Food & Agro-industriesCosmetics & HPCFormulationQualityProduct portfolio

How do you meet regulatory constraints while you formulate?

A banned additive, a preservative with a maximum level, a customer who only accepts EU-grown apples: a formula has to meet constraints from several sources. Checked once the recipe is frozen, they cost a trial, sometimes a batch. Checked with every change to the formula, they stop the error before it reaches production.

Three sources of constraints on one formula

A formulator works with three sets of rules that rarely sit in the same document:

  • regulations in each market you sell to: permitted food additives and their levels, allergens to declare, restricted substances and preservatives in cosmetics;
  • customer specifications: maximum salt content, required origin, refused additives;
  • your own rules: ingredients to avoid, claims targeted for the range.

These rules change. In the European Union, for example, titanium dioxide (E 171) was removed from the list of authorized food additives by Regulation (EU) 2022/63, applicable since 7 August 2022 after a six-month transition. A one-off check is therefore not enough: a recipe that complied when it was approved may not comply today.

Turn each constraint into a requirement

A constraint can be checked once it applies to data in the formula: an ingredient, an allergen, a nutrient, a physico-chemical property. You also need to state what it triggers. beCPG uses four requirement levels:

LevelEffect on the formulaExample
ForbiddenAlert as soon as the item is present, or above a maximum levelAdditives E250 and E262(i) forbidden; an ingredient forbidden above 0.2 %
ToleratedAlert without a ban, on presence or above a thresholdPreservative E252 accepted for cured meats only
AuthorizedPositive list: anything not on the list is treated as forbiddenOnly certain ingredient categories accepted in a market
InformationInformative message, no effect on complianceAvoid pepper from a given origin

In beCPG: specifications checked at every formulation

In beCPG, these rules are grouped in product specifications, the equivalent of customer requirement documents. A specification holds lists of requirements: forbidden allergens, nutrients and physico-chemical properties with a minimum or a maximum, claims, forbidden ingredients, and CLP hazard statements. For ingredients, you can also forbid GMOs, irradiation or certain geographical origins, and require an origin.

You link one or more specifications to the product in the "Specifications" field of its properties. At every formulation, beCPG compares the recipe with the requirements. An unmet requirement is shown on the line concerned, with the message you wrote, and in the product's completion wheel.

Unmet requirements of the dark chocolate éclair: sugars outside the customer specification (forbidden), fat at the limit (tolerated), a missing mandatory field
Unmet requirements after formulation: the specification message, its level and the components that cause it.

To check a formula against several markets, the "Compliance" list shows the result by country and regulatory usage. It relies on your specifications, on the beCPG regulatory module (optional) or on a connector to an external regulatory database. Our guide to checking a formula's regulatory compliance describes this approach.

Compliance list of a body lotion in beCPG: regulatory countries, usages (leave-on care for hands and body), Permitted result and Simulation state
The Compliance list: the result by country and regulatory usage.

When a raw material changes

The risk does not only come with new products. A supplier changes a raw material, a customer tightens its specification, and approved recipes stop complying. In beCPG, specifications are reformulated automatically every evening, and you can formulate a product again at any time.

Before replacing a raw material across several recipes, a change order simulates the change. The simulation lists the products whose requirements would no longer be met, for example a salt content that is too high, before you apply the replacement.

Simulated change order in beCPG: for each finished product, requirement type, simulated completion and new, resolved or less severe alerts
A simulated change order: new, resolved or less severe alerts, product by product.

A constraint written once and checked at every change is worth more than a final review. Book a demo with one of your customer specifications.

Sources

Read more: discover regulatory compliance in beCPG PLM and our post on product specification management for food and beverages.

Frequently asked questions

What is the difference between a specification and a customer requirement document?

In beCPG, they are the same object. A product specification formalizes the requirements of a customer, a market or your company, and applies to every product linked to it.

Do you have to enter all regulations by hand?

No. You can enter your own requirements in specifications, use the optional beCPG regulatory module, or a connector to an external regulatory database. The three sources can be combined.

Where do unmet requirements appear?

On the line of the list concerned, with the message from the specification, and in the product's completion wheel. The component that caused the alert is shown, so you do not have to go through the whole bill of materials.

Do these checks work for cosmetics?

Yes. Specifications also cover ingredients with a maximum level, CLP hazard statements and allergen labeling thresholds, which differ for rinse-off and leave-on products.

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