Food labels: Department of Health approval, language and permit number

It is Rule 4.3.7 of Chapter 4.3 of Joint Regulation No. 9473, the Health Licence chapter, devoted to food for human consumption. It has five short sections: ice-cream industry products and frozen desserts, food labelling, sampling, nutritional qualities, and good manufacturing, packing and storage practices. It is the chapter’s briefest rule and, in good part, a map of references: it adopts federal and state standards and adds its own label requirements on top.

Labelling applies to every food manufactured or packed in Puerto Rico and imported. The language requirement — Spanish or bilingual format — the rule directs at the labelling of products made or processed and marketed in Puerto Rico. The good manufacturing practices of Title 21 Part 110 apply to every public establishment, as defined in the regulation, where food for human consumption is manufactured, packed or stored. And sampling applies to that required by this regulation or any other regulation or law, state or federal.

• Obtaining the Department of Health’s approval for the label or labelling before the applicant uses it.Verified against the official source
• Labelling in Spanish or in bilingual format, English and Spanish, the products made or processed and marketed in Puerto Rico.Verified against the official source
• Printing on the label or labelling the Permiso Único number or the Health Licence number, together with the lot number or the production date.Verified against the official source
• Printing any other information the Secretary of Health deems pertinent to require on the label.Verified against the official source
• Conforming the label to Title 21 Part 101 of the Code of Federal Regulations and to Act No. 72 of 26 April 1940, without relying on the exemptions granted in Part 101.9 of Title 21, which will not apply in Puerto Rico.Verified against the official source
• If food for human consumption is manufactured, packed or stored: complying with the provisions of Title 21 Part 110 of the Code of Federal Regulations, as amended.Verified against the official source

• The proposed label or labelling, for the Department of Health’s approval before using it.
• The establishment’s Permiso Único or Health Licence number, which must appear printed on the label.

1. 1

   Step 1: The label is approved before it is used

   It is the requirement that most surprises anyone about to bring a product to market: the label or labelling must be approved by the Department of Health before the applicant uses it. It is not a later formality or an inspection: the approval comes before use. It is worth counting into the launch calendar, because the regulation publishes no term for the Department to decide.

2. 2

   Step 2: The language: Spanish or bilingual

   The rule is specific about which products it applies to: the labelling of products made or processed and marketed in Puerto Rico must be in the Spanish language or in bilingual format, English and Spanish. It does not say Spanish is optional or that English alone will do; the two alternatives it offers are Spanish only, or English and Spanish together.

3. 3

   Step 3: What goes printed: the permit number and the lot

   The Permiso Único number or the Health Licence number must be printed on the label or labelling, as must the lot number or the production date. And the rule leaves the door open to more: the Secretary of Health may require any other information he deems pertinent to be printed on the label. That is: the regulation sets the minimum content, but it is not a closed content.

4. 4

   Step 4: The federal basis, and the exemption that does not apply here

   Every food manufactured or packed in Puerto Rico and imported will be labelled, and its label will conform to Title 21 Part 101 of the Code of Federal Regulations, as amended, and to Act No. 72 of 26 April 1940, known as the Puerto Rico Food, Drug and Cosmetics Act, as amended. And here comes the part not to overlook: the regulation expressly provides that the exemptions granted in Title 21, Part 101.9 will not apply in Puerto Rico. A note on the source: that citation is printed with a brace instead of a parenthesis and with a typo in the word "aplicables"; we publish what the sentence unambiguously provides and report the citation as it appears, without reconstructing a federal reference we have not read.

5. 5

   Step 5: Who takes the samples

   Section 4.3.7.3 is a single sentence and answers a question that comes up often: the taking of food samples required by this regulation or by any other regulation or law, state or federal, will be carried out by the Department of Health and in accordance with the Department’s own regulations in force.

6. 6

   Step 6: Nutritional qualities and good practices

   Two further sections adopt federal standards by reference. The requirements and guides on the nutritional qualities of food for human consumption of Title 21, Parts 104 and 137 of the Code of Federal Regulations, as amended, will be applied as a standard. And to every public establishment, as defined in the regulation, where food for human consumption is manufactured, packed or stored, the provisions of Title 21 Part 110 of the CFR, as amended, will apply, which are the good practices of manufacture, packing and storage.

7. 7

   Step 7: Ice cream and frozen desserts

   The rule’s first section has its own addressee. Products of the ice-cream industry and frozen desserts, as defined in 21 CFR 135.3, will be regulated in that section in accordance with the US Food and Drug Administration’s recommendations included in the Guide for the Processing of Frozen Desserts, as revised, and with Title 21 Part 135 of the CFR, as amended. It is a complete referral: whoever makes ice cream in Puerto Rico looks for their product rules in those federal documents.

8. 8

   Step 8: What this guide cannot tell you

   It is worth being explicit about the limit. Rule 4.3.7 is, to a good extent, a map of references, and we have read none of the documents it points to: not 21 CFR 135.3 and Part 135, not the FDA’s Guide for the Processing of Frozen Desserts, not Part 101 with its Section 101.9, not Parts 104 and 137, not Part 110, not Act No. 72 of 1940, and not the Department of Health’s sampling regulations. We publish what the rule itself says, name every document it sends readers to, and publish nothing about their content. If your product needs to know what Part 101 requires about a specific declaration, that answer is in Part 101, not here.

The label’s approval comes from the Department of Health, and food sampling is also carried out by the Department of Health under its own regulations. The number printed on the label is the establishment’s Permiso Único or Health Licence number, which are processed before OGPe. The regulation publishes no fee for the label’s approval and no term for deciding it.

• Sending the label to print before the Department of Health approves it.
• Labelling only in English a product made or processed and marketed in Puerto Rico.
• Omitting from the label the Permiso Único or the Health Licence number.
• Omitting the lot number or the production date.
• Relying on the exemptions in Part 101.9 of Title 21, which the regulation declares not applicable in Puerto Rico.
• Assuming that meeting the federal labelling standard is enough, without the regulation’s two additional requirements.
• Changing an already approved product’s label without going through approval again.
• Overlooking that the Secretary of Health may require any other information he deems pertinent on the label.
• Believing another agency takes the food samples: the Department of Health carries them out.
• Making ice cream or frozen desserts without turning to the FDA’s guide and Title 21 Part 135, which the rule adopts by reference.
• Manufacturing, packing or storing food without attending to Title 21 Part 110 on good practices.

These are the government pages this guide is based on.

• Oficina de Gerencia de Permisos (OGPe)

  OGPe

  docs.pr.gov

• Department of Health

  salud

  www.salud.pr.gov

• Permit Management Office

  ogpe

  ogpe.pr.gov