Lately there’s been a lot of discussion within the publishing industry about the General Product Safety Regulation (2023/988), which came into force in the EU on 13th December.

The GPSR is intended to bring in more consumer protection and better safety measures for products across industries (that are not otherwise regulated). For the publishing industry, this means books. But there is a lack of clear, specific guidance, which has left some people in the dark about their responsibilities.

I’ve spent the past 9 years in medical device regulation and I’m a published author, which means this is a strange niche for me. Although this post does not constitute legal advice, I thought I’d try to shine some light on this regulation and the alien language that I’ve spent the best part of a decade getting familiar with.

Definitions

All of the above roles are economic operators, which forms a supply chain from the manufacturer to the end user or customer (or in the publishing world, the reader).

For traditional publishing, the manufacturer would be the publisher (unless a book is self-published, making the author the manufacturer). Publishers without an established presence in the EU (or NI*) need to appoint an authorised representative, who effectively takes on the responsibilities of the manufacturer in the EU. Being established within the EU means having a registered office in an EU member state.

*for the purposes of this regulation, NI is considered to be part of the EU, however GB (England, Scotland, & Wales) should have unfettered access to the NI market. More guidance here, and the Windsor Framework details how to show that goods are not at risk of moving into the EU via NI.

The importer must be based within the EU, but bookshops based in GB will generally be considered distributors when selling into the EU. A fulfilment service provider might be an entity like Amazon.

Responsibilities

The manufacturer (and their EU rep, if applicable) must draw up certain technical documentation which proves the compliance of the products they place on the market. There is usually an ongoing fee for appointing an EU authorised representative, due to the level of work they have to undertake, but not for an importer, as they are usually part of the supply chain anyway (and often physically handle the goods themselves, whereas the EU authorised representative usually does not). Distributors, or bookshops, are not expected to appoint an EU authorised representative or have an established EU presence, only manufacturers.

From my experience in medical device regulation, it can be simpler for the manufacturer to appoint a single importer who is based in the EU, such as a bookshop they regularly sell to, but there can be multiple importers for the same products. A written agreement should be in place for all economic operators to ensure clarity on where each obligation lies.

Verifying the existence of an importer is just one part of the distributor’s responsibilities. Distributors must ensure they only make available on the market* products which are compliant with Articles 9(5), (6) and (7) and Article 11(3) and (4), as applicable. Article 12 of the GPSR lays out these responsibilities in more detail.

*there has been many a discussion over the years about what ‘making available on the market’ means, but it effectively means that you are selling a product into the EU market. (Note that this also applies to products provided free of charge, so proof copies would not be exempt from the regulation.)

Transitional arrangements

There are often transitional arrangements (or ‘sell-off’ periods) when new regulations enter into force. This means that the regulation does not apply to stock already placed on the market. However, for books, this does leave something of a grey area.

The GPSR states that it applies to products placed or made available on the market whether new, used, repaired or reconditioned. Antiques are exempt from the GPSR, but there is no specific guidance for second-hand books. In my view, it would be unreasonable for the regulation to apply retrospectively to such a degree, especially since books do not have an expiry date, and there may be cases where the publisher has gone out of business and/or the author is dead. In such cases, it is unclear who would take responsibility, and some clarity is needed.

It is also unclear what the labelling requirements are for books. There are specific mentions of labelling being required regarding age suitability for children, any warnings and instructions for its safe use and disposal, and any other indication or information regarding the product, as well as information supplied by the manufacturer, such as their name, address, and contact details, and product identification, such as a batch number. The importer’s details must also be present on the labelling. Unlike medical devices, there do not appear to be any harmonised symbols for GPSR labelling, but some general advice can be found here.

Next steps

For distributors, the first step should be to check what documentation the manufacturer holds to prove compliance with the GPSR. This should include technical documentation which shows that all of the aspects of Article 6 have been considered, in order to be compliant with Article 5. This Bookseller article mentions that there is currently no ‘ONIX-based route for getting full GPSR contact information into the hands of retailers’ according to David Aldridge, chief technology officer at Consonance.app, so the way in which this information should be held by publishers is currently unclear. I would be interested in what the big four publishers have done to ensure compliance, as they have more capability (and budget) to bring in regulatory resource than independent publishers.

However, it would benefit all economic operators to seek regulatory advice to ensure they are in compliance with the regulation. This can be in the form of an external consultant or hiring someone in-house.

This post is only a brief outline on the GPSR and how it affects the publishing world. For specific advice, I’m available on a consultancy basis – click here to get in touch, or email me at vikkipatiswrites@gmail.com