipino people and instill health consciousness among them, Republic Act (RA) No. 9711, otherwise known as the “Food and Drug Administration (FDA) Act of 2009”, and its Implementing Rules and Regulations, the FDA hereby imposes a ban on Bisphenol A (BPA) in infant feeding bottles and sippy cups as child care article products.

II. SCOPE

This Circular shall cover infant feeding bottles and sippy cups as child care article products containing BPA and the establishments that are engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, and where applicable, the use, testing, promotion, advertising, or sponsorship of any child care articles containing BPA.

III. GENERAL INFORMATION

Bisphenol A (BPA) is an industrial chemical that is widely used as a monomer in the manufacture of polycarbonate (PC); a clear, hard plastic used in many consumer products including feeding bottles and sippy cups. Relevant epidemiological studies have shown that BPA affect the development of the nervous, immune and reproductive system and considered as endocrine disruptors which can alter the hormonal system of the human body. Extensive use of BPA in manufacturing products that come in contact with food increases the risk of exposure to this compound, mainly through the digestive tract.

Over the years, concerns have been raised about BPA’s effect on human health, especially when it is used in food contact materials (FCM) and articles such as feeding bottles and sippy cups. In 2008, Canada first proposed the prohibition of polycarbonate baby bottles that contains BPA which came into force in 2010. And in 2011, the European Union (EU) along with China are among the countries which banned the manufacture including the importation of PC baby bottles with BPA.

In the Joint Food and Agriculture Organization and World Health Organization (FAO/WHO) Expert Meeting held on November 2010, the toxicological and health aspects of BPA was reviewed. The expert panels concluded that dietary exposure estimates are generally higher for infants (0-6 months) fed using PC baby bottles with the mean of 2.4 pg/kg body weight per day. This is due to migration of BPA from PC baby bottles when filling the bottle with boiling water, adding milk formula and leaving the bottle to cool down.

Thus, this Circular is issued by the FDA to better protect the health of the children and better reduce exposure to these substances.

IV. POLICIES AND GUIDELINES

  1. The manufacture, importation and distribution of infant feeding bottle and sippy cups containing Bisphenol A (BPA) shall not be allowed.
  2. All concerned establishments shall be given six (6) months phase-out period to recall from the market all infant feeding bottles and sippy cups containing BPA.
  3. It shall be the responsibility of the manufacturer, trader, importer, distributor or wholesaler to conduct recall of their products to ensure that infant feeding bottles and sippy cups containing BPA, are removed from the market and shall no longer be made available to the market after the phase-out period.
  4. The manufacturer, importer and/or distributor of the banned products shall conduct inventory and submit a report to the FDA one (1) month after the given phase-out period.
  5. The manufacturer, importer and/or distributor of the banned products shall prepare a disposal plan in accordance with Department of Environment and Natural Resources- Environmental Management Bureau (DENR-EMB) rules and regulation subject to FDA approval.

V. PENALTY CLAUSE

Any establishment found to be in violation of the provisions of this issuance shall be subjected to sanctions and penalties as prescribed under RA 9711 and its IRR.

VI. EFFECTIVITY

This Circular shall take effect thirty (30) days after publication in two (2) newspapers of general circulation and submission of a copy hereof to the Office of the National Registry of the University of the Philippines Law Center.

Attachment-> : FDA Circular No.2019-004

/ In Circular / By Administrator / Comments Off on FDA Circular No.2019-004 || Ban of Bisphenol A (BPA) from Infant Feeding Bottles and Sippy Cups as Child Care Article Products

FDA Circular No.2012-007-A || Amending FDA Circular No. 2012-007: Reduction of Turn-Around-Time for the Regulatory Review of Clinical Trials and Revised Procedure for the Application of Import License for Investigational Products

to continue reading, click the attachment below…

FDA Circular No.2012-007-A

/ In Circular / By Administrator / Comments Off on FDA Circular No.2012-007-A || Amending FDA Circular No. 2012-007: Reduction of Turn-Around-Time for the Regulatory Review of Clinical Trials and Revised Procedure for the Application of Import License for Investigational Products

FDA Circular No. 2018-009 || Updates and Amendments of the ASEAN Cosmetic Directives (ACD) as Adopted During the 28th ASEAN Cosmetic Committee (ACC) Meetings and Its Related Meetings

I. Background and Rationale

In 2005, the Department of Health (DOH) – Food and Drug Adminstration (FDA), then called Bureau of Food and Drugs (BFAD), has adopted and implemented the ASEAN Harmonized Cosmetic Regulatory Scheme and the ASEN Common Technical Documents through Administrative Orders No. 2005-0015 and 2005-0025, respectively. The harmonization scheme involves the conduct of alignment meetings for the purpose of eliminating trade barriers and enhancing cooperation within the ASEAN Members States (AMS) in ensuring the safety, quality and claimed benefits of cosmetic products.

FDA Circular No. 2018-009

/ In Circular / By FDA_Admin2 / Comments Off on FDA Circular No. 2018-009 || Updates and Amendments of the ASEAN Cosmetic Directives (ACD) as Adopted During the 28th ASEAN Cosmetic Committee (ACC) Meetings and Its Related Meetings