New P statements in the CLP Regulation: the classification stays, the safety data sheet changes

The new P statements are a change in the draft CLP amendment that almost every company working with chemicals will feel. For a large share of products, the classification will probably not change. Even so, the safety data sheet and the label will have to change, precisely because of the precautionary statements.

This is the second article in a series on aligning the CLP Regulation with revisions 8, 9 and 10 of the GHS. In the first part we gave an overview of the draft and the deadlines. Today we look at P statements: the most important changes, with examples, and their consequences for your documents.

Why the precautionary statements are being rewritten

GHS revisions rationalize the precautionary statements. According to the draft’s explanatory memorandum, the aim is for users to understand them better. At the same time, attention is paid to how practical they are for those who prepare labels.

The changes are therefore extensive. Even the title of Annex IV to the CLP Regulation changes, along with its entire introductory part. The draft deletes a number of statements, introduces new ones and changes the wording or conditions of use for dozens of existing ones.

The most important changes, with examples

The most visible change concerns medical help. Statements P310 to P315 are deleted. In their place come four new ones, graded by urgency.

Code	Text (draft, EN)	Example hazard classes
P316	Get emergency medical help immediately.	acute toxicity cat. 1 to 3, skin corrosion
P317	Get medical help.	acute toxicity cat. 4, skin and eye irritation
P318	IF exposed or concerned, get medical advice.	mutagenicity, carcinogenicity, reproductive toxicity
P319	Get medical help if you feel unwell.	STOT SE cat. 3, STOT RE

Deleting the base statements also changes the combinations. So P301 + P310 becomes P301 + P316, and P337 + P313 becomes P337 + P317. The combination P308 + P313 is deleted without a replacement.

The second example is the general warnings. Statements P201 and P202 are deleted. A single statement, P203, replaces them for explosives, chemically unstable gases and the CMR hazard classes.

The third example is corrosive products. For skin corrosion, a new statement P354 is introduced, along with the new combinations P302 + P361 + P354 and P305 + P354 + P338. So for such mixtures almost the entire set of statements changes, not just the medical help statement.

New rules for medical help

The draft also introduces rules for cases where more than one medical help statement is triggered. When different routes of exposure trigger different statements, all of them are listed.

For the same route of exposure, a priority order applies. P316 takes precedence over P317, and P317 over P319. P318, however, is always listed when it applies.

That is why, for products with several hazard classes, it is not only the code that changes. The number and order of statements on the safety data sheet and the label may change too.

The classification stays, the safety data sheet changes

This is the core of this part of the series. For a large share of products, the changes will probably not alter the classification. Acute toxicity, eye irritation or carcinogenicity stay the same. Even so, the set of P statements that goes with those hazard classes changes.

Besides the medical help statements, the draft changes the wording or conditions of use for a range of other statements. Among them are P210, P260, P261, P264, P270, P271 and P280. These are statements found on a large share of labels.

The consequence is simple. The safety data sheet has to be amended even when the product’s hazard has not changed but the precautionary measures have. The same goes for the label.

The workload over the next four years

Under the draft, the new rules become mandatory 24 months after entry into force. Products already on the market have 48 months to comply. In other words, within four years a large share of the safety data sheets on the EU market will have to be revised.

For a single company, that means every product, every language and every label. For example, a distributor with 400 products in three languages has 1,200 safety data sheets to check. On top of that, printed packaging has to be brought into line as well.

This wave of revisions will hit manufacturers, downstream users, importers, distributors and consultants all at once. Whoever starts last will be waiting on everyone: on suppliers, on the print shop and on the experts.

Digitalization as a way through the transition

With changes like these, the way you manage your safety data sheets becomes decisive. If every document is a separate Word file, replacing P statements means opening each file one by one. Along the way it is easy to miss a combination or a language version.

A digital system with structured data works differently. When P statements are derived from the classification, it is the assignment rule that changes, not each document individually. A search by code immediately shows which documents are affected. Also, the translation of a new phrase is entered into the system and becomes available everywhere.

Then there is the consistency between the label and the safety data sheet. When both documents draw on the same data source, it cannot happen that one is changed and the other is not.

That is why the period until mandatory application is a good moment to decide. The transition can be done manually, document by document, or systematically, through digitalization.

Translations and the situation in Serbia

For now, only the English texts of the new statements are filled in in the draft. The fields for the other EU languages are still empty. So the official translations will come only with the final text of the regulation.

In Serbia, the Serbian texts will be set only when the changes are transposed into the national rulebook. Until then, the new statements have no official Serbian wording. Even so, exporters to the EU and importers from the EU will encounter them much sooner.

Frequently asked questions

Which P statements are deleted by the CLP amendment? P201, P202 and P310 to P315 are deleted, as is the combination P308 + P313. All combinations that contain the deleted statements change as well.

What replaces P310? P310 is replaced by P316: “Get emergency medical help immediately.” The combination P301 + P310 becomes P301 + P316.

Do I have to change the safety data sheet if the classification has not changed? Yes, if the safety data sheet contains statements that are deleted or changed. That will be the case for a large share of existing safety data sheets.

How much time do I have to amend my safety data sheets? Under the draft, the new P statements become mandatory 24 months after the regulation enters into force. Products placed on the market before that date may remain on the market until 48 months have passed.

Are there official Serbian translations of the new P statements? No. The draft contains only the English texts. The Serbian texts will be set by an amendment to the national rulebook.

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This blog post is for informational purposes only and does not constitute legal advice. For specific situations, consult a licensed chemical adviser or a lawyer specialising in chemical regulation.