A Legal Double-Whammy: Language and Surveillance Obligations
You might not realise it, but if you’re selling in the EU, the legal compliance bar just got a lot higher, especially in the face of surged use of the Safety Gate Rapid Alert System (formerly RAPEX).
Under General Product Safety Regulation (EU) 2023/988, key clauses enforce two critical requirements:
- Multilingual consumer materials (Article 9(7)):“Safety information… shall be provided in a language that can be easily understood by consumers, as determined by the Member State…”Translation: You must offer instructions, warnings, manuals, and labels in the official language(s) of every market you sell into. No exceptions.
- Consumer complaint handling (Article 20) and post-market monitoring (Article 24):Economic operators must collect and manage consumer safety complaints in a manner accessible, easy to use, and in local language, with systems that scale with product volume and market reach.
Recital 45 of the Tobacco Products Directive reinforces this principle:
“A system for the collection of information about all suspected adverse effects… should be established. The system should be adequate and robust to meet the needs of the number of products and consumers on the market.”
These aren’t the only regulations with such requirements:
- Cosmetics Regulation (EC) 1223/2009 – Article 23: Requires responsible persons to report Serious Undesirable Effects (SUEs) to authorities without delay.
- Toy Safety Directive (2009/48/EC – Article 20): Manufacturers must report risks and incidents, including RAPEX notifications.
- PPE Regulation (EU) 2016/425 – Articles 8 & 14: Requires monitoring and complaint handling proportional to the product’s risks.
- Medical Device Regulation (EU) 2017/745 – Chapter VII: Mandates a full vigilance system for tracking incidents and issuing field safety notices.
In short, no matter what type of consumer product you sell: toys, cosmetics, PPE, vapes, or medical devices, EU law expects you to have a post-market system that’s scalable, responsive, and multilingual.
Enforcement Is Mounting: RAPEX Alerts Have Hit an All‑Time High
The European Commission’s 2024 Safety Gate report delivered a wake-up call:
- 4,137 alerts validated in 2024 — the highest tally since the system began in 2003.
- 4,279 follow-up actions taken by national authorities.
- Most flagged: cosmetics (36%), then toys and electrical appliances.
- Year-on-year: 20% increase in alerts; 1,256 product recalls.
If your product hits this system and you’re not equipped to respond quickly and at scale, regulators will show no mercy.
Why This Matters for Your Business
If you’re receiving millions of monthly orders, you could face tens of thousands of safety reports, in multiple languages. A spreadsheet or Gmail inbox simply won’t cut it.
Without a scalable, multilingual, complaint-handling system, you risk:
- Product withdrawals or bans
- Substantial fines
- Criminal charges if harm occurs
VIGIL: Built for Cross-Sector Compliance and Safety Gate Preparedness
We created VIGIL to solve this exact problem:
- Multilingual intake in 28 languages
- QR-code or link-based consumer submissions
- Automated routing, categorisation, and tracking
- Scales from dozens to tens of thousands of reports/month
- Built-in audit trail to satisfy regulators
Whether you’re shipping thousands or millions in cosmetics, toys, PPE, vapes, electronics, or medical, VIGIL ensures you’re compliant before your product shows up on the Safety Gate radar.
Summary Table: Why Every Serious EU Seller Needs a Scalable Safety System
| Issue | Legal Basis | Risk if Lacking System | Vigil Advantage |
|---|---|---|---|
| Language Compliance | GPSR Art 9(7) | Non-compliant manuals/labels | Auto-translated user workflows |
| Complaint Intake & Safety Monitoring | GPSR Art 20 & 24, TPD Recital 45, Cosmetics Reg Art 23, Toy Dir Art 20, PPE Reg Art 8/14, MDR Ch VII | Cannot meet volume requirements/scale | Multilingual intake, route, classify |
| Exposure to RAPEX / Safety Gate | Cross-sector EU enforcement mechanism | Alerts + penalties + brand damage | Full audit trail for investigations |
Final Word — Heads Up
We’re offering you a legal service disguised as advice, and saving you from headaches and enforcement risks down the line. This is not optional housekeeping; it’s a core obligation under EU law.
If you’re growing internationally, selling across the EU in volume, build your safety infrastructure before regulators or consumers force your hand.
👉 Learn how VIGIL lines up with GPSR, TPD, Cosmetics, Toys, PPE, and Medical Device Regulations — and keeps you out of the Safety Gate spotlight.
