Hi Anon.
"Officially", the OTC product must comply with the EU regulations at this point in the UK including any registration requirements. However, several important caveats:
1. Several of the OTC categories in the US are actually regulated as cosmetics in the EU. As an example, the OTC sunscreens in the US are regulated under the cosmetics regulations in the EU so would need to be relabeled to avoid problems at the border on importing.
2. BREXIT is real and it is coming. At this point, barring a serious miracle and additional legislation from the UK Parliament (which will require Prime Minister agreement as well since the PM is the head of the UK government) this is going to occur on 1 Jan 2021. The only way this changes is if the UK specifically requests that the EU extend the agreement for a longer transition time where the UK remains part of the EU. However, the UK government has repeatedly stated that they have no intention to ask for additional time in the EU. This request would need to come to the EU by the end of June and the EU has stated that they would be open to an extension but the current Treaty requires that the country who activated the Article 50 proceedings needs to make that request.
3. With BREXIT there will be a separate requirement in the UK likely on 1 Jan 2021. While this might look effectively the same as the EU, the fact is that where a Responsible Party (e.g., for sunscreens) is required, the EU-based responsible party is not going to be acceptable in the UK. Think about it - the UK wants to be able to get at the responsible party in order to enforce any requirements. So you will likely need to consider this potential issue as well.
4. Remember that you may be required to comply with the requirements of the UK's equivalent to the REACH regulation in the EU likely depending on the amount of each individual chemical that is imported into the EU in any particular year. REACH currently has a 1 metric ton trigger but I haven't seen/heard whether this is going to be changed in the UK. If you trip over the trigger level you will need to register every chemical for which you trip over the trigger level with the UK. This is also going to require that you break down every single product you ship to the UK to its CAS number parts, determine how much of each CAS number is in each product, determine how much product is shipped to the UK, calculate amount of each CAS based on the products and then total the amount of each CAS being imported into the UK on behalf of your company through the importer(s) of record. So this gets fun really quickly.
So you really need to understand the EU/UK regulations to determine what needs to happen in relation to the US OTC items. Also, remember that you generally are going to need someone's business or name on the label that is within the UK to ensure that you can legally import the product(s) into the UK otherwise you have an issue with any import tariff and more importantly any regulatory issues. So be really careful about this if you are planning to go that route. Please feel free to reach out for further specific questions!
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Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
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Original Message:
Sent: 17-Jun-2020 21:12
From: Anonymous Member
Subject: US OTC Product sold on Amazon UK
This message was posted by a user wishing to remain anonymous
Does anyone have experience with selling OTC products on Amazon? I'm wondering how US labeled OTC products are sold on Amazon UK. Does the product need to be registered in the UK? Labeled for that market? From some products I see it looks just like US product so I'm wondering how that is done.
Thank you!