If you want your game in the EU you’ll likely need all of the above. It’s a fair amount of work but very doable once you understand it.

I got really frustrated when searching for clear answers on how to ship a board game into the EU/UK. I found a lot of misinformation, “experts” that didn’t care to link any sources, and a seemingly never ending amount of stones to overturn. After searching high and low, it appears the reason for this is that no one has ever written down all the requirements to ship a game to the EU/UK in on place.

So that is what I am aiming to do here.

While I’m not going to call myself an expert in the EU/UK import law, I do have some experience digesting complex standards. My day job is with a global medical device manufacturer, and in a previous engineering role I was responsible for digesting safety and performance standards for electro-mechnical medical devices, as well as coordinating the documentation for international registrations. So I know first hand how tricky this landscape can be. Which is why I decided rather than base my game’s labeling and documentation off questionable forum threads, it would be best for me to just get the requirements directly from the source – the standards.

This article should be your one-stop, source-linked guide for everything you need to ship your product into the EU/UK. And I won’t ask you to just trust me. No, I’ll link all the official documents and share my rationales so you can check my work and be best informed when it comes to your own game.

If you’re looking for a summary here it is, you need

a CE mark on your game (probably),
an EU/UK Authorized Representative (probably),
and, a way to handle VAT (probably through a fulfillment partner).

I say probably because everything here is case dependent, which is why you can’t trust any advice that simply says “this is the one and only answer.” But if all you want is the requirements, skip to the end of the three sections for summaries of what is needed – though I would highly recommend you familiarizing yourself with the “why” behind each requirement. I know that for me it was extremely helpful for me to feel more confident with this side of the business.

Now buckle up, we’ve got some standards to dive into, starting with the big one – the CE mark.

Because the Vivid Vision system is a Class 1 Medical Device, the CE Mark is required in order to sell the system in Europe. — CE mark on the EU flag. Source.

1. CE Mark

What is a CE Mark?

Regardless of where in the world you are, you’ve likely seen the CE mark on many products you own, though it only applies to shipping products into the European Union (EU) and the United Kingdom (UK). This is because the CE mark is required for many products as a way to indicate to EU customs and the consumer that this product meets the safety requirements set by the EU.

What makes CE marks tricky is what also makes them easy – no one gives you a CE mark, you apply it yourself after determining your “product meets all applicable EU requirements”. This is helpful since you don’t need to wait for a regulatory body to review your submission ahead of putting your product on the market (such as with the FDA), but can be difficult for small creators since the onus of understanding the regulations fall to you.

If you want more history and background on the CE mark, check out the official website of the European Union.

What products need a CE mark?

The eagle-eyed among you might have caught my last paragraph said the CE mark is required for “many products”, not all products. (Congratulations, your reward is a promising career in Regulatory Affairs!) That is because not all products do require a CE mark, and this is the first stumbling block for many.

Let’s start by looking at the EU’s website and its list of products for where a CE mark is mandatory.

Well that didn’t take long, first on the list: “toys”.

Each different product category has its own set of regulations that need to be considered. The list of directives/regulations for the various product categories can be found on a different page of the EU’s website. Again, first on the list, Toy Safety – Directive 2009/48/EC. Beware, products can have multiple categories. For example, if you’re selling an electro-mechanical in vitro medical device, you have at least 3+ safety standards you need to be reviewing. You can review this list of standards to make sure you are assessing all relevant standards, though you’ll likely just need the Toy Safety Directive.

So what does this have to do with which products need a CE mark? Patience, we’re almost there.

Open up Toy Safety – Directive 2009/48/EC (this is where we will be spending most of our time). Again, right at the top:

This means that in the eyes of the EU, your game is a “toy” and therefore needs a CE mark if it may be played by children under the age 14. This section is the source of a lot of misinformation you’ll find online. You’ll find people incorrectly stating “well if you just put ages 14+ on your box, then you don’t need a CE mark.” That is NOT true. (As a rule of thumb, cute loopholes never work with regulatory bodies.)

This clause is stating that if a product would appeal to a child under the age of 14, it is a toy. So if you, or more importantly an outside observer, could reasonably foresee a child under 14 playing your game, then it’s a toy and needs a CE mark.

Your game is not a toy and doesn’t need a CE mark if you can justify that it is purely meant for adults due to it’s content, complexity, or other nature. But again, a lot of gray area here. Let’s look at some examples:

Gloomhaven: CE marked. That’s right. One of the most complex games out there has defined itself as a toy and has a CE mark. It appears earlier versions of the game did not have a CE mark. We can only speculate but maybe due to the miniatures, increased popularity, or just getting tired of talking to customs they eventually decided to get a CE mark. So before you start thinking your game is too complex to be a toy, just remember that Gloomhaven is.

Earthborne Rangers: No CE mark. Another very complex campaign game, but this time no CE mark. Possibly because the box has no miniatures, just cards and tokens, they found it easier to justify as a game for adults? Hard to say, but they must have a justification that they feel is sufficient.

Magic the Gathering: CE marked. Same with Pokémon and Yu-Gi-Oh.

Right: Cards Against Humanity original game, Left: Cards Against Humanity Absurd Box. Source, CAH website

Cards Against Humanity: Both with and without CE mark. Now here’s a real head scratcher for you. The original game does not have a CE mark, but one of the expansions does – even though it also explicitly states “ages 17+”.

Suffice to say, there is ambiguity around which products do and do not need a CE mark, though many adult targeted games carry a CE mark.

So does my game need a CE mark or not?

I would suggest that unless you feel very confident reviewing the regulations and penning a sufficient justification, that you should pursue a CE mark. The risk of not getting one is that customs will hold your shipment until you can provide an adequate explanation for why your product does not need a CE mark. Even if they eventually agree, the process of sharing your paperwork and customs reviewing and approving can result in weeks or more likely months of delays getting your game to your customers.

I’ve decided my game is truly only for ages 14+, does that mean I can just put on a CE mark without any other work?

Darth Vader No GIFs - Find & Share on GIPHY

Little side track here since this is another common misconception I’ve seen. Determining that your game is not a “toy” and therefore no EU regulations apply to it does NOT mean that you can put a CE mark on your game. Instead it means that you do not need a CE mark. This is a very very different situation. If you improperly put a CE mark on a product without having the proper documentation you can face very real consequences such as fines or even jail time.

My game needs a CE mark, how do I get it?

Our good friend Toy Safety – Directive 2009/48/EC tells us exactly what is needed in order to put a CE mark on your game. It comes down to doing testing, putting together some basic documentation about your game, and putting the right information on the box.

But don’t take my word for it, let’s look at the directive!

Reviewing Toy Safety – Directive 2009/48/EC

Reviewing standards may seem like the worst thing in the world to you, but they are the source of all answers. If you’ve read your 10th blog post on CE marks and thought “I wish I could just talk to the EU directly”, well reading a standard is about as close as you can get. So let’s crack it open and find the actual answers.

So you have Toy Safety – Directive 2009/48/EC open (you better, I linked to it enough times now). Don’t be discouraged by it being 49 pages long (having reviewed much much worse, I was actually really excited when I saw it was only 49 pages). A lot of a standard consists of definitions, appendices with tables that don’t matter, and sections that do not apply. This one is probably closer to 20 relevant pages with large spacing and margins.

I’ll pull out the sections that define what you as the publisher have to do upfront to apply the CE mark, but if you want to be more informed I’d recommend at least skimming over the rest of the document.

Article 4.(1)

“When placing their toys on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements set out in Article 10 and Annex II.”

While seemingly unobtrusive on it’s own, this is actually a big one and where the requirement for safety testing comes in. This article references Article 10 and Annex II. Jump to Article 10 and you’ll see it’s also basically a redirect to Annex II. So let’s go there now since that leads us to safety testing.

Annex II Particular Safety Requirements

This Annex contains specific safety requirements that toys must meet. It is broken into multiple parts, organized by types of requirements:

I. Physical and Mechanical Properties

II. Flammability

III. Chemical Properties

IV. Electrical Properties

V. Hygiene

VI. Radioactivity

At first glance there appears to be a lot of detail, but if you look at a requirement like 1.4.(b) “Toys and their parts must not present a risk of asphyxiation by closing off the flow of air as a result of airway obstruction external to the mouth and nose.” you might think, ok but that doesn’t seem very testable, how do I certify that for my game? (If you thought that, congrats again on your future in RA or Systems Engineering!) That’s because Annex II and the Toy Safety – Directive 2009/48/EC represent the essential safety requirements for games to meet, but not how to test those requirements.

Defining test setups and acceptance criteria is really detailed work, and in order to keep the regulations more orderly the testing standards have their own documentation. For toys testing is defined by the EN 71 series of standards, which contains details like this:

We don’t have to go too deep into the weeds here, because testing to EN 71 is what a safety testing lab will do for you. What you need to be aware of though is there is a series of standards that comprise EN 71 and not all apply to your game.

Generally speaking three of the standards are likely to apply:

EN 71-1: Mechanical and Physical Properties: This standard sets requirements for the mechanical and physical properties of toys, such as size, shape, strength, and durability.
EN 71-2: Flammability: This standard establishes criteria for the flammability of toys, ensuring that they do not present a fire hazard. This one may not apply based on what materials you use.
EN 71-3: Migration of Certain Elements: This standard limits the migration of certain potentially harmful elements, such as heavy metals (lead, cadmium, mercury) and certain organic compounds, from toys into children’s bodies.

Again, no need to be an expert on these, good test houses will know which standards can be ignored. But you having a basic knowledge here will be helpful to make sure they aren’t testing beyond the scope of your game such as including testing for EN 71-7: Finger Paints.

Okay, this was the big one. We can count Article 4.(1) and Annex II as covered. The takeaway here:

📌EU/UK Requirement 1: Your game needs EN 71 testing.

If you’re working with a big manufacturer they likely have the ability to do this testing or know of a test lab to send it to. Testing will likely range from $300-800 depending on the tests that apply to your game. The test lab will then deliver you a test certificate that you can store in your game’s technical file (which we’ll cover later).

Now let’s move on to the next Article

Article 4.(2)

“Manufacturers shall draw up the required technical documentation in accordance with Article 21 and carry out or have carried out the applicable conformity assessment procedure in accordance with Article 19.

Where compliance of a toy with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EC declaration of conformity, as referred to in Article 15, and affix the CE marking, as set out in Article 17(1).”

Another article with crucial redirects. This is saying you have to have all the documentation that is required per Article 21, and you can to assess if your game meets all applicable standards per Article 19. The second paragraph then says if you’ve done that, you can apply a CE mark per the requirements of Article 17(1).

We’ll get to Article 21 in a moment, but let’s dive into Article 19 since it is a confusing but important article.

Article 19 is long so I won’t copy it here, but it is essentially saying you have two ways to get the CE mark: 1) via self assessment if you were able to test your game per EN 71 standards, or 2) via submitting to a notified body for review if your game is outside the bounds of EN 71. Option 2 means it contains materials or has attributes that are not covered by or are beyond the limits of the EN 71 standards.

Almost all standard board games will follow option 1, but let’s go through two examples to be clear.

Example 1. You have a standard board game and you determine that EN 71-1 and EN 71-3 are the two testing standards that apply. You also determined that together they cover all relevant safety requirements for your game. You pass all the tests and get the test documentation.
➡️ Follow option 1, applying the CE mark via self assessment.

Example 2. You have a board game with a novel element like a super fast disc launcher. Your launcher shoots objects at speeds faster than those allowed for “projectile toys” per the standards, and therefore is not covered by the EN 71 testing.
➡️ Follow option 2, submit your product to a notified body for them to assess your products design and then approve it only if they see fit.

Option 2 is incredibly rare and really only in edge case scenarios. If you find yourself here, reconsider you decisions because this process looks really sticky and I’m not going to get into it. If you have a standard game, it’s safe to assume that you can do self assessment, but confirm for yourself by talking to your manufacturer or safety test house on the applicability of the safety standards.

Article 17(1) then basically says that must have the CE mark legible.

This covers Article 4.(2), Article 19, and Article 17(1). The takeaway:

📌EU/UK Requirement 2: You can follow self assessment to put the CE mark on your product.

Article 4.(3-4) talks about document retention and process continuity to ensure you’re maintaining conformity. No upfront requirements there so we move on.

Article 4.(5)

“Manufacturers shall ensure that their toys bear a type, batch, serial or model number or other element allowing their identification, or, where the size or nature of the toy does not allow it, that the required information is provided on the packaging or in a document accompanying the toy.”

Yay an easy straightforward one! This is saying you have to have some way to identify this batch of product so that if a recall happens you can identify which products have been affected. Any way to identify the product should work, just as putting a lot number, print edition number, etc. If you’re product is too small this article appears to allow for placing that information in the rulebook.

📌EU/UK Requirement 3: You need to include a batch/lot/model/version number somewhere visible on the packaging (or in the rulebook if it’s too small).

Article 4.(6)

“Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the toy or, where that is not possible, on its packaging or in a document accompanying the toy. The address shall indicate a single point at which the manufacturer can be contacted.”

This article has two requirements for what needs to be on the label – the manufacturer name and contact address.

Remember to the Toy Safety Directive you as the publisher are the manufacturer not whoever printed your game. This means you need to put your company name on your label.

For the contact address, this will be the address of your “responsible person” as defined by General Product Safety Regulation (EU) 2023/988. We’ll cover that in a separate section after finishing the Toy Safety Directive, but know that your label needs the address of your Authorized Representative or other “responsible person”.

📌EU/UK Requirement 4: Your label needs your company name.

📌EU/UK Requirement 5: Your label needs the address of your Authorized Representative or other “responsible person”.

Article 4.(7)

“Manufacturers shall ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers, as determined by the Member State concerned.”

Instructions here do not mean a rulebook. This means any sort of warning or instructions for how to use the toy to prevent injury. It’s possible that you’re game will not have any such warning requiring translation.

We’ll get to what warnings you need in a moment with Article 5, but if you do need a warning translated the EU website has a list of guidance documents for Toy Safety, including a very helpful document that lists all the EU translations for the toy specific warnings.

The good news here is not all translations need to be on the outside of the game . You can put the full list of translated warnings in the rulebook if you have space, or on a separate insert designed to be recycled after players open the packaging.

📌EU/UK Requirement 6: If your game has written warnings, you must have the warnings written in each EU language per country you plan to ship to.

Article 11 Warnings

“1. Where appropriate for safe use, warnings made for the purposes of Article 10(2) shall specify appropriate user limitations in accordance with Part A of Annex V…

2. The manufacturer shall mark the warnings in a clearly visible, easily legible and understandable and accurate manner on the toy…

Warnings which determine the decision to purchase the toy, such as those specifying the minimum and maximum ages for users and the other applicable warnings set out in Annex V, shall appear on the consumer packaging ….”

Here we get redirected to Annex V for what the warning requirements are, and then instructions for how to place the warnings.

Annex V Warnings

“Part A General Warnings, The user limitations referred to in Article 11(1) shall include at least the minimum or maximum age of the user and, where appropriate, the abilities of the user, the maximum or minimum weight of the user and the need to ensure that the toy is used only under adult supervision.”

This is not your recommended age range for your game, this is if you have a toy that has specific age requirements due to safety (such as kid’s bike with specific ages for safety). This likely doesn’t apply to you, other than for kids under 3, which we’re about to get to.

Part B of Annex V is specific warnings that must be applied based on the category of your game. There are 10 sections here, but most do not apply since they are for categories like chemical toys, aquatic toys, toys in food, etc. Read through it for yourself, but for a standard board game the only one likely to apply is:

“1. Toys not intended for use by children under 36 months
Toys which might be dangerous for children under 36 months of age shall bear a warning such as ‘Not suitable for children under 36 months’ or ‘Not suitable for children under three years’ or a warning in the form of the following graphic:”

Some interpretation is needed here for the line “which might be dangerous for children”. There’s not clear requirements I can find that list specifically what would make a game “dangerous”. Using some common sense though, if your game contains small pieces, pokey bits, or other things you wouldn’t want to hand to a toddler, then this likely applies.

My game, which only consists of cards and a plastic wallet, is on the edge here. However, this icon is easy to apply, and rather than having customs reject my game (or worse having an incident with my game without this warning), I’ve determined its best for me to apply this label even if it is a little conservative.

The section also allows you to decide between putting the written warning or the icon. Remember from 4.(7) that if you have written warning you have to translate them per country requirements. I want to avoid that so I’m going to just use the icon.

The next part of the section needs to be broken down a little more since it at first glance appears to undermine my translation strategy:

“These warnings shall be accompanied by a brief indication, which may appear in the instructions for use, of the specific hazard calling for this precaution.”

This would mean including a reason for the age restriction, such as “contains small parts, choking hazard.” So translations are back on the table? Not yet. Let’s get to the last paragraph of the section:

“This point shall not apply to toys which, on account of their function, dimensions, characteristics or properties, or on other cogent grounds, are manifestly unsuitable for children under 36 months.”

This is saying you do not need any extra text other than the icon if your game is “manifestly unsuitable for children under 36 months.”

While it was a gray area to determine if my game could be “dangerous” per the directive, I think it’s very clear that this strategy card game is “manifestly unsuitable” for kids under 3, so I’m choosing to not include any additional language that would require translations.

None of the other warnings apply to my game, so I’ll only be putting the icon for no kids under 3. This is probably true for most games, but again you should assess for yourself.

📌EU/UK Requirement 7: Include any applicable warnings in Annex V – likely just the “Not suitable for children under 36 months” icon.

Article 21 Technical documentation

“1. The technical documentation referred to in Article 4(2) shall contain all relevant data or details of the means used by the manufacturer to ensure that toys comply with the requirements set out in Article 10 and Annex II. It shall, in particular, contain the documents listed in Annex IV.”

Ok, Annex IV lets us know what documents we need to keep on file to support our CE mark. There are 8 pieces of technical documentation required to keep on hand if the EU comes calling, items (a)-(h).

The Toy Safety describes these documents at a high level, a really high level, a level so high you can’t determine any detail at all. But here’s another tip when working with standards – search out any relevant guidance documents. Guidance documents are put out by the standards body as a way to help interpret confusing language in the standards, or zoom in more on those high level sections. Think of it like an errata or FAQ for a game!

There are a whole list of Toy Safety guidance docs, but the relevant one to us here is the guidance document specific to technical documentation.

Now let’s go through Annex IV (a)-(h) and lean on the guidance doc to help us know what we need to include.

(a) a detailed description of the design and manufacture, including a list of components and materials used in the toy as well as the safety data sheets on chemicals used, to be obtained from the chemical suppliers;

You should be able to easily get this from your manufacturer. There are examples in the guidance document, but it’s basically a description of the product and a list of everything it contains. Pretty straight forward.

(b) the safety assessment(s) carried out in accordance with Article 18;

Article 18 doesn’t say much more, so we need to rely on the guidance document for this one. I actually have put together many detailed safety assessments per ISO 14971 (risk management for medical devices), so this is a section I’m very confident interpreting and talking to.

In general, safety assessments are there to show that you’ve thought about all the potential hazards that could arise from your product, and have taken steps to mitigate the risks of the hazards as far as possible. Regulators want to make sure you’re considering safety in your design and not missing any potential issues that may lead to a recall.

The guidance doc lays out 3 steps for doing your safety assessment: “1) identify the toy [or component], 2) describe it’s use, 3) identify hazards.” I added [or component] because I think that’s an easier way to go through the safety assessment for a board game that has multiple parts that may have different hazards. Once you have the hazard identified then list what mitigations you have in place and if there is any residual risk.

Let’s use Battleship for an example:

Amazon.com: Hasbro Gaming Battleship Classic Board Game, Strategy Game for Kids Ages 7 and Up, Fun Kids Game for 2 Players, Multicolor : Everything Else

Two potential risks that jump to my head are sharp edges causing cuts, and small pieces causing choking. The Toy Safety Directive isn’t overly descriptive in what’s required in the safety assessment, so let’s keep it simple and simply include the component, the hazardous situation, the resulting harm, the mitigation(s) in place, and the residual risk. This is usually best done in a table as such:

Here’s a hint for your mitigations, any hazard that you identify should be tested or assessed by the Toy Safety Directive, either as a labeling requirement or a part of the safety testing. That is the point of the standard after all, to make sure you’re producing a safe game. So for each risk you identify, on top of any other safety specific design choices you made, make sure one of the mitigations is something from this standard.

You’re taking credit for the work done here, but more importantly you’re showing that you don’t have any hazards not covered by the standard.

If you discover a hazard in your game that is not covered by safety testing this means you are outside the bounds of this standard and potentially must submit to a notified body for your CE mark rather than doing the self assessment, like we talked about in Article 4.(2) and 17 above. But just like we discussed there, this is likely a very rare situation. If you do have a risk that isn’t mitigated by the labeling of safety testing, reach out to your safety test house to see if in fact they do test for that. On top of having a more complete risk assessment, this is also good practice to ensure your game is being tested for proper safety.

Make the safety assessment as many lines as you need to in order to capture all the potential risks. You don’t need to go over board and start inventing outlandish situations, but think how you’d defend your product if someone came to you and asked you if you thought it was safe.

(c) a description of the conformity assessment procedure followed;

This is documenting whether you did self-assessment, or submitted to a notified body, and why. Again, you likely followed the self-assessment path, so in your technical documentation include a statement saying you performed first party conformity assessment with the rationale that your product is covered by the standards.

Something like “RAM Games, Quickdraw, [product identifier], utilized first party conformity assessment. This is due to the harmonized standards EN 71-1, EN 71-2 covering all relevant safety requirements of the product. Safety testing was completed by XXXXX and passed all relevant tests on DD-MM-YYYY. The risk assessment shows no unmitigated residual risks.”

(d) a copy of the EC declaration of conformity;

Whereas (c) was sort of the story of what you did, this is the official declaration. They didn’t link to it this time, but the requirements for what makes up your EC DoC is actually in Annex III.

“1. No … (unique identification of the toy(s))
2. Name and address of the manufacturer or his authorised representative:
3. This declaration of conformity is issued under the sole responsibility of the manufacturer:
4. Object of the declaration (identification of toy allowing traceability). It shall include a colour image of sufficient clarity to enable the identification of the toy.
5. The object of the declaration described in point 4 is in conformity with the relevant Community harmonisation legislation:
6. References to the relevant harmonised standards used, or references to the specifications in relation to which conformity is declared:
7. Where applicable: the notified body … (name, number) … performed … (description of intervention) … and issued the certificate:
8. Additional information: Signed for and on behalf of: (place and date of issue) (name, function)(signature)”

Copy out that info for your game and you’ve got it.

(e) the addresses of the places of manufacture and storage;

List the address of your manufacturer and if there are any locations where the game was stored before being sent to the EU, include those as well.

(f) copies of documents that the manufacturer has submitted to a notified body, if involved;

Not applicable unless you submitted to a notified body (which you probably didn’t.

(g) test reports and description of the means whereby the manufacturer ensured conformity of production with the harmonised standards, if the manufacturer followed the internal production control procedure referred to in Article 19(2); and

Include all safety test reports performed. These should not show any failures or non-compliances. If they do, you better have a very good explanation for why if a regulator comes knocking.

(h) a copy of the EC-type examination certificate, a description of the means whereby the manufacturer ensured conformity of the production with the product type as described in the EC-type examination certificate, and copies of the documents that the manufacturer submitted to the notified body, if the manufacturer submitted the toy to EC-type examination and followed the conformity to type procedure referred to in Article 19(3).”

Again, not applicable for self assessment.

So all in all that gives us the following technical documentation requirements:

📌EU/UK Requirement 8: A saved file of technical documentation for your game, including:

📌EU/UK Requirement 8.1: A list of all components and materials

📌EU/UK Requirement 8.2: Safety assessment

📌EU/UK Requirement 8.3: Description of the conformity assessment procedure followed

📌EU/UK Requirement 8.4: EC declaration of conformity

📌EU/UK Requirement 8.5: the addresses of the places of manufacture and storage

📌EU/UK Requirement 8.6: Safety test reports.

And with that we’ve pulled out every requirement from the Toy Safety – Directive 2009/48/EC which will allow us to affix a CE mark to our product. A huge item checked off our list but it’s not the only thing needed to ship your game into the EU/UK.

What about the UK?

All of this talk so far has been about the EU, which since Brexit, does not include the UK. Are there different rules for the UK? Luckily no. The UK does have it’s own UKCA mark, very similar to the CE mark, but at this time the UK still accepts the CE mark to sell products into the region.

No new requirements here!

Final list of requirements to get a CE Mark: