Limonchito working document, published as-is. Prices and lead times are estimates from September 2026 and change often.
Lemon – EU/NL compliance plan (production batch of 300–500 units)
Status as of 2026-09-17. Scope: the Lemon (nRF9151 LTE-M, 250 mAh 602025 LiPo, BQ51013B Qi receiver; rev B adds an LED and an accelerometer) and the rev B leaf cradle (Qi transmitter, USB-C input). The developer is an NL person or eenmanszaak acting as manufacturer. Because the cell comes from AliExpress, the developer is also the importer of the battery. "UNVERIFIED" means I could not confirm it from a primary source this session. Lab prices are not published by any EU lab, so every cost below is an estimate to replace with real quotes.
0. URGENT – Battery Regulation Art. 11 (removability), applies 18 Feb 2027
Verdict
The current sealed, overmolded Lemon does not comply for any unit placed on the market on or after 18 Feb 2027. None of the exemptions fit.
What Art. 11(1) requires (Reg. (EU) 2023/1542, Art. 11; the date is in Art. 96(2)(a)): - The battery must be "readily removable and replaceable by the end-user at any time during the lifetime of the product". This covers the whole battery, not individual cells. - Readily removable means removable "with the use of commercially available tools, without requiring the use of specialised tools, unless provided free of charge with the product, proprietary tools, thermal energy, or solvents". - Desoldering counts as thermal energy. Cutting open a cast PU skin damages the product, so it fails too. - Replaceable (Art. 11(6)) means another compatible battery can go in without affecting function, performance or safety. - Spare batteries must be available for 5 years after the last unit is placed on the market, at a reasonable price (Art. 11(7)). - Software must not block a replacement battery (Art. 11(8)). - Removal and replacement instructions must ship with the product and stay permanently online (Art. 11(1)).
Commission guidelines are published. The first was Notice C/2025/214 (Feb 2025). An updated version is C(2026) 5032, 14 Jul 2026. Key points: - "Commercially available tools" covers EN 45554 basic tools / no tools and commercially available tools. Proprietary tools are not allowed. - The "end user" is an adult with no repair experience. - Removal must avoid "damage to the battery and to the device". - The requirement "is not applicable to products placed on the market … before … 18 February 2027" (§5.2).
Exemptions after the 14 Jul 2026 delegated act. The act is C(2026) 5031, announced in a Commission news item. Whether it has been published in the OJ yet is UNVERIFIED.
| Exemption | Result | Applies to Lemon? |
|---|---|---|
| 11(2)(a) Appliances, incl. wearables, used primarily in splash/jet/immersion environments and washable/rinseable | Only an independent professional needs to be able to replace the battery | No. The Lemon is not primarily used wet. Guidelines §3.2.1: an IP rating alone is not enough, and you must show "no way to redesign". |
| 11(2)(b) Professional medical imaging/radiotherapy, IVD | Professional | No |
| 11(2)(c) Wearables that are too small, or rely on a compact sealed enclosure | Professional | No. A wearable is "worn on the body". The Lemon is hand-held. |
| 11(2)(d) Electric toys with rechargeable batteries, until 31 Jul 2030 | Professional | Only if the Lemon is a toy (see §4). You don't want that. |
| 11(2)(e–h) Food probes, ATEX, on-body drug delivery, roof telematics | Professional | No |
| 11(3) Continuity of power for safety, or data integrity where collecting data is the main function | None needed | No. Guidelines §4 give life-sustaining devices, smoke alarms, loggers and POS as examples. |
Even the "professional" exemptions still require removal with commercially available tools and without destroying the product (Guidelines §3.2). A potted battery fails every route.
Two legal paths
- Redesign now. This is recommended, and it is the minimum change: - Battery on a connector. Use a keyed 2-pin JST-SH/PicoBlade-class connector instead of soldered leads. - No glue or tape on the cell. Use a foam pad and a clip or rib retention. - Openable closure. Replace the permanently glued clamshell with a rigid core that opens with a twist-lock or bayonet bottom cap (no tools) or 2× Phillips/Torx M1.6 screws. - PU skin becomes a removable sleeve, or is cast only on the top half so the Qi cap stays accessible. - Keep the dome windows sealed with the existing PET film. - Publish a replacement-cell spec: 602025, 3.7 V, 250 mAh, integrated PCM, connector pinout, IEC 62133-2 and UN38.3. Stock spares for 5 years. - Move the SIM and pogo test pads under the same cap. This also fixes labelling (§5) and service. - Firmware must not reject a new cell (Art. 11(8)).
- Get every unit placed on the market before 18 Feb 2027. Placing on the market happens per individual unit (Blue Guide 2022, §2.3). Each unit must be finished and supplied to a distributor or customer by 17 Feb 2027. - Unsold stock in your own warehouse after that date cannot be sold. - Warranty replacements shipped later count as new placements. - This is 5 months from today, with testing (8–14 weeks) still to do. High risk; treat it only as a fallback. Whether webshop stock counts as "placed" when offered is UNVERIFIED.
Other battery duties (portable battery, you are importer and producer)
| Duty | Applies? | Source |
|---|---|---|
| Substances (Hg, Cd, Pb limits, Annex I) | Yes. Get a supplier declaration. | Art. 6 |
| Battery conformity module A, EU DoC for the battery, CE on the battery (or its packaging if not possible), since 18 Aug 2024 | Yes. As importer you must hold the battery maker's DoC and technical documentation. AliExpress sellers rarely have these. Buy from a supplier who does. | Arts. 17–20, 18, 38, 42 |
| Separate-collection symbol (since 18 Aug 2025) | 3 % of the 25×20 mm face = 3.9 mm per side, which is under the 4.7 mm floor. No symbol on the cell. Print a symbol of at least 10×10 mm on the packaging. | Art. 13(4) |
| General label and capacity label | From 18 Aug 2026 or 18 months after the implementing act, whichever is later. Whether the implementing act has been adopted is UNVERIFIED. | Art. 13(1),(2),(10) |
| QR code (DoC, label info, waste info) | Yes, from 18 Feb 2027, on the battery. If it doesn't fit: packaging plus accompanying documents. | Art. 13(6),(7) |
| Producer registration and EPR in NL | Yes. Portable batteries go through Stichting OPEN, not EPAC (EPAC covers e-bike batteries only). 2026 fee for a Li-ion battery ≤50 g: €0.038 per battery. | Art. 55; ILT; OPEN battery tariffs 2026 |
| Registration in every other Member State you sell into | Yes (Art. 55(2)). Distance sellers may need an authorised representative. | Art. 55–57 |
| Due diligence | No. It is exempt below €40 M turnover (Art. 47), and the start was postponed to 18 Aug 2027 by Reg. (EU) 2025/1561. | Arts. 47–52 |
| Carbon footprint | No. It applies only to EV, LMT and industrial batteries over 2 kWh. | Art. 7 |
| Battery passport | No. It applies only to LMT, EV and industrial batteries over 2 kWh. | Art. 77 |
1. Radio Equipment Directive 2014/53/EU
Conformity route. Module A (self-declaration) is allowed only if harmonised standards covering Art. 3(2) and 3(3) are applied in full. Otherwise a Notified Body (NB) must issue an Annex III type-examination (RED Art. 17). The official list of standards is the Commission RED standards page, including Decision (EU) 2025/893.
| Requirement | Lemon | Cradle | Current version and caveat |
|---|---|---|---|
| 3(2) spectrum – LTE | EN 301 908-1 V15.2.1 + EN 301 908-13 V13.3.1 | – | Caveat: V13.3.1 "does not address receiver TRS nor TRP for radio equipment narrower than 56 mm or wider than 72 mm". The Lemon is 43 mm wide. V13.2.1 stops giving presumption of conformity on 15 Nov 2026. Whether TRP/TRS apply to a non-phone, and so whether an NB is needed for 3(2), is UNVERIFIED. Ask the NB. |
| 3(2) spectrum – WPT (Qi 110–205 kHz) | EN 303 417 (receiver side, tested as a system) | EN 303 417 V1.1.1 (latest ETSI version, ETSI) | Qi carries in-band communication, so the cradle is radio equipment. |
| 3(1)(b) EMC | EN 301 489-1 V2.2.3 + -52 V1.3.1 (+ -3 for WPT) | EN 301 489-1 + -3 V2.3.2 | -52 and -3 give no presumption if their clause 6 is applied (the OJ notice). Use the performance criteria, not the tolerances. |
| 3(1)(a) safety | EN IEC 62368-1:2020+A11:2020 (Annex M batteries → IEC 62133-2) | same | The 2024 edition is not harmonised and unlikely to be (SIQ, Dec 2025). |
| 3(1)(a) RF exposure | EN 50566:2017+A1:2023+A2:2025 (hand-held and body-mounted; cited 07 Sep 2026, A1-only presumption ends 07 Mar 2028). The measurement method is EN IEC 62209-1528. | EN 62479 / EN 50663 (low power) | The Lemon transmits 23 dBm (200 mW) peak with its antenna at 0 mm from the palm. Test limb SAR (4 W/kg) and trunk SAR at 0 mm (2 W/kg): a "hug" gadget will be held to the chest (Rec. 1999/519/EC). EN 50663 time-averaged low-power exclusion (≤20 mW) might avoid SAR testing: UNVERIFIED, lab decision. |
| 3(3)(d) network protection | EN 18031-1:2024 | n/a (no internet) | Notice: no presumption if "the user is allowed not to set and use any password" (6.2.5.1/6.2.5.2) (Decision (EU) 2025/138). |
| 3(3)(e) personal data | EN 18031-2:2024 (squeeze metadata, IMSI and IP tied to a person). Parental-control caveat applies to toy or childcare equipment. | n/a | Same password notice. If the Lemon became a toy, the parental-control caveat would push you to an NB. |
| 3(3)(f) money | EN 18031-3: not applicable | n/a | – |
Cyber timeline. - The RED delegated act (EU) 2022/30 has applied since 1 Aug 2025. It is repealed with effect from 11 Dec 2027, when the Cyber Resilience Act (EU) 2024/2847 fully applies (CSA Group). - CRA Art. 14 reporting (actively exploited vulnerabilities and severe incidents, 24 h early warning) has applied since 11 Sep 2026 (Commission). - Units still selling after Dec 2027 need full CRA compliance.
Reusing the nRF9151 certification. - Nordic holds a CE RED Annex III module B assessment for the SiP (TEC report; nRF9151 certifications). - CE does not transfer to your product. You are the manufacturer of the end product. You can reference Nordic's conducted EN 301 908-1/-13 results if your supply, reference and RF path follow the hardware integration guide. - Still needed on the Lemon: - radiated spurious emissions with your FPC antenna (EN 301 908-1/-13) - full EMC (EN 301 489-1/-52) - safety (EN IEC 62368-1) - SAR - EN 18031 - the TRP/TRS question - Rev B changes (LED, accelerometer) must be in the tested sample. Test rev B only.
Also: - RED Art. 10(8)–(10): instructions, safety info and a (simplified) DoC in Dutch plus the language of each sales country. - The Common Charger Directive (EU) 2022/2380 does not list this product category. The cradle is USB-C anyway. - If you bundle a power adapter, it needs its own CE and must meet the external power supply ecodesign rules.
2. Cell safety and transport
| Item | Requirement | Source |
|---|---|---|
| IEC 62133-2:2017+A1:2021 report for the cell | Needed for EN IEC 62368-1 Annex M. Get it from the cell supplier, with the same cell and PCM part number. | via EN IEC 62368-1 |
| UN38.3 test report and test summary | Mandatory for every lithium cell or battery shipped, including ADR SP188 small batteries. Refuse any cell without one. Its absence is also a customs and market-surveillance flag. | UN Manual of Tests §38.3; Produktkanzlei |
| Shipping finished units | UN3481 (Li-ion contained in equipment). The cell is about 0.93 Wh, so ADR SP188 applies. The lithium battery mark is not needed for ≤4 cells or ≤2 batteries per package in equipment. Bulk cartons to fulfilment need the mark and the SP188 rules. | ADR 2025 |
| PostNL (NL and abroad) | Battery ≤100 Wh / cell ≤20 Wh; "max. 4 cells or 2 batteries in equipment per shipment" (one pair = 2 batteries = OK); no loose cells or spares next to the equipment; not fully discharged; "used lithium batteries may not be sent by post". | PostNL lithium conditions |
Consequences of the PostNL rules: - Spare batteries (required by Art. 11(7)) can't go by standard post. Ship them installed in equipment or by a DG-capable courier (DHL/UPS with a contract). - Customer returns of used Lemons can't go by PostNL post. Arrange a courier return service. UNVERIFIED whether PostNL business contracts allow it.
3. Toy or not?
- Current rules. The Toy Safety Directive 2009/48/EC applies until the new Toy Safety Regulation (EU) 2025/2509 takes over on 1 Aug 2030. Toys compliant with the Directive may be placed on the market until then (Art. 57).
- The test (Art. 2(1)): a toy is designed or intended, "whether or not exclusively, for use in play by children under 14", judged by what "a parent or supervisor can reasonably assume, by virtue of the functions, dimensions and characteristics". A soft, lemon-shaped, squeezable, buzzing object is already close to that line.
- A kid-friendly advert is strong evidence of intended play use. A "14+" or "not a toy" warning does not override the product's characteristics (UNVERIFIED as exact guidance wording, but consistent with Recital 10).
To stay consumer electronics: - Market it as a long-distance communication gadget for couples, friends and grandparents (adults). "Family" can appear only as adult-to-adult use. - No children holding or playing with it in ads or photos. No cartoon faces or play claims. - Label and instructions: "Communication device for adults. Not a toy. Not suitable for children under 14" plus the battery warnings. - Record this classification reasoning in the technical file.
If it is a toy: - Toy CE route: EN 71-1 (mechanical, including small parts/cap and squeeze tests), EN 71-2 (flammability), EN 71-3 (migration of elements from PU and coatings), EN IEC 62115 (electric toys). - The battery compartment must need a tool to open. - Stricter chemical limits (for example PAHs 0.5 mg/kg). - The RED cyber parental-control caveat is likely to require an NB. - Estimated extra cost €4–8k (UNVERIFIED).
4. Other EU/NL obligations
| Topic | What to do | Source |
|---|---|---|
| GPSR | Covers risks outside RED/Battery Regulation (choking on detached nubs, skin sensitisation from PU, misuse by children). Duties: internal risk analysis; technical documentation; type, batch or serial number on the product; name, postal address and e-mail on the product (or packaging if it doesn't fit); instructions and warnings in the local language; product-safety info in the webshop listing (Art. 19); accident reporting via Safety Business Gateway; recall procedure. As an EU manufacturer you are the responsible person yourself. | Reg. (EU) 2023/988, Arts. 9, 19, 20 |
| RoHS | 10 restricted substances, including 4 phthalates, a risk in PU plasticisers. Collect supplier declarations (EN IEC 63000 method). RoHS goes into the single DoC. | Dir. 2011/65/EU |
| REACH | Art. 33: if any SVHC is above 0.1 % w/w of an article, inform buyers (consumers within 45 days) and file a SCIP notification (ECHA SCIP). Annex XVII: PAHs (entry 50) ≤1 mg/kg in PU with prolonged skin contact; organotin catalysts (entry 20); no phenylmercury catalysts (entry 62). Entry 74 diisocyanates (Reg. 2020/1149): anyone hand-casting MDI-based PU professionally must complete certified training (in force since 24 Aug 2023). Get the Polytek SDS and an SVHC statement. | REACH; 2020/1149 |
| WEEE – NL | Register with Stichting OPEN (no registration fee). 2026 recycling fee for small IT, telecom and consumer electronics is about €0.096/kg (under €0.01 per Lemon). Crossed-out bin symbol (EN 50419) on the product or packaging. Other countries need their own registration; Germany (stiftung ear) needs an authorised representative. | Dir. 2012/19/EU; Stichting OPEN; OPEN tariff list |
| Packaging – NL / PPWR | NL: Verpact (formerly Afvalfonds Verpakkingen). Under 50,000 kg a year, no declaration or fee (2026). The PPWR (EU) 2025/40 has applied since 12 Aug 2026: minimise packaging; harmonised material label from 12 Aug 2028; max 50 % empty space in e-commerce packaging from 2030. Germany: LUCID registration from the first package. | Verpact on PPWR |
| EU DoC (one document) | Covers RED, RoHS and Battery Regulation references; standards with versions; NB number if used; signed. A simplified DoC with URL may go in the box (RED Annex VII). | RED Art. 18, Annex VI |
| Technical file (keep 10 years) | Product description and photos; schematics, PCB and BOM; firmware version; risk assessment (RED + GPSR + battery + toy classification); test reports; Nordic module reports; cell IEC 62133-2 / UN38.3 / battery DoC; EN 18031 assessment; RoHS/REACH evidence; labels; manual; DoC; production control records (serial ↔ SIM ICCID ↔ key). | RED Annex V; Batt. Reg. Annex VIII |
| CE marking | At least 5 mm high (Reg. 765/2008 Annex II), on the product and the packaging (RED Art. 19–20). Mould it into the core, inside the battery cap, or deboss it into the PU skin, together with the bin symbol, model "Lemon B", serial and short address. Everything also goes on the box and in the manual. | RED Arts. 10(6)–(7), 19–20 |
| Languages | Dutch for NL; each sales country's language (FR/NL/DE for Belgium, DE for Germany, etc.). | RED Art. 10(8); Batt. Reg. Art. 38; GPSR Art. 9(7) |
| Cellular operator | EU law does not require GCF/PTCRB (the nRF9151 itself is GCF/PTCRB certified). 1NCE GTC: services are sold only to businesses (§1.3), so you need a KvK registration first. 1NCE may block "non-network-compliant terminal devices". Use is allowed "as an integral part of an IoT solution provided … to third parties (end users)" (§4.1). Permanent roaming: 1NCE "is not obliged" to serve countries that ban or restrict it (Connect terms §1.2). NL status is UNVERIFIED; ask 1NCE in writing for NL/BE/DE LTE-M roaming partners and permanent-roaming acceptance. | 1NCE GmbH GTC 01/2026; 1NCE Connect terms |
| GDPR | The relay VPS processes pairing, IP/ICCID and timing data. You need a privacy notice, records of processing and data minimisation. | GDPR (not detailed here) |
5. Test plan, costs and timeline
No EU lab publishes prices. Dekra NL, Kiwa, TÜV, Element, Nemko, Eurofins, 7layers and CETECOM all quote per project. The figures below are UNVERIFIED estimates. Send the same RFQ (this section plus the rev B sample description) to at least three labs. 7layers and CETECOM are cellular and NB specialists; Dekra and Kiwa are in NL.
| # | Item | Low € | Expected € | High € | Weeks |
|---|---|---|---|---|---|
| 1 | In-house pre-compliance (NanoVNA, TinySA, near-field probes, thermal and drop tests) plus 1 day lab pre-scan for radiated emissions and EMC | 1,000 | 2,000 | 3,000 | 2 |
| 2 | Lemon: EN 301 908-1/-13 radiated spurious (conducted results reused from Nordic) | 3,000 | 5,000 | 8,000 | 2–3 |
| 3 | Lemon: EN 301 489-1/-52/-3 EMC | 2,500 | 4,000 | 6,000 | 1–2 |
| 4 | Lemon: EN IEC 62368-1 (incl. battery and charging abnormal tests) | 3,000 | 5,000 | 7,000 | 3–4 |
| 5 | Lemon: SAR EN 50566, limb and trunk at 0 mm, bands 3/8/20 (≈€0–1k if the low-power exclusion is accepted) | 0 | 5,000 | 8,000 | 2 |
| 6 | Lemon: EN 18031-1/-2 assessment (lab or consultant review of your self-assessment) | 3,000 | 7,000 | 12,000 | 3–6 |
| 7 | Cradle and system: EN 303 417 (with Lemon), EN 301 489-1/-3, EN IEC 62368-1, EN 62479 | 4,000 | 6,500 | 9,000 | 2–3 |
| 8 | NB Annex III type-examination (TRP/TRS and/or EN 18031 caveats) | 0 | 4,000 | 10,000 | 4–8 |
| 9 | Cell IEC 62133-2 + UN38.3 (€0 if the supplier provides valid reports) | 0 | 1,500 | 8,000 | 0 / 8 |
| 10 | Retest after one fix (typically radiated emissions or ESD) | 1,000 | 2,500 | 5,000 | 2 |
| 11 | Chemicals: PU PAH and phthalate screening, supplier declarations | 300 | 800 | 1,500 | 2 |
| 12 | Diisocyanate training, translations (NL/DE/FR), labels, legal review of the DoC and manual | 400 | 1,500 | 3,000 | – |
| 13 | Registrations: OPEN (WEEE and batteries), KvK; year-1 fees NL only | 100 | 200 | 400 | 1 |
| 14 | Product liability insurance, first year (not strictly compliance) | 500 | 900 | 1,500 | – |
| Total (NL only, not a toy) | ≈18,800 | ≈45,900 | ≈82,400 | ≈10–16 wk | |
| Extra if classified as a toy (EN 71-1/-2/-3, EN IEC 62115) | 4,000 | 6,000 | 8,000 | 3 | |
| Extra per additional EU country (EPR authorised representative, WEEE, batteries, packaging, translation) | 800 | 1,500 | 3,000 | 4–8 |
How to stay near €30–35k: - Test rev B only and bundle the Lemon and cradle at one lab that is also an NB. - Buy cells with IEC 62133-2/UN38.3 reports and a battery DoC. - Argue the SAR low-power exclusion using logged duty cycles. - Do the EN 18031 self-assessment yourself, with the lab only reviewing it. - Sell in NL (and possibly BE) only in batch 1. - Expected spend (~€46k) is close to the whole €50k budget. Plan the batch so compliance comes out of pre-orders, or cut scope.
Order of work (from today): 1. Freeze the rev B design with the battery-access change. 2. Pre-scan in weeks 1–6. 3. Send RFQs in week 2, with an NB opinion on TRP/TRS and EN 18031. 4. Formal tests in weeks 8–14. 5. Write the DoC and technical file, register with OPEN, and start selling around week 16 (early Jan 2027 at the earliest).
6. Design changes required by compliance
- Battery access (Batt. Reg. Art. 11): - Openable twist-lock cap or 2 standard screws; no glue or potting over the cell. - Keyed connector; standard 602025+PCM spare with a published spec. - Removal instructions online; 5 years of spares.
- Labelling space: a flat ≥12×20 mm area inside the cap or on the Qi face for CE (≥5 mm), the bin symbol, model, serial and manufacturer name/URL. QR code and battery collection symbol on the box.
- Cybersecurity (EN 18031-1/-2, CRA-ready):
- Disable debug access in production. Turn on nRF APPROTECT/SECURE APPROTECT and compile out the UART
lemonshell. Key provisioning happens only in the factory jig. - Unique per-device keys stored in the nRF KMU/secure storage. Never a shared or default key; no passwords, so the password caveat is avoided. - Secure boot with MCUboot signature checking. - Signed, rollback-protected FOTA for the application (and modem firmware via Nordic delta DFU). A few hundred kB fits the 500 MB SIM budget. - Authenticated and replay-protected datagrams (AES-CCM with sequence counters). Consider encrypting the payload as well. - Rate-limit inbound packets (resilience) and make the device fail safe if the server is unreachable. - Factory reset / data deletion (re-pairing wipes keys and partner ID) for resale. - Vulnerability handling: a security.txt/e-mail contact, a published support period, and a CRA Art. 14 reporting procedure (in force now). - Data minimisation: no location, no stored message history; the server keeps only what is needed to route messages, with short log retention. - Safety: - Validate the PCM plus charger with NTC/over-temperature behaviour. The BQ51013B/MCP73831 path has no cell NTC now, so add one if the IEC 62368-1 Annex M review asks for it. - Skin temperature during Qi charging must stay ≤ TS1 limits. - The cradle must limit foreign-object heating (Qi FOD).
- RF exposure: keep the antenna at the +X tip away from the squeeze zone. Log real TX duty cycle to support the SAR or low-power argument.
- Toy avoidance: adult-oriented design language, packaging, ads and age statement. Nubs and sleeve must survive pull and bite tests anyway (GPSR).
- Materials: a phthalate-free, organotin-free PU system with SDS and an SVHC declaration; certified diisocyanate training for whoever casts.