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Harmonization and Labeling

October 13, 2016

This article is not to be confused with the Global Harmonized System of Classification and Labeling of Chemicals (GHS) standards, also called CLP in the EU whose main purpose is to communicate hazards on product labels and safety data sheets.

In general the principals of harmonization are the same, i.e. to ‘make one’ or create a common framework, whether it be for labeling or for other purposes. Harmonization brings Clarity, Consistency, Confidence and Compliance. Imagine if all countries follow the same regulatory labeling guideline, the savings in cost would be significant. It was with this same intent that CODEXwas established by the WHO way back in 1963 with the intent of developing food standards, codes of practice, guidelines and other recommendations which can be adopted by all member countries. Even though CODEX is still active, Codex standards and related texts are voluntary and member countries are not bound by or required to adopt them. Many countries who are just beginning to put their regulatory frameworks together, end up adopting the regulatory framework of their largest trading partner to ease trade (foreign partner does not have to change labels to sell locally). Many countries have adopted the US FDA regulatory framework as a model for their own country. These are examples of harmonization at the regulatory level and country level.

Extending the same principals to the company level, global organizations with operations and sales in many countries implement a continuous process of harmonization. By understanding the regulatory requirements of different countries, organizations have been able to make a single common label which meets the regulatory requirements of multiple countries or markets. Designing, approving and printing one label as opposed to separate country specific labels is far more efficient and cost effective.


However, this is easier said than done, because the regulatory teams handling the respective countries have to decide on the common text that has to be present on the artwork. Sometimes, it may be possible to combine the secondary packaging artwork text, but not the primary packaging text. In the Pharmaceutical industry, the package inserts are most often combined for multiple markets, while keeping the other component labels the same. This by itself is a big saving in terms of time and effort.

Harmonization changes in labeling also require the packaging BOM to be changed to reflect common Item Codes or Artwork Codes for the combined label across all the affected SKUs.

Harmonization is not a one-time thing and as regulations change, it requires constant effort to make sure the ‘harmonized label’ continues to comply by the regulations of the intended market. Even though adjacent countries or markets have similar regulatory frameworks, the changes to these regulations do not happen at the same time. So it’s not uncommon to use the maximum regulatory requirement of all countries related to the ‘harmonized label’ even though some countries may not require it.

The entire process of harmonization can be managed relatively easily if the text change is part of a planned labeling change. However it becomes difficult if there is an immediate labeling change initiated due to regulatory or other internal reasons.

Thinking about harmonization should start early in the artwork life cycle i.e., from draft submission to the regulatory agencies. If the regulations are the same or similar, the organization can save time by using a previously available submission artwork.


 Areas of Harmonization

Typical areas of label harmonization include

  • having multiple languages in the same label or artwork to satisfy different market requirements
  • using multiple Units of Measurement (UoM), metric and non-metric in the same label. E.g. grams (oz)
  • combining based on pack size, e.g. having a single packaging insert for the 20 tablets, 50 tablets and 100 tablets pack
  • using globally accepted naming conventions, e.g. for Ingredient Names
    • identifying botanicals only by their Latin names
    • identifying color additives only by the “CI” numbers used in the European Union
    • using terms from other languages, such as “Aqua” and “Parfum” instead of “Water” and “Fragrance.”

Common practice is to use both names with one in paranthesis

  • Water (Aqua)
  • Fragrance (Parfum)
  • Honey (Mel)
  • Sweet Almond (Prunus Amygdalus Dulcis) Oil
  • FD&C Yellow No. 5 (CI 19140)
  • same claims in different markets. Companies need to be careful when doing this because of the diverse interpretation of words in each market. E.g.
    • “Nutrition” in Pakistan was understood as “rich, meaty, fatty  food”  whereas  in  Thailand  it  connoted  “pasteurized  no  preservatives”.
    • “Healthy” in  Philippines  was  understood  as  “a  man  in  a  Hawaiian  shirt”,  but  in Singapore it implied “going to run everyday”.
    • “Fortified” in Korea connoted “strong and robust” but Chinese understood this as “there must be something wrong with it in the first place”

Harmonization is an on-going process and each organization needs to do its own cost-benefit analysis before attempting it.

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