Every so often a piece of guidance appears that does not change the law as such but changes how everyone has been reading it, and the 2022 revision of the Blue Guide is one of those. For those of us working in cosmetic regulatory compliance it is worth pausing over, because it tidies up a point that the industry had, for years, been interpreting rather generously in its own favour.
The point in question is the meaning of “placing on the market”. When the rules change, whether through a new restriction in an annex or an addition to the allergen labelling requirements, a transition period is normally granted. Products already on the market may continue to be supplied for a time while the new stock is brought into line. The whole question is what counts as being on the market at the point the rules change, and here the old habit and the new clarity part company.
The comfortable interpretation, and the one a great many companies quietly relied upon, was that placing on the market meant launching a product as a new line. On that reading a formulation that already existed was an established product, not something being placed on the market afresh, and so a business could carry on making and supplying it right up to the very end of the transition period. It was a convenient reading because it extended the breathing space considerably and asked very little of anyone in the meantime.
The Blue Guide closes that door. It makes clear that placing on the market refers to the first time an individual product, meaning an individual physical unit, is made available on the Union market. It happens once per item, and it attaches to the manufacturer or importer. Making available, by contrast, is any subsequent supply of that unit down the distribution chain. The distinction matters enormously, because it means the transition period protects the units that were genuinely placed on the market before the deadline. It does not license the continued manufacture of fresh, non-compliant units of an existing formulation simply because that formulation had been around for a while.
Put plainly, an old recipe does not buy you an extension. Each new jar coming off the line after the deadline is a new act of placing on the market and must meet the current rules. What the transition period does buy is time for stock already made and already supplied to work its way through wholesalers and retailers to the consumer. That sell-through, the making available of units already placed on the market, is the thing the transition is really there to accommodate.
The practical implication for anyone reformulating in response to a regulatory change is that the clock is less forgiving than it used to appear. You cannot keep producing to the old specification until the final date and treat everything as covered. Production needs to switch to the compliant version by the point at which new units are placed on the market, and only genuinely pre-existing stock enjoys the run-off period after that.
None of this is a reason for alarm, but it is a reason to plan properly. If you are working through a change to the annexes and trying to judge how long you really have, the honest answer is that it depends on distinguishing the units you have already placed on the market from the ones you have yet to make, and treating the two quite differently. If that is a distinction you would welcome some help drawing for your own product range, it is precisely the sort of thing we spend our days on, and we would be glad to hear from you.
European Commission, Commission notice — The ‘Blue Guide’ on the implementation of EU product rules 2022 (2022/C 247/01), Official Journal of the European Union, C 247, 29 June 2022, pp. 1–156.
